Diabetes MellitusNCT04652999
Relaxation Intervention in Patients With Diabetic Foot Ulcer
A study testing Muscle Relaxation with Guided Imagery and Neutral Guided Imagery in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by University of Minho at 2 sites in Portugal.
Trial summary
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Diabetic Foot Ulcer
- What is being tested?
- Muscle Relaxation with Guided Imagery and Neutral Guided Imagery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 2 sitesPortugal
- Study dates
- 19 Mar 2019to 30 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diabetes Mellitus diagnosis;
- Diagnosis of Diabetic Foot;
- Having one or two active chronic ulcers (> 6 weeks) at the time of the assessment;
- Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Hospital de Braga;
- Presenting clinical levels of stress (scores greater than 13 for males and greater than 17 for females on the Perceived Stress Scale) or anxiety or depression (scores greater than 11 on Hospital Anxiety and Depression Scale).
Who cannot join
- The active DFU at the time of the assessment being a relapse;
- Having more than two DFU currently active;
- Being on hemodialysis treatment;
- Presence of psychosis or dementia described in the patient's medical record;
- Having cancer disease;
- Having undergone a transplant;
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- Receiving psychological counselling at the time of the assessment.
- For the qualitative study nested in the Pilot RCT, participants must meet the same inclusion and exclusion criteria defined above, plus being allocated to the EG and have completed the four intervention sessions. From those participants, the following cases will be selected:
- Three typical cases of patients with neuropathic foot defined by the presence of neuropathic pain (e.g., heat, tingling, electrical shock), presence of distal pulses by palpation, and loss of protective sensitivity;
- Three typical cases of patients with neuroischemic foot defined by the presence of peripheral artery disease, intense-variable pain, absence of distal pulses by palpation, and variable protective sensitivity.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Clínica do Pé Diabético, Centro Hospitalar do Tâmega e Sousa
Penafiel, 4564-007
Centro Hospitalar Universitário do Porto
Porto, 4099-001
About this study
Official title: Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU.
This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations.
Read more
Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care.
The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
Read the detailed description
General Aims:
This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - GE) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), prior to the implementation of a future definitive RCT that will assess its effectiveness.
This study will also examine, qualitatively, the perspectives of patients with DFU regarding the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the multidisciplinary team of diabetic foot consultations.
Pilot RCT specific aims:
- To evaluate the rates of eligibility, recruitment and adherence to the study protocol, participation in follow-up, and withdrawal. The degree of patient satisfaction with the relaxation intervention will also be assessed.
- To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures (degree of DFU healing, DFU-related quality of life, anxiety, depression and stress, DFU representations and physical and mental quality of life);
- Synthesize the information to estimate the sample size required for a future definitive RCT. Qualitative study nested in Pilot RCT specific aims:
- To understand the perspective of patients and health professionals about the relaxation sessions;
- To explore the contribution of the relaxation sessions to the DFU healing and patients' quality of life;
- To describe the changes perceived in the patient during the period of relaxation sessions;
- To analyse the relevance of implementing relaxation sessions in the multidisciplinary team consultation of diabetic foot.
Data Analysis:
To assess the feasibility of this pilot study (aim 1), the rates of eligibility, recruitment and adherence to the study protocol, participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage. The results of the degree of satisfaction with the intervention will be presented through mean and standard deviation. To obtain preliminary estimates of the intervention effects' on health outcome measures (aim 2), descriptive measures of the respective variables (means and standard deviations) will be calculated and Generalised Mixed Models will be used to check for statistically significant differences over time, in the different groups. Data will be analysed using IBM SPSS Statistics 26 for Mac. Finally, from the data obtained, the sample size for a future definitive RCT will be calculated (aim 3).
To answer the aims 4 to 7, a semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. This script will remain unchanged throughout the interviews. The audio recording of the interviews will be done using a tablet, transcribed verbatim and anonymised in order to safeguard participants and data confidentiality. The transcripts of the interviews will be analysed in the same order as conducted, using the thematic content analysis technique (Bardin, 2016).
Sample size calculation:
The sample size calculation for a pilot RCT, considering the average effect size of 0.5, a statistical power of 80% and a significance level of 5%, revealed that 12 participants were needed in each of the groups (Cocks \& Torgerson, 2013). This approach considers that a one-sided 80% confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true (Brown \& Lilford, 2006).
Procedure:
The doctor or nurse, in the medical appointment, identifies patients that meet the medical inclusion criteria. Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent. If patients agree to participate, they will sign the consent form. Nurses will then complete RESVECH 2.0 at the end of the appointment and doctors will complete the clinical questionnaire. Afterwards, the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format.
After answering the questionnaires, the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress, anxiety and depression, and if the patient is eligible, at the end of that week, the participant will be randomized into one of three possible groups.
In the next diabetic foot appointment, the respective participant will be informed about the group to which he or she has been allocated and whether will benefit, if appropriate, from four sessions of relaxation (EG) or neutral guided imagery (ACG), depending on the group. If the participant is available, the first session will take place on the same day. The following sessions will be scheduled according to the medical diabetic foot consultations. In each session, two assessments of blood pressure and heart rate will be performed, before starting the session and at the end of the session. At the end of the fourth session, the T1 assessment will be performed, with a new administration of the questionnaires. Six months after T0, the T2 (follow-up) evaluation will take place, with the last administration of the questionnaires.
The interviews with patients, who completed the four sessions of relaxation, and with health professionals, will be conducted two weeks after T1, by a different researcher than the one involved in the intervention, to reduce the bias of social desirability.
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer
- Being tested
- Muscle Relaxation with Guided Imagery, Neutral Guided Imagery
- Keywords
- Diabetic Foot Ulcer, Relaxation, Ulcer Healing, Quality of Life, Pilot RCT
- Medical subject headings
- Diabetes Mellitus, Diabetic Foot
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Muscle Relaxation with Guided ImageryBehavioural
Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot). The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds. The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
Neutral Guided ImageryBehavioural
This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.
| Study group | Role | What they receive |
|---|---|---|
| Muscle Relaxation with Guided Imagery | Experimental | The participants in Experimental Group will receive four individual 45-minute sessions, every two weeks, of progressive muscle relaxation intervention with guided imagery focused on ulcer healing, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments. Receives: Behavioral: Muscle Relaxation with Guided Imagery |
| Active Control Group | Placebo comparator | Participants in the Active Control Group will receive four individual 45-minute sessions of neutral guided imagery placebo, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments. Receives: Behavioral: Neutral Guided Imagery |
| Passive Control Group | No intervention | The participants in the Passive Control Group will not receive any intervention nor placebo session. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of eligibility
This rate will result from the proportion between the number of eligible patients and the total number of observed patients, in percentage.
Measured: Baseline (T0)
Rate of recruitment
This rate will result from the proportion between the number of patients who accepted to participate and the number of eligible patients, in percentage.
Measured: Baseline (T0)
Rate of refusal
This rate will result from the proportion between the number of patients who rejected to participate in the study and the number of patients invited to participate, in percentage.
Measured: Baseline (T0)
Rate of adherence to the study protocol
This rate will result from the proportion between the number of patients who performed the assessments/intervention sessions and the number of patients who completed the baseline assessment (T0), in percentage.
Measured: Through study completion, an average of 6 months
Rate of participation in follow-up
This rate will result from the proportion between the number of patients who participated in follow-up assessment and the number of patients who completed the baseline assessment (T0), presented in percentage.
Measured: Through study completion, an average of 6 months
Rate of dropout
This rate will result from the proportion between the number of patients who dropout the study and the number of patients who completed the baseline assessment (T0), presented in percentage.
Measured: Through study completion, an average of 6 months
Patient satisfaction with the relaxation intervention
The degree of patients´ satisfaction with the relaxation intervention will be assessed through questions developed for this purpose, including the degree of general satisfaction with the sessions; the impact on stress, anxiety and depression, and wound healing after the four sessions; the degree of usefulness for patients with DFU; the desire to participate in future sessions; and the recommendation of the sessions to other patients with DFU. All the questions will be assessed on a Likert scale from 1 (very unsatisfied/ none/ totally disagree) to 5 (very satisfied/ extreme/ totally agree).
Measured: End of intervention/ 2 months later at post-test (T1)
Secondary outcomes (13)
Degree of DFU healing
The degree of DFU healing will be assessed with the Portuguese version of "Resultados esperados de la valoración y evolución de la cicatrización de las heridas crónicas" Scale [Expected results of the evaluation and evolution of the healing of chronic wounds Scale - RESVECH 2.0] (Marques, 2015). The scores range from 0 to 35, where zero indicates complete healing.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Impact of DFU on patients' Quality of Life
The Diabetic Foot Ulcer Scale-Short Form (DFS-SF; Bann, Fehnel, \& Gagnon, 2003; Research version by Pereira \& Ferreira, 2018) will be used to assess patients´ DFU-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better DFU-related quality of life.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Physical Quality of Life
The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, \& Pereira, 2012) will be administered to assess patients' physical Health-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better physical quality of life.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Mental Quality of Life
The Short-Form Health Survey (SF-36; Ferreira, 1998; Ferreira, Ferreira, \& Pereira, 2012) will be administered to assess patients' mental Health-related Quality of Life. Raw scores are transformed into a scale from 0 to 100. Higher results correspond to better mental quality of life.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Perceived Stress
The overall stress perceived by the patient will be assessed through the Perceived Stress Scale (PSS; Trigo, Canudo, Branco, \& Silva, 2010).
Scores range between 0 and 40, with higher results indicating higher levels of perceived stress.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Emotional Distress
The emotional distress will be assessed through the total score of the Hospital Anxiety and Depression Scale, comprising both anxiety and depression scales (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 42, with higher results indicating higher levels of distress.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Anxiety symptoms
The anxious symptomatology will be assessed through the Hospital Anxiety and Depression Scale (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 21, with higher results indicating higher levels of anxiety symptoms.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Depression symptoms
The depressive symptomatology will be assessed through the Hospital Anxiety and Depression Scale (HADS; Pais-Ribeiro et al., 2007). Scores range between 0 and 21, with higher results indicating higher levels of depression symptoms.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Adherence to DFU Care
Patient adherence to DFU care will be assessed through the DFU Care Adherence Questionnaire (Research Version by Pereira, Dantas, Brandão, Santos, Carvalho, \& Ferreira, 2018), which was developed for this study, according to the guidelines of the Portuguese General Direction of Health (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015). Higher scores indicate better adherence to DFU care.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Representations regarding the DFU
Patient representations regarding the DFU will be evaluated through the Illness Perception Questionnaire - Brief (IPQ-B; Figueiras et al., 2010). The response scale ranges from 0 to 10. Higher scores indicate more threatening representations regarding DFU.
Measured: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Systolic Pressure
Systolic pressure in millimeters of mercury (mmHg) will be assessed through a validated and certified blood pressure measuring device.
Measured: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Diastolic Pressure
Diastolic pressure in millimeters of mercury (mmHg) will be assessed through a validated and certified blood pressure measuring device.
Measured: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Heart rate
Heart rate in beats per minute (bpm) will be assessed through a validated and certified blood pressure measuring device.
Measured: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2020
- Study start19 Mar 2019
- Primary completion30 Sep 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Pilot Randomised Controlled Study of a Psychological Intervention (Eldridge et al., 2016; Grant et al., 2018). This study will use a mixed-methods approach nested in a pilot 3-arm randomized control design. Qualitative and quantitative data will be collected in order to provide better understanding about the feasibility and acceptability of the relaxation intervention in patients with DFU. Participants will be randomised at a ratio of 1:1 for the three conditions - EG, ACG and PCG; and will be evaluated on the day of the first chronic DFU appointment or nursing treatment (T0), two months later (at the end of the intervention in EG and ACG; T1), as well as six months later (T2) in a follow-up evaluation. Participants from all three groups will undergo standard treatment for the DFU, according to the guidelines of the Portuguese General Health Direction (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minho
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Responsible party
- Principal investigator, Gabriela Ferreira, University of Minho
- Investigators
- Gabriela Ferreira, Master, Principal investigator, School of Psychology, University of MinhoM.Graça Pereira, PhD, Study director, School of Psychology, University of Minho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04652999
- Sponsor's protocol ID
- CEICVS015/2019
- Status last verified
- May 2022
- First submitted
- 30 Oct 2020
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
PubMed 14986739Bardin L. Análise de Conteúdo [Content Analysis]. 2016; São Paulo, Brasil: Almedina. Brasil.
Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
PubMed 17092344Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
PubMed 23195919Direção-Geral de Saúde, DGS [General Health Direction, Portugal] Circular Normativa Nº:05/PNPCD: Pé Diabético, Programa Nacional de Prevenção e Controlo da Diabetes (PNPCD) [Normative Circular Nº: 05 / PNPCD: Diabetic Foot, National Diabetes Prevention and Control Program]; 2010. Retrieved from http://www.dgs.pt/?cr=15718
Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
PubMed 27965879Ferreira P. A medição do estado de saúde: Criação da versão portuguesa do MOS SF-36 [Measuring health status: Creation of the Portuguese version of MOS SF-36]. Coimbra: Centro de Estudos e Investigação em Saúde, Faculdade de Economia, Universidade de Coimbra; 1998.
Ferreira PL, Ferreira LN, Pereira LN. Medidas sumário física e mental de estado de saúde para a população portuguesa [Physical and mental summary measures of health state for the Portuguese population]. Revista Portuguesa de Saúde Pública. 2012;30(2):163-171. doi:10.1016/j.rpsp.2012.12.007.
Ferreira V, Martins J, Loureiro L, Loureiro T, Borges L, Silveira D, … Almeida R. Consulta multidisciplinar do pé diabético: Avaliação dos fatores de mau prognóstico [Multidisciplinary consultation of diabetic foot - factors related with bad prognosis]. Angiologia e Cirurgia Vascular. 2014;10:146-150. doi:10.1016/j.ancv.2014.08.005
Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.
PubMed 20204931Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.
PubMed 30060763International Working Group on the Diabetic Foot [IWGDF] International Consensus on the Diabetic Foot. International Diabetes Foundation; 2015. Retrieved from http://www.iwgdf.org/files/2015/website_prevention.pdf
Marques JM. Adaptação cultural e validação para a população portuguesa de um instrumento de monitorização de feridas crónicas - escala RESVECH 2.0 [Cultural adaptation and validation for the Portuguese population of a chronic wound monitoring instrument - RESVECH 2.0 scale] (Master's Thesis). Instituto de Ciências da Saúde da Universidade Católica, Porto; 2015.
Pais-Ribeiro J, Silva I, Ferreira T, Martins A, Meneses R, Baltar M. Validation study of a Portuguese version of the Hospital Anxiety and Depression Scale. Psychol Health Med. 2007 Mar;12(2):225-35; quiz 235-7. doi: 10.1080/13548500500524088. English, Portuguese.
PubMed 17365902Paiva D, Silva S, Severo M, Ferreira P, Santos O, Lunet N, Azevedo A. Cross-cultural adaptation and validation of the health literacy assessment tool METER in the Portuguese adult population. Patient Educ Couns. 2014 Nov;97(2):269-75. doi: 10.1016/j.pec.2014.07.024. Epub 2014 Jul 22.
PubMed 25107513
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relaxation Intervention in Patients With Diabetic Foot Ulcer: A Pilot Randomized Controlled Trial With a Nested Qualitative Study
- ClinicalTrials.gov ID
- NCT04652999
- Acronym / sponsor ID
- CEICVS015/2019
- Conditions
- Diabetes Mellitus, Diabetic Foot Ulcer
- Keywords
- Diabetic Foot Ulcer, Relaxation, Ulcer Healing, Quality of Life, Pilot RCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of MinhoUniversity, hospital or other
- Collaborators
- Foundation for Science and Technology, Portugal
- Study start
- 19 Mar 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 4 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Diabetic foot ulcers (DFU) are one of the most serious complications of diabetes and can lead to amputations in 85% of cases, resulting in physical, psychological, family, social and economic consequences. Psychological interventions can contribute to the improvement of wound healing and, relaxation, in particular, seems to contribute to faster wound healing. More research is needed to assess the effectiveness of different types of intervention on different types of wounds, in particular on chronic wounds such as DFU.
This is a Pilot Randomised Controlled Study of a Psychological Intervention that aims to evaluate the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - EG) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), to inform a future definitive Randomised Controlled Study (RCT) that tests its effectiveness. This study will also examine, qualitatively, the perspectives of patients with DFU on the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the care system of multidisciplinary diabetic foot consultations.
Participants have a diagnosis of Diabetes Mellitus and Diabetic Foot; one or two chronic ulcers active at the time of assessment; and clinical levels of stress or anxiety or depression. Participants will be randomized by the three conditions - EG, ACG and PCG - and assessed on the day of the first consultation or nursing treatment for chronic DFU (T0), two months later (T1), and six months later (T2; follow-up). Two weeks after T1, an interview will be conducted with patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care.
The results of the present study will contribute for a better understanding of DFU progression, healing, prevention of re-ulceration and future amputations and, consequently, for the improvement of patients' quality of life.
Detailed description
General Aims:
This pilot RCT aims to assess the feasibility and acceptability of a muscle relaxation intervention with guided imagery (experimental group - GE) compared to a neutral guided imagery placebo (active control group - ACG) and a group that does not receive any psychological intervention (passive control group - PCG), prior to the implementation of a future definitive RCT that will assess its effectiveness.
This study will also examine, qualitatively, the perspectives of patients with DFU regarding the relaxation intervention, in order to check its acceptability and applicability; as well as the perspectives of health professionals on this adjuvant therapy, its applicability and integration into the multidisciplinary team of diabetic foot consultations.
Pilot RCT specific aims:
- To evaluate the rates of eligibility, recruitment and adherence to the study protocol, participation in follow-up, and withdrawal. The degree of patient satisfaction with the relaxation intervention will also be assessed.
- To verify the feasibility of the assessment protocol and to obtain preliminary estimates of the effects of the intervention on health outcome measures (degree of DFU healing, DFU-related quality of life, anxiety, depression and stress, DFU representations and physical and mental quality of life);
- Synthesize the information to estimate the sample size required for a future definitive RCT. Qualitative study nested in Pilot RCT specific aims:
- To understand the perspective of patients and health professionals about the relaxation sessions;
- To explore the contribution of the relaxation sessions to the DFU healing and patients' quality of life;
- To describe the changes perceived in the patient during the period of relaxation sessions;
- To analyse the relevance of implementing relaxation sessions in the multidisciplinary team consultation of diabetic foot.
Data Analysis:
To assess the feasibility of this pilot study (aim 1), the rates of eligibility, recruitment and adherence to the study protocol, participation in the follow-up and withdrawal will be calculated and its results will be presented in percentage. The results of the degree of satisfaction with the intervention will be presented through mean and standard deviation. To obtain preliminary estimates of the intervention effects' on health outcome measures (aim 2), descriptive measures of the respective variables (means and standard deviations) will be calculated and Generalised Mixed Models will be used to check for statistically significant differences over time, in the different groups. Data will be analysed using IBM SPSS Statistics 26 for Mac. Finally, from the data obtained, the sample size for a future definitive RCT will be calculated (aim 3).
To answer the aims 4 to 7, a semi-structured interview guide consisting of open-ended questions will be administered to patients with DFU that benefited from the relaxation sessions and to the health professionals who provided them the DFU care. This script will remain unchanged throughout the interviews. The audio recording of the interviews will be done using a tablet, transcribed verbatim and anonymised in order to safeguard participants and data confidentiality. The transcripts of the interviews will be analysed in the same order as conducted, using the thematic content analysis technique (Bardin, 2016).
Sample size calculation:
The sample size calculation for a pilot RCT, considering the average effect size of 0.5, a statistical power of 80% and a significance level of 5%, revealed that 12 participants were needed in each of the groups (Cocks \& Torgerson, 2013). This approach considers that a one-sided 80% confidence interval for the effect size will exclude the minimum clinically significant difference if the null hypothesis is true (Brown \& Lilford, 2006).
Procedure:
The doctor or nurse, in the medical appointment, identifies patients that meet the medical inclusion criteria. Patients are invited to participate in the study by the Researcher at the end of the medical appointment and are informed about the aims of the study and the voluntary nature of participation through informed and informative consent. If patients agree to participate, they will sign the consent form. Nurses will then complete RESVECH 2.0 at the end of the appointment and doctors will complete the clinical questionnaire. Afterwards, the Researcher will accompany the patient to a room provided by the Hospital in order to administer the battery of questionnaires in the interview format.
After answering the questionnaires, the researcher will score the PSS and HADS instruments to identify the presence of significant clinical levels of stress, anxiety and depression, and if the patient is eligible, at the end of that week, the participant will be randomized into one of three possible groups.
In the next diabetic foot appointment, the respective participant will be informed about the group to which he or she has been allocated and whether will benefit, if appropriate, from four sessions of relaxation (EG) or neutral guided imagery (ACG), depending on the group. If the participant is available, the first session will take place on the same day. The following sessions will be scheduled according to the medical diabetic foot consultations. In each session, two assessments of blood pressure and heart rate will be performed, before starting the session and at the end of the session. At the end of the fourth session, the T1 assessment will be performed, with a new administration of the questionnaires. Six months after T0, the T2 (follow-up) evaluation will take place, with the last administration of the questionnaires.
The interviews with patients, who completed the four sessions of relaxation, and with health professionals, will be conducted two weeks after T1, by a different researcher than the one involved in the intervention, to reduce the bias of social desirability.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a Pilot Randomised Controlled Study of a Psychological Intervention (Eldridge et al., 2016; Grant et al., 2018). This study will use a mixed-methods approach nested in a pilot 3-arm randomized control design. Qualitative and quantitative data will be collected in order to provide better understanding about the feasibility and acceptability of the relaxation intervention in patients with DFU. Participants will be randomised at a ratio of 1:1 for the three conditions - EG, ACG and PCG; and will be evaluated on the day of the first chronic DFU appointment or nursing treatment (T0), two months later (at the end of the intervention in EG and ACG; T1), as well as six months later (T2) in a follow-up evaluation. Participants from all three groups will undergo standard treatment for the DFU, according to the guidelines of the Portuguese General Health Direction (DGS, 2010) and the International Working Group on the Diabetic Foot (IWGDF, 2015).
| Arm | Type | Receives |
|---|---|---|
| Muscle Relaxation with Guided Imagery | Experimental | Behavioral: Muscle Relaxation with Guided ImageryThe participants in Experimental Group will receive four individual 45-minute sessions, every two weeks, of progressive muscle relaxation intervention with guided imagery focused on ulcer healing, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments. |
| Active Control Group | Placebo comparator | Behavioral: Neutral Guided ImageryParticipants in the Active Control Group will receive four individual 45-minute sessions of neutral guided imagery placebo, carried out by the Psychologist responsible for implementing the project, on the day of the Diabetic Foot appointments. |
| Passive Control Group | No intervention | –The participants in the Passive Control Group will not receive any intervention nor placebo session. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diabetes Mellitus diagnosis;
- Diagnosis of Diabetic Foot;
- Having one or two active chronic ulcers (> 6 weeks) at the time of the assessment;
- Being followed at the Multidisciplinary Consultation of the Diabetic Foot from the Centro Hospitalar Universitário do Porto (CHUP), at the Diabetic Foot Clinic from the Centro Hospitalar do Tâmega e Sousa (CHTS) and from the Hospital de Braga;
- Presenting clinical levels of stress (scores greater than 13 for males and greater than 17 for females on the Perceived Stress Scale) or anxiety or depression (scores greater than 11 on Hospital Anxiety and Depression Scale).
Key exclusion criteria (10 listed)
- The active DFU at the time of the assessment being a relapse;
- Having more than two DFU currently active;
- Being on hemodialysis treatment;
- Presence of psychosis or dementia described in the patient's medical record;
- Having cancer disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Muscle Relaxation with Guided ImageryRelaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot). The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds. The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it. | Behavioural | Muscle Relaxation with Guided Imagery |
| Neutral Guided ImageryThis placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given. | Behavioural | Active Control Group |
Primary outcome
Rate of eligibility
Time frame: Baseline (T0)
This rate will result from the proportion between the number of eligible patients and the total number of observed patients, in percentage.
Rate of recruitment
Time frame: Baseline (T0)
This rate will result from the proportion between the number of patients who accepted to participate and the number of eligible patients, in percentage.
Rate of refusal
Time frame: Baseline (T0)
This rate will result from the proportion between the number of patients who rejected to participate in the study and the number of patients invited to participate, in percentage.
Rate of adherence to the study protocol
Time frame: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who performed the assessments/intervention sessions and the number of patients who completed the baseline assessment (T0), in percentage.
Rate of participation in follow-up
Time frame: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who participated in follow-up assessment and the number of patients who completed the baseline assessment (T0), presented in percentage.
Rate of dropout
Time frame: Through study completion, an average of 6 months
This rate will result from the proportion between the number of patients who dropout the study and the number of patients who completed the baseline assessment (T0), presented in percentage.
Patient satisfaction with the relaxation intervention
Time frame: End of intervention/ 2 months later at post-test (T1)
The degree of patients´ satisfaction with the relaxation intervention will be assessed through questions developed for this purpose, including the degree of general satisfaction with the sessions; the impact on stress, anxiety and depression, and wound healing after the four sessions; the degree of usefulness for patients with DFU; the desire to participate in future sessions; and the recommendation of the sessions to other patients with DFU. All the questions will be assessed on a Likert scale from 1 (very unsatisfied/ none/ totally disagree) to 5 (very satisfied/ extreme/ totally agree).
13 secondary outcomes
Degree of DFU healing
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Impact of DFU on patients' Quality of Life
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Physical Quality of Life
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Mental Quality of Life
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Perceived Stress
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Emotional Distress
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Anxiety symptoms
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Depression symptoms
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Adherence to DFU Care
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Representations regarding the DFU
Time frame: Changes from baseline (T0) to the end of intervention/ 2 months later at post-test (T1), and after a six month follow-up (T2)
Systolic Pressure
Time frame: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Diastolic Pressure
Time frame: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Heart rate
Time frame: Before and after each intervention (EG) or placebo (ACG) at 2 weeks (1st Session), 4 weeks (2nd Session), 6 weeks (3rd Session) and 8 weeks (4th Session), after the baseline (T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 14986739Bann CM, Fehnel SE, Gagnon DD. Development and validation of the Diabetic Foot Ulcer Scale-short form (DFS-SF). Pharmacoeconomics. 2003;21(17):1277-90. doi: 10.2165/00019053-200321170-00004.
- BackgroundBardin L. Análise de Conteúdo [Content Analysis]. 2016; São Paulo, Brasil: Almedina. Brasil.
- Background: PubMed 17092344Brown CA, Lilford RJ. The stepped wedge trial design: a systematic review. BMC Med Res Methodol. 2006 Nov 8;6:54. doi: 10.1186/1471-2288-6-54.
- Background: PubMed 23195919Cocks K, Torgerson DJ. Sample size calculations for pilot randomized trials: a confidence interval approach. J Clin Epidemiol. 2013 Feb;66(2):197-201. doi: 10.1016/j.jclinepi.2012.09.002. Epub 2012 Nov 27.
- BackgroundDireção-Geral de Saúde, DGS [General Health Direction, Portugal] Circular Normativa Nº:05/PNPCD: Pé Diabético, Programa Nacional de Prevenção e Controlo da Diabetes (PNPCD) [Normative Circular Nº: 05 / PNPCD: Diabetic Foot, National Diabetes Prevention and Control Program]; 2010. Retrieved from http://www.dgs.pt/?cr=15718
- Background: PubMed 27965879Eldridge SM, Chan CL, Campbell MJ, Bond CM, Hopewell S, Thabane L, Lancaster GA; PAFS consensus group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. Pilot Feasibility Stud. 2016 Oct 21;2:64. doi: 10.1186/s40814-016-0105-8. eCollection 2016.
- BackgroundFerreira P. A medição do estado de saúde: Criação da versão portuguesa do MOS SF-36 [Measuring health status: Creation of the Portuguese version of MOS SF-36]. Coimbra: Centro de Estudos e Investigação em Saúde, Faculdade de Economia, Universidade de Coimbra; 1998.
- BackgroundFerreira PL, Ferreira LN, Pereira LN. Medidas sumário física e mental de estado de saúde para a população portuguesa [Physical and mental summary measures of health state for the Portuguese population]. Revista Portuguesa de Saúde Pública. 2012;30(2):163-171. doi:10.1016/j.rpsp.2012.12.007.
- BackgroundFerreira V, Martins J, Loureiro L, Loureiro T, Borges L, Silveira D, … Almeida R. Consulta multidisciplinar do pé diabético: Avaliação dos fatores de mau prognóstico [Multidisciplinary consultation of diabetic foot - factors related with bad prognosis]. Angiologia e Cirurgia Vascular. 2014;10:146-150. doi:10.1016/j.ancv.2014.08.005
- Background: PubMed 20204931Figueiras M, Marcelino DS, Claudino A, Cortes MA, Maroco J, Weinman J. Patients' illness schemata of hypertension: the role of beliefs for the choice of treatment. Psychol Health. 2010 Apr;25(4):507-17. doi: 10.1080/08870440802578961.
- Background: PubMed 30060763Grant S, Mayo-Wilson E, Montgomery P, Macdonald G, Michie S, Hopewell S, Moher D; , on behalf of the CONSORT-SPI Group. CONSORT-SPI 2018 Explanation and Elaboration: guidance for reporting social and psychological intervention trials. Trials. 2018 Jul 31;19(1):406. doi: 10.1186/s13063-018-2735-z.
- BackgroundInternational Working Group on the Diabetic Foot [IWGDF] International Consensus on the Diabetic Foot. International Diabetes Foundation; 2015. Retrieved from http://www.iwgdf.org/files/2015/website_prevention.pdf
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Ferreira, Master principal investigator
School of Psychology, University of Minho
M.Graça Pereira, PhD study director
School of Psychology, University of Minho
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Muscle Relaxation with Guided Imagery and Neutral Guided Imagery in people with Diabetes Mellitus and Diabetic Foot Ulcer, run by University of Minho at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of eligibility (time frame: Baseline (T0)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04652999, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.