QuadrantectomiesCAMPNCT04845334
Complementary and Alternative Medicine Interventions in Targeting Pain
A study testing RR intervention in people with Quadrantectomies and Spinal Fusion, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
Trial summary
This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quadrantectomies, Spinal Fusion, Carotid Stenosis
- What is being tested?
- RR intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Jun 2017
- 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
- patients waiting for a surgical intervention in the Departments of Vascular Surgery, General Surgery and Neurosurgery;
- age ≥ 18 years.
Who cannot join
- having a poor knowledge of the Italian language;
- having a cognitive impairment;
- having a certified psychiatric diagnosis;
- having a certified diagnosis of a neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease, etc.)
- having been in psychiatric or psychological therapy in the last 6 months
About this study
This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention.
Researches hypothesized that compared to controls patients undergoing modified RR intervention were characterized by
- improved capability to discriminate emotions from bodily feelings;
- reduce emotional distress;
- reduced pain perception.
Moreover, researches hypothesized that (4) these effects were maintained over time.
Read the detailed description
A Controlled Randomized Clinical Trial of a RR intervention for surgical patients was conducted in the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.
Fifty-six patients were treated with the clinical RR intervention, while 62 patients were recruited as controls.
Variables were assessed through an ad hoc questionnaire and a pool of self-report questionnaires validated for the Italian population: the Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the Impact of Event Scale - Revised (IES-R), the Numeric Rating Scale (NRS), and the Emotion Thermometer (ET).
The TAS-20 is a frequently used 20-items self-report measure of alexithymia. A score ≥ 61 is considered to be indicative of alexithymia, whereas scores between 51 and 60 indicate borderline alexithymia. It has a 3-factor structure: Difficulty in Identifying Feelings (TAS-DIF); Difficulty in Describing Feelings (TAS-DDF), and Externally Oriented Thinking (TAS-EOT).
The HADS is a brief, reliable self-report measure used to assess anxiety and depression in hospitalized and ambulatory medical patients, as well as in primary care and research. It consists of 7 items for anxiety (HADS-A) and 7 for depression (HADS-D). Scores > 8 in each subscale are indicative of clinically relevant anxiety and depression, respectively.
The IES-R is a widely used 22-items self-report measure of subjective distress caused by traumatic events. It considers three independent dimensions: intrusion, avoidance, and hyper-arousal.
The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numeric version of the visual analog scale (VAS), in which respondents select the number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.
The ET is a simple, self-report measure of four emotion domains (distress, anxiety, depression, and anger) and one non-emotion domain (need for help). Respondents have to rate each dimension on a vertical visual analogue scale (thermometer), with the anchors 0 and 10, to indicate which level of distress they experienced over the previous week.
Outcome measures were administered at 4 time-points:
T0: Baseline (3 months before the surgical intervention).
- Baseline alexithymia levels assessed with the TAS-20;
- baseline anxiety and depression levels assessed with the HADS;
- baseline post-traumatic distress assessed with the IES-R;
- baseline pain intensity assessed with the NRS;
- baseline psychological distress assessed with the ET;
- baseline use of analgesic drugs assessed with an ad hoc question.
T1: The morning before the surgical intervention.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
T2: At discharge, assessed up to 10 days.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
T3: 3 months after the surgical intervention.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
Subjects in the RR group underwent the clinical interventions between T0 and T1, while the controls underwent standard care.
Ethics
The study was reviewed and approved by the Institutional Review Board (IRB) of the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. All participants gave informed written consent before entering the study. All research procedures were conducted in accordance with the ethical standards of the committees responsible for human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Participants
Patients were recruited between January 2015 and June 2017.
Patients in the Departments of Vascular Surgery, General Surgery and Neurosurgery were included, considering their similarities for what concerns surgical impact, recovery, and post-recovery expectation. Expected surgical patients in the recruitment period were computed considering the prevalent frequency of each specific intervention in every Department:
- General Surgery: patients scheduled for right hemicolectomies (60 patients/years expected), quadrantectomies (80 patients/years expected);
- Neurosurgery: patient scheduled for spinal fusion with non-traumatic etiology (225 patients/years expected)
- Vascular Surgery: patient scheduled for carotid stenosis or abdominal aortic aneurysm (205 patients/years expected).
With an expected population of 570 surgical patients in the recruitment period, an a priori power analysis conducted with G*Power (Faul et al., 2007) indicated that a total sample size of 82 participants was required (α = 0.05; 1-β = 0.80; d = 0.25).
Randomization and blinding:
A block randomization method was used with block size of 4, stratified by age, gender and clinical conditions. A series of numbers was generated in advance using a computer program. Following completion of the baseline measures, a research assistant assigned a study group to each participant, following the series generated by the computers. This research assistant as well as the personnel involved in the RR inspired intervention were aware of the patient-group assignment. Remaining study personnel were blind to subject's group assignment. In addition, for blinded purposes, the study participants were instructed not to discuss the intervention with anyone.
- Being tested
- RR intervention
- Keywords
- Relaxation response, Surgiva stress, Pain, Distress, Emotion regulation
- Medical subject headings
- Carotid Stenosis, Aortic Aneurysm, Abdominal, Pain, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RR interventionBehavioural
The short psychological intervention consists of a narrative interview and a psychocorporeal intervention. Narrative interview: this is an interview aimed at exploring the experience and awareness of illness. The sharing of the dimension of pain and suffering, the verbalization of emotions, the narration of the history of illness, expectations and fears related to the intervention will be aimed at an emotional and cognitive restructuring of the experience of illness, improving the perception of internal resources and resilience.
Psycho-corporeal intervention:it is a training to the psychophysiological technique of the "Relaxation Response" (R.R.) of Hebert Benson (Mind-Body Medical Institute of Havard), aimed at stress management and consequently at reducing the perception of pain
| Study group | Role | What they receive |
|---|---|---|
| Clinical RR intervention | Experimental | Clinical RR intervention Receives: Behavioral: RR intervention |
| Standard care | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention
Changes in the Toronto Alexithymia Scale (TAS-20) scores following a specific short psychocorporeal intervention
- Total score. Range: 20-100. Higher scores mean a worse outcome.
- Difficulty in Identifying Feelings (TAS-DIF). Range: 7-35. Higher scores mean a worse outcome.
- Difficulty in Describing Feelings (TAS-DDF). Range: 5-25. Higher scores mean a worse outcome.
- Externally Oriented Thinking (TAS-EOT). Range: 8-40. Higher scores mean a worse outcome.
Measured: Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention
Changes in anxiety and depression (HADS scores) following a specific short psycho-corporeal intervention
Changes in the Hospital Anxiety and Depression Scale (HADS) scores following a specific short psycho-corporeal intervention.
- Anxiety score. Range: 0-21. Higher scores mean a worse outcome.
- Depression score. Range: 0-21. Higher scores mean a worse outcome.
Measured: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in post-traumatic distress (IES-R scores) following a specific short psycho-corporeal intervention
Changes in the Impact of Event Scale - Revised (IES-R) scores following a specific short psycho-corporeal intervention
- Total score. Range: 0-88. Higher scores mean a worse outcome.
- Hyperarousal subscale. Range: 0-4. Higher scores mean a worse outcome.
- Avoidance subscale. Range: 0-4. Higher scores mean a worse outcome.
- Intrusion subscale. Range: 0-4. Higher scores mean a worse outcome.
Measured: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in pain intensity perception (NRS scores) following a specific short psycho-corporeal intervention
Changes in the Numeric Rating Scale (NRS) scores following a specific short psycho-corporeal intervention
- Total score. Range: 0-10. Higher scores mean a worse outcome.
Measured: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in psychological distress (ET scores) following a specific short psycho-corporeal intervention
Changes in the Emotion Thermometer (ET) scores following a specific short psycho-corporeal intervention
- Distress scale. Range: 0-10. Higher scores mean a worse outcome.
- Anxiety scale. Range: 0-10. Higher scores mean a worse outcome.
- Depression scale. Range: 0-10. Higher scores mean a worse outcome.
- Anger scale. Range: 0-10. Higher scores mean a worse outcome.
- Need for help scale. Range: 0-10. Higher scores mean a worse outcome.
Measured: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Secondary outcomes (1)
Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs.
Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs
Measured: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study startJan 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for QuadrantectomiesStudies 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
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria
- Sponsor type
- University, hospital or other
- Collaborators
- Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino, Fondazione CRT
- Responsible party
- Sponsor
- Investigators
- Antonella Granieri, Professor, Study director, Dipartimento di Psicologia dell'Università degli Studi di TorinoFanny Guglielmucci, PhD, Study director, Dipartimento di Psicologia dell'Università degli Studi di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04845334
- Sponsor's protocol ID
- ASO.Psg.15.01
- Acronym
- CAMP
- Status last verified
- Jul 2021
- First submitted
- 3 Feb 2021
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Benson H, Beary JF, Carol MP. The relaxation response. Psychiatry. 1974 Feb;37(1):37-46. doi: 10.1080/00332747.1974.11023785. No abstract available.
PubMed 4810622Casey A, Chang BH, Huddleston J, Virani N, Benson H, Dusek JA. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. 2009 Jul-Aug;29(4):230-8; quiz 239-40. doi: 10.1097/HCR.0b013e3181a33352.
PubMed 19451830Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Preoperative predictors of moderate to intense acute postoperative pain in patients undergoing abdominal surgery. Acta Anaesthesiol Scand. 2002 Nov;46(10):1265-71. doi: 10.1034/j.1399-6576.2002.461015.x.
PubMed 12421200Chang BH, Casey A, Dusek JA, Benson H. Relaxation response and spirituality: Pathways to improve psychological outcomes in cardiac rehabilitation. J Psychosom Res. 2010 Aug;69(2):93-100. doi: 10.1016/j.jpsychores.2010.01.007. Epub 2010 Mar 1.
PubMed 20624507Glaros AG, Lumley MA. Alexithymia and pain in temporomandibular disorder. J Psychosom Res. 2005 Aug;59(2):85-8. doi: 10.1016/j.jpsychores.2005.05.007.
PubMed 16186003Honkalampi K, Hintikka J, Laukkanen E, Lehtonen J, Viinamaki H. Alexithymia and depression: a prospective study of patients with major depressive disorder. Psychosomatics. 2001 May-Jun;42(3):229-34. doi: 10.1176/appi.psy.42.3.229.
PubMed 11351111Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
PubMed 472086Lumley JW, Fielding GA, Rhodes M, Nathanson LK, Siu S, Stitz RW. Laparoscopic-assisted colorectal surgery. Lessons learned from 240 consecutive patients. Dis Colon Rectum. 1996 Feb;39(2):155-9. doi: 10.1007/BF02068069.
PubMed 8620781Tuzer V, Bulut SD, Bastug B, Kayalar G, Goka E, Bestepe E. Causal attributions and alexithymia in female patients with fibromyalgia or chronic low back pain. Nord J Psychiatry. 2011 Apr;65(2):138-44. doi: 10.3109/08039488.2010.522596. Epub 2010 Sep 27.
PubMed 20874000Villemure C, Bushnell CM. Cognitive modulation of pain: how do attention and emotion influence pain processing? Pain. 2002 Feb;95(3):195-199. doi: 10.1016/S0304-3959(02)00007-6. No abstract available.
PubMed 11839418Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.
PubMed 8126686Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x.
PubMed 8126688Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820Olsson I, Mykletun A, Dahl AA. The Hospital Anxiety and Depression Rating Scale: a cross-sectional study of psychometrics and case finding abilities in general practice. BMC Psychiatry. 2005 Dec 14;5:46. doi: 10.1186/1471-244X-5-46.
PubMed 16351733Craparo G, Faraci P, Rotondo G, Gori A. The Impact of Event Scale - Revised: psychometric properties of the Italian version in a sample of flood victims. Neuropsychiatr Dis Treat. 2013;9:1427-32. doi: 10.2147/NDT.S51793. Epub 2013 Sep 19.
PubMed 24092980
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complementary and Alternative Medicine Interventions in Targeting Pain
- ClinicalTrials.gov ID
- NCT04845334
- Acronym / sponsor ID
- CAMP / ASO.Psg.15.01
- Keywords
- Relaxation response, Surgiva stress, Pain, Distress, Emotion regulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di AlessandriaUniversity, hospital or other
- Collaborators
- Scuola di Specializzazione in Psicologia Clinica dell'Università degli Studi di Torino, Fondazione CRT
- Study start
- Jan 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Apr 2021 (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.
This Controlled Randomized Clinical Trial aimed at determining the effectiveness of a modified RR intervention in reducing post-operative pain and psychological symptoms in patients undergoing surgery intervention.
Researches hypothesized that compared to controls patients undergoing modified RR intervention were characterized by
- improved capability to discriminate emotions from bodily feelings;
- reduce emotional distress;
- reduced pain perception.
Moreover, researches hypothesized that (4) these effects were maintained over time.
Detailed description
A Controlled Randomized Clinical Trial of a RR intervention for surgical patients was conducted in the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy.
Fifty-six patients were treated with the clinical RR intervention, while 62 patients were recruited as controls.
Variables were assessed through an ad hoc questionnaire and a pool of self-report questionnaires validated for the Italian population: the Toronto Alexithymia Scale (TAS-20), the Hospital Anxiety and Depression Scale (HADS), the Impact of Event Scale - Revised (IES-R), the Numeric Rating Scale (NRS), and the Emotion Thermometer (ET).
The TAS-20 is a frequently used 20-items self-report measure of alexithymia. A score ≥ 61 is considered to be indicative of alexithymia, whereas scores between 51 and 60 indicate borderline alexithymia. It has a 3-factor structure: Difficulty in Identifying Feelings (TAS-DIF); Difficulty in Describing Feelings (TAS-DDF), and Externally Oriented Thinking (TAS-EOT).
The HADS is a brief, reliable self-report measure used to assess anxiety and depression in hospitalized and ambulatory medical patients, as well as in primary care and research. It consists of 7 items for anxiety (HADS-A) and 7 for depression (HADS-D). Scores > 8 in each subscale are indicative of clinically relevant anxiety and depression, respectively.
The IES-R is a widely used 22-items self-report measure of subjective distress caused by traumatic events. It considers three independent dimensions: intrusion, avoidance, and hyper-arousal.
The NRS is a unidimensional measure of pain intensity in adults. It is a segmented numeric version of the visual analog scale (VAS), in which respondents select the number (0-10 integers) that best reflects the intensity of their pain. The common format is a horizontal bar or line.
The ET is a simple, self-report measure of four emotion domains (distress, anxiety, depression, and anger) and one non-emotion domain (need for help). Respondents have to rate each dimension on a vertical visual analogue scale (thermometer), with the anchors 0 and 10, to indicate which level of distress they experienced over the previous week.
Outcome measures were administered at 4 time-points:
T0: Baseline (3 months before the surgical intervention).
- Baseline alexithymia levels assessed with the TAS-20;
- baseline anxiety and depression levels assessed with the HADS;
- baseline post-traumatic distress assessed with the IES-R;
- baseline pain intensity assessed with the NRS;
- baseline psychological distress assessed with the ET;
- baseline use of analgesic drugs assessed with an ad hoc question.
T1: The morning before the surgical intervention.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
T2: At discharge, assessed up to 10 days.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
T3: 3 months after the surgical intervention.
- Changes in alexithymia levels assessed with the TAS-20;
- changes in anxiety and depression levels assessed with the HADS;
- changes in post-traumatic distress assessed with the IES-R;
- changes in pain intensity assessed with the NRS;
- changes in psychological distress assessed with the ET;
- changes in use of analgesic drugs assessed with an ad hoc question.
Subjects in the RR group underwent the clinical interventions between T0 and T1, while the controls underwent standard care.
Ethics
The study was reviewed and approved by the Institutional Review Board (IRB) of the SS. Antonio e Biagio e Cesare Arrigo Hospital, Alessandria, Italy. All participants gave informed written consent before entering the study. All research procedures were conducted in accordance with the ethical standards of the committees responsible for human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2008.
Participants
Patients were recruited between January 2015 and June 2017.
Patients in the Departments of Vascular Surgery, General Surgery and Neurosurgery were included, considering their similarities for what concerns surgical impact, recovery, and post-recovery expectation. Expected surgical patients in the recruitment period were computed considering the prevalent frequency of each specific intervention in every Department:
- General Surgery: patients scheduled for right hemicolectomies (60 patients/years expected), quadrantectomies (80 patients/years expected);
- Neurosurgery: patient scheduled for spinal fusion with non-traumatic etiology (225 patients/years expected)
- Vascular Surgery: patient scheduled for carotid stenosis or abdominal aortic aneurysm (205 patients/years expected).
With an expected population of 570 surgical patients in the recruitment period, an a priori power analysis conducted with G*Power (Faul et al., 2007) indicated that a total sample size of 82 participants was required (α = 0.05; 1-β = 0.80; d = 0.25).
Randomization and blinding:
A block randomization method was used with block size of 4, stratified by age, gender and clinical conditions. A series of numbers was generated in advance using a computer program. Following completion of the baseline measures, a research assistant assigned a study group to each participant, following the series generated by the computers. This research assistant as well as the personnel involved in the RR inspired intervention were aware of the patient-group assignment. Remaining study personnel were blind to subject's group assignment. In addition, for blinded purposes, the study participants were instructed not to discuss the intervention with anyone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clinical RR intervention | Experimental | Behavioral: RR interventionClinical RR intervention |
| Standard care | No intervention | –Standard care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients waiting for a surgical intervention in the Departments of Vascular Surgery, General Surgery and Neurosurgery;
- age ≥ 18 years.
Key exclusion criteria (5 listed)
- having a poor knowledge of the Italian language;
- having a cognitive impairment;
- having a certified psychiatric diagnosis;
- having a certified diagnosis of a neurodegenerative disease (i.e., Alzheimer disease, Parkinson disease, etc.)
- having been in psychiatric or psychological therapy in the last 6 months
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 |
|---|---|---|
| RR interventionThe short psychological intervention consists of a narrative interview and a psychocorporeal intervention. Narrative interview: this is an interview aimed at exploring the experience and awareness of illness. The sharing of the dimension of pain and suffering, the verbalization of emotions, the narration of the history of illness, expectations and fears related to the intervention will be aimed at an emotional and cognitive restructuring of the experience of illness, improving the perception of internal resources and resilience. Psycho-corporeal intervention:it is a training to the psychophysiological technique of the "Relaxation Response" (R.R.) of Hebert Benson (Mind-Body Medical Institute of Havard), aimed at stress management and consequently at reducing the perception of pain | Behavioural | Clinical RR intervention |
Primary outcome
Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention
Time frame: Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention
Changes in the Toronto Alexithymia Scale (TAS-20) scores following a specific short psychocorporeal intervention * Total score. Range: 20-100. Higher scores mean a worse outcome. * Difficulty in Identifying Feelings (TAS-DIF). Range: 7-35. Higher scores mean a worse outcome. * Difficulty in Describing Feelings (TAS-DDF). Range: 5-25. Higher scores mean a worse outcome. * Externally Oriented Thinking (TAS-EOT). Range: 8-40. Higher scores mean a worse outcome.
Changes in anxiety and depression (HADS scores) following a specific short psycho-corporeal intervention
Time frame: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in the Hospital Anxiety and Depression Scale (HADS) scores following a specific short psycho-corporeal intervention. * Anxiety score. Range: 0-21. Higher scores mean a worse outcome. * Depression score. Range: 0-21. Higher scores mean a worse outcome.
Changes in post-traumatic distress (IES-R scores) following a specific short psycho-corporeal intervention
Time frame: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in the Impact of Event Scale - Revised (IES-R) scores following a specific short psycho-corporeal intervention * Total score. Range: 0-88. Higher scores mean a worse outcome. * Hyperarousal subscale. Range: 0-4. Higher scores mean a worse outcome. * Avoidance subscale. Range: 0-4. Higher scores mean a worse outcome. * Intrusion subscale. Range: 0-4. Higher scores mean a worse outcome.
Changes in pain intensity perception (NRS scores) following a specific short psycho-corporeal intervention
Time frame: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in the Numeric Rating Scale (NRS) scores following a specific short psycho-corporeal intervention • Total score. Range: 0-10. Higher scores mean a worse outcome.
Changes in psychological distress (ET scores) following a specific short psycho-corporeal intervention
Time frame: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
Changes in the Emotion Thermometer (ET) scores following a specific short psycho-corporeal intervention * Distress scale. Range: 0-10. Higher scores mean a worse outcome. * Anxiety scale. Range: 0-10. Higher scores mean a worse outcome. * Depression scale. Range: 0-10. Higher scores mean a worse outcome. * Anger scale. Range: 0-10. Higher scores mean a worse outcome. * Need for help scale. Range: 0-10. Higher scores mean a worse outcome.
1 secondary outcome
Effectiveness of the short psycho-corporeal intervention in reducing the use of analgesic drugs.
Time frame: [Time Frame: Baseline; The morning before the surgical intervention; At discharge from the hospital, up to 10 days after the intervention; 3 months after the surgical intervention]
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 28 Jul 2021.
- Background: PubMed 4810622Benson H, Beary JF, Carol MP. The relaxation response. Psychiatry. 1974 Feb;37(1):37-46. doi: 10.1080/00332747.1974.11023785. No abstract available.
- Background: PubMed 19451830Casey A, Chang BH, Huddleston J, Virani N, Benson H, Dusek JA. A model for integrating a mind/body approach to cardiac rehabilitation: outcomes and correlators. J Cardiopulm Rehabil Prev. 2009 Jul-Aug;29(4):230-8; quiz 239-40. doi: 10.1097/HCR.0b013e3181a33352.
- Background: PubMed 12421200Caumo W, Schmidt AP, Schneider CN, Bergmann J, Iwamoto CW, Adamatti LC, Bandeira D, Ferreira MB. Preoperative predictors of moderate to intense acute postoperative pain in patients undergoing abdominal surgery. Acta Anaesthesiol Scand. 2002 Nov;46(10):1265-71. doi: 10.1034/j.1399-6576.2002.461015.x.
- Background: PubMed 20624507Chang BH, Casey A, Dusek JA, Benson H. Relaxation response and spirituality: Pathways to improve psychological outcomes in cardiac rehabilitation. J Psychosom Res. 2010 Aug;69(2):93-100. doi: 10.1016/j.jpsychores.2010.01.007. Epub 2010 Mar 1.
- Background: PubMed 16186003Glaros AG, Lumley MA. Alexithymia and pain in temporomandibular disorder. J Psychosom Res. 2005 Aug;59(2):85-8. doi: 10.1016/j.jpsychores.2005.05.007.
- Background: PubMed 11351111Honkalampi K, Hintikka J, Laukkanen E, Lehtonen J, Viinamaki H. Alexithymia and depression: a prospective study of patients with major depressive disorder. Psychosomatics. 2001 May-Jun;42(3):229-34. doi: 10.1176/appi.psy.42.3.229.
- Background: PubMed 472086Horowitz M, Wilner N, Alvarez W. Impact of Event Scale: a measure of subjective stress. Psychosom Med. 1979 May;41(3):209-18. doi: 10.1097/00006842-197905000-00004.
- Background: PubMed 8620781Lumley JW, Fielding GA, Rhodes M, Nathanson LK, Siu S, Stitz RW. Laparoscopic-assisted colorectal surgery. Lessons learned from 240 consecutive patients. Dis Colon Rectum. 1996 Feb;39(2):155-9. doi: 10.1007/BF02068069.
- Background: PubMed 20874000Tuzer V, Bulut SD, Bastug B, Kayalar G, Goka E, Bestepe E. Causal attributions and alexithymia in female patients with fibromyalgia or chronic low back pain. Nord J Psychiatry. 2011 Apr;65(2):138-44. doi: 10.3109/08039488.2010.522596. Epub 2010 Sep 27.
- Background: PubMed 11839418Villemure C, Bushnell CM. Cognitive modulation of pain: how do attention and emotion influence pain processing? Pain. 2002 Feb;95(3):195-199. doi: 10.1016/S0304-3959(02)00007-6. No abstract available.
- Background: PubMed 8126686Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.
- Background: PubMed 8126688Bagby RM, Taylor GJ, Parker JD. The Twenty-item Toronto Alexithymia Scale--II. Convergent, discriminant, and concurrent validity. J Psychosom Res. 1994 Jan;38(1):33-40. doi: 10.1016/0022-3999(94)90006-x.
- Individual participant dataSharing planned: No
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.
Antonella Granieri, Professor study director
Dipartimento di Psicologia dell'Università degli Studi di Torino
Fanny Guglielmucci, PhD study director
Dipartimento di Psicologia dell'Università degli Studi di Torino
Questions about this trial
What is this clinical trial studying?
A study testing RR intervention in people with Quadrantectomies and Spinal Fusion, run by Azienda Ospedaliera SS. Antonio e Biagio e Cesare Arrigo di Alessandria.
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 2 inclusion and 5 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 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Changes in alexithymia (TAS scores) following a specific short psycho-corporeal intervention (time frame: Baseline; The morning before the surgical intervention; At discharge, assessed up to 10 days; 3 months after the surgical intervention). The study lists 5 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 NCT04845334, which also lists 23 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 28 Jul 2021.