HemodialysisEMBAHPPANCT06404957
Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation
A study testing Mindfulness-based Applied in people with Hemodialysis and Psychosocial Adaptation, run by Sakarya University at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment. The main question[s] it aims to answer are: Do consciously applied nursing interventions increase the psychosocial adjustment to the disease in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hemodialysis, Psychosocial Adaptation
- What is being tested?
- Mindfulness-based Applied
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jul 2022to 1 Jan 2024
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Receiving hemodialysis treatment
- Between the ages of 18-65
Who cannot join
- Patients with acute renal failure
- Current hospitalization, current ongoing chemotherapy or radiotherapy
- Cognitive dysfunction or mental retardation
- Current substance abuse
- Entering hemodialysis due to current psychotropic drug use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation
The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment.
The main question[s] it aims to answer are:
Do consciously applied nursing interventions increase the psychosocial adjustment to the disease in hemodialysis patients? Do mindfulness-based nursing interventions increase body and mind awareness in hemodialysis patients? Researchers will compare the experimental and control groups to see if mindfulness-based interventions have an effect on the psycho-social adjustment of hemodialysis patients.
Read the detailed description
Primary Aims Test the efficacy of an adapted Mindfulness-Based Stress Reduction program to reduce symptoms and improve psychosocial adaption by 6 weeks.
Hypotheses
Primary: The mindfulness-based program increases the psychosocial adjustment to the disease in hemodialysis patients.
Secondary: Mindfulness-based program increases body and mind awareness in hemodialysis patients.
Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide psychosocial adaptation relief to hemodialysis patients and are safe, practical, and cost-effective.
Interventions: The Mindfulness-based Applied program includes the curricular content of the standard 6 week. A trained teacher provides instruction in meditation techniques, including body scan, standing, sitting, and walking meditations, and mindful yoga.
The attention control consists of 90-minute online workshops. Audio recordings and written materials related to awareness exercises will be given to the participants at the end of each session so that they can do home practices.
Recruiting Methods:
It will consist of hemodialysis patients receiving service from hemodialysis centers located in a province in the west of Turkey. The sample of the study will consist of individuals who voluntarily agree to participate in the study and who comply with the research criteria.
Data Collection Tools Mindfulness scale: Mindful Awareness Attention Scale (MAAS) The psychosocial adjustment to illness scale (PAIS-SR) Hemodialysis Stressor Scale (HSS)
Study Design: Randomized controlled experimental study
- Conditions
- Hemodialysis, Psychosocial Adaptation
- Being tested
- Mindfulness-based Applied, Active Comparator: Control groups
- Keywords
- Mindfulness, Hemodialysis, Nursing, Psychosocial Adaptation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based AppliedBehavioural
Mindfulness-Based Practices is planned to be an 8-week program of mindfulness meditation and gentle Hatha yoga taught in an online class for up to 14 participants.
Active Comparator: Control groupsBehavioural
No intervention will be made in this group.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based Applied | Experimental | Patients in the experimental group were determined, 6-week, 90-minute-a-week mindfulness-based nursing interventions were taught, and group applications were made before the intervention and after; pre-test and post-test questionnaires were applied. Receives: Behavioral: Mindfulness-based Applied |
| Control groups | Active comparator | No intervention was made in the control group. At the start of the intervention step of the study and after six weeks, pre-test and post-test questionnaires were applied to control groups. Receives: Behavioral: Active Comparator: Control groups |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mindfulness-Based Practice Applied to Hemodialysis Patients
Awareness-Based Practice Applied to Haemodialysis Patients is expected to affect the psychosocial adaptation of patients to their diseases.. Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR) was used to assess this outcome measure. Each item is scored on a scale ranging from 0 to 3. Largely negative differences since the disease are evaluated with a score of 3 and positive differences with a score of 0. In studies conducted with PAIS-SR, scores lower than 35 are evaluated as good psychosocial adjustment, scores between 35-51 as moderately good psychosocial adjustment, and scores higher than 51 as poor adjustment.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2024
- Study start1 Jul 2022
- Primary completion1 Jan 2024
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HemodialysisStudies of the same condition, open and under way.
- More trials run by Sakarya UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sakarya University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, GÜLGÜNDURAT, Sakarya University
- Investigators
- Çiğdem Şen Tepe, MSc, Principal investigator, Sakarya University Faculty of Healt ScienceGülgün Durat, Assoc. Prof., Study director, Sakarya University Faculty of Healt Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06404957
- Sponsor's protocol ID
- SakaryaU-Hemodialysis
- Acronym
- EMBAHPPA
- Status last verified
- May 2024
- First submitted
- 22 Dec 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sohn BK, Oh YK, Choi JS, Song J, Lim A, Lee JP, An JN, Choi HJ, Hwang JY, Jung HY, Lee JY, Lim CS. Effectiveness of group cognitive behavioral therapy with mindfulness in end-stage renal disease hemodialysis patients. Kidney Res Clin Pract. 2018 Mar;37(1):77-84. doi: 10.23876/j.krcp.2018.37.1.77. Epub 2018 Mar 31.
PubMed 29629280Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
PubMed 15256293Gross CR, Reilly-Spong M, Park T, Zhao R, Gurvich OV, Ibrahim HN. Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation. Contemp Clin Trials. 2017 Jun;57:37-43. doi: 10.1016/j.cct.2017.03.014. Epub 2017 Mar 22.
PubMed 28342990
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation
- ClinicalTrials.gov ID
- NCT06404957
- Acronym / sponsor ID
- EMBAHPPA / SakaryaU-Hemodialysis
- Conditions
- Hemodialysis, Psychosocial Adaptation
- Keywords
- Mindfulness, Hemodialysis, Nursing, Psychosocial Adaptation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Sakarya UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2024 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 8 May 2024 (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.
The goal of this clinical study is to adapt mindfulness-based nursing interventions to hemodialysis patients and to investigate their effects on their psychosocial adjustment.
The main question[s] it aims to answer are:
Do consciously applied nursing interventions increase the psychosocial adjustment to the disease in hemodialysis patients? Do mindfulness-based nursing interventions increase body and mind awareness in hemodialysis patients? Researchers will compare the experimental and control groups to see if mindfulness-based interventions have an effect on the psycho-social adjustment of hemodialysis patients.
Detailed description
Primary Aims Test the efficacy of an adapted Mindfulness-Based Stress Reduction program to reduce symptoms and improve psychosocial adaption by 6 weeks.
Hypotheses
Primary: The mindfulness-based program increases the psychosocial adjustment to the disease in hemodialysis patients.
Secondary: Mindfulness-based program increases body and mind awareness in hemodialysis patients.
Long-range Goal: To develop evidence-based recommendations for non-pharmacologic strategies that provide psychosocial adaptation relief to hemodialysis patients and are safe, practical, and cost-effective.
Interventions: The Mindfulness-based Applied program includes the curricular content of the standard 6 week. A trained teacher provides instruction in meditation techniques, including body scan, standing, sitting, and walking meditations, and mindful yoga.
The attention control consists of 90-minute online workshops. Audio recordings and written materials related to awareness exercises will be given to the participants at the end of each session so that they can do home practices.
Recruiting Methods:
It will consist of hemodialysis patients receiving service from hemodialysis centers located in a province in the west of Turkey. The sample of the study will consist of individuals who voluntarily agree to participate in the study and who comply with the research criteria.
Data Collection Tools Mindfulness scale: Mindful Awareness Attention Scale (MAAS) The psychosocial adjustment to illness scale (PAIS-SR) Hemodialysis Stressor Scale (HSS)
Study Design: Randomized controlled experimental study
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental study
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based Applied | Experimental | Behavioral: Mindfulness-based AppliedPatients in the experimental group were determined, 6-week, 90-minute-a-week mindfulness-based nursing interventions were taught, and group applications were made before the intervention and after; pre-test and post-test questionnaires were applied. |
| Control groups | Active comparator | Behavioral: Active Comparator: Control groupsNo intervention was made in the control group. At the start of the intervention step of the study and after six weeks, pre-test and post-test questionnaires were applied to control groups. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Receiving hemodialysis treatment
- Between the ages of 18-65
Key exclusion criteria (5 listed)
- Patients with acute renal failure
- Current hospitalization, current ongoing chemotherapy or radiotherapy
- Cognitive dysfunction or mental retardation
- Current substance abuse
- Entering hemodialysis due to current psychotropic drug use
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 |
|---|---|---|
| Mindfulness-based AppliedMindfulness-Based Practices is planned to be an 8-week program of mindfulness meditation and gentle Hatha yoga taught in an online class for up to 14 participants. | Behavioural | Mindfulness-based Applied |
| Active Comparator: Control groupsNo intervention will be made in this group. | Behavioural | Control groups |
Primary outcome
Mindfulness-Based Practice Applied to Hemodialysis Patients
Time frame: 6 weeks
Awareness-Based Practice Applied to Haemodialysis Patients is expected to affect the psychosocial adaptation of patients to their diseases.. Psychosocial Adjustment to Illness Self-Report Scale (PAIS-SR) was used to assess this outcome measure. Each item is scored on a scale ranging from 0 to 3. Largely negative differences since the disease are evaluated with a score of 3 and positive differences with a score of 0. In studies conducted with PAIS-SR, scores lower than 35 are evaluated as good psychosocial adjustment, scores between 35-51 as moderately good psychosocial adjustment, and scores higher than 51 as poor adjustment.
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 8 May 2024.
- Background: PubMed 29629280Sohn BK, Oh YK, Choi JS, Song J, Lim A, Lee JP, An JN, Choi HJ, Hwang JY, Jung HY, Lee JY, Lim CS. Effectiveness of group cognitive behavioral therapy with mindfulness in end-stage renal disease hemodialysis patients. Kidney Res Clin Pract. 2018 Mar;37(1):77-84. doi: 10.23876/j.krcp.2018.37.1.77. Epub 2018 Mar 31.
- Background: PubMed 15256293Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. doi: 10.1016/S0022-3999(03)00573-7.
- Background: PubMed 28342990Gross CR, Reilly-Spong M, Park T, Zhao R, Gurvich OV, Ibrahim HN. Telephone-adapted Mindfulness-based Stress Reduction (tMBSR) for patients awaiting kidney transplantation. Contemp Clin Trials. 2017 Jun;57:37-43. doi: 10.1016/j.cct.2017.03.014. Epub 2017 Mar 22.
- Turkish Society of Nephrology Registry 2019Link provided by the sponsor.
- 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.
Çiğdem Şen Tepe, MSc principal investigator
Sakarya University Faculty of Healt Science
Gülgün Durat, Assoc. Prof. study director
Sakarya University Faculty of Healt Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Applied in people with Hemodialysis and Psychosocial Adaptation, run by Sakarya University at 1 site in Turkey (Türkiye).
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 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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. 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?
Mindfulness-Based Practice Applied to Hemodialysis Patients (time frame: 6 weeks). 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 NCT06404957, which also lists 3 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 8 May 2024.