An interventional study of Mindfulness-based Applied and Active Comparator: Control groups in Hemodialysis and Psychosocial Adaptation, sponsored by Sakarya University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by Sakarya University · Not applicable, Interventional, and Health services research
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.
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
Sakarya University is the lead sponsor of 178 studies on the registry; 48 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Behavioral: Mindfulness-based Applied
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.
Behavioral: Active Comparator: Control groups
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.
No intervention will be made in this group.
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.
Time frame: 6 weeks
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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Sakarya University