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Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation

The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06404957
Acronym
EMBAHPPA
Enrollment
32
Registered
2024-05-08
Start date
2022-07-01
Completion date
2024-01-01
Last updated
2024-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis, Psychosocial Adaptation

Keywords

Mindfulness, Hemodialysis, Nursing, Psychosocial Adaptation

Brief 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 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

Interventions

BEHAVIORALMindfulness-based Applied

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.

BEHAVIORALActive Comparator: Control groups

No intervention will be made in this group.

Sponsors

Sakarya University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Intervention model description

Randomized controlled experimental study

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Receiving hemodialysis treatment * Between the ages of 18-65

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Mindfulness-Based Practice Applied to Hemodialysis Patients6 weeksAwareness-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.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026