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

Not Applicable

Completed

• Conditions: Hemodialysis; Psychosocial Adaptation
• Interventions: Behavioral: Mindfulness-based Applied

• Registration Number: NCT06404957
• Lead Sponsor: Sakarya University

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

Study Timeline

• Study Start: 2022-07-01
• Study First Submitted: 2022-12-22
• Primary Completion: 2024-01-01
• Study Completion: 2024-01-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-04
• Last Update Submitted: 2024-05-04
• Study First Posted: 2024-05-08
• Last Update Posted: 2024-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness-based Applied	Mindfulness-based Applied	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.

Primary Outcome Measures

Name	Time	Method
Mindfulness-Based Practice Applied to Hemodialysis Patients	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.

Trial Locations

Locations (1)

Çiğdem Şen Tepe; 🇹🇷 Sakarya, Turkey