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

Hemodialysis Clinical Trial

— EMBAHPPA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06404957
• Other study ID #: SakaryaU-Hemodialysis
• Status: Completed
• Phase: N/A
• Start date: July 1, 2022
• Est. completion date: January 1, 2024

Study information

• Verified date: May 2024
• Source: Sakarya University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Behavioral:
• Mindfulness-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.
• Active Comparator: Control groups
No intervention will be made in this group.

Locations

Country	Name	City	State
Turkey	Çigdem Sen Tepe	Sakarya

Sponsors (1)

Lead Sponsor	Collaborator
Sakarya University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Gross 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. — View Citation

Grossman 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	6 weeks

External Links

•   Turkish Society of Nephrology Registry 2019