Clinical trial NCT06404957: Effect of Mindfulness-based Applied to Hemodialysis Patients on Psychosocial Adaptation
Official title: The Effect of Mindfulness-based Nursing Interventions Applied to Hemodialysis Patients on Psychosocial Adaptation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemodialysis
Psychosocial Adaptation
Keywords: Mindfulness
Hemodialysis
Nursing
Psychosocial Adaptation
Lead sponsor: Sakarya University
Sponsor class: OTHER
First posted: 2024-05-08
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled experimental study
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Eligibility criteria: 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

Primary outcomes:
measure: Mindfulness-Based Practice Applied to Hemodialysis Patients
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sakarya
country: Turkey
facility: Çiğdem Şen Tepe
Study officials:
affiliation: Sakarya University Faculty of Healt Science
name: Çiğdem Şen Tepe, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Sakarya University Faculty of Healt Science
name: Gülgün Durat, Assoc. Prof.
role: STUDY_DIRECTOR
References:
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.
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.
citation: 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.