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

NCT06404957 | Completed DMC

• 1 other identifier: SakaryaU-Hemodialysis
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis; Psychosocial Adaptation

Keywords

Mindfulness; Hemodialysis; Nursing; Psychosocial Adaptation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Mindfulness-based Applied

EXPERIMENTAL

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

Control groups

ACTIVE COMPARATOR

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

Interventions

Mindfulness-based Applied BEHAVIORAL

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.

Mindfulness-based Applied

Active Comparator: Control groups BEHAVIORAL

No intervention will be made in this group.

Control groups

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sakarya University: lead

Study Sites (1)

Çiğdem Şen Tepe

Sakarya, 54050, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 29629280 BACKGROUND

• 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.

  PMID: 15256293 BACKGROUND

• 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.

  PMID: 28342990 BACKGROUND

Related Links

• Turkish Society of Nephrology Registry 2019

Study Officials

• Çiğdem Şen Tepe, MSc

  Sakarya University Faculty of Healt Science

  PRINCIPAL INVESTIGATOR

• Gülgün Durat, Assoc. Prof.

  Sakarya University Faculty of Healt Science

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: Randomized controlled experimental study

Study Record Dates

• First Submitted: December 22, 2022
• First Posted: May 8, 2024
• Study Start: July 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)