The Effect of Second Level Reiki on Pain Severity and Quality of Life in Patients Receiving Hemodialysis Treatment
NCT Number: NCT06519136
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Hemodialysis
Interventions: OTHER: Distance Reiki|OTHER: Sham Reiki
Sponsor: Mersin University
Collaborators: TÜBİTAK
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-08-19
Completion Date: 2025-02-17
Locations: Sultan Çeçen, Çorum, 19030, Turkey

Summary:
Purpose: The aim of this study is to determine the effect of 20-minute second-level Reiki application for 4 consecutive days on pain intensity and quality of life in patients receiving hemodialysis (HD) treatment and It is a comparison of the follow-up results of the first level Reiki applied within the scope of the doctoral thesis and the second level Reiki applications to be applied within the scope of this study.

Method: The study will be conducted as a pre-test-post-test, double-blind, randomized controlled trial. After obtaining Ethical Committee approval, participants in the Reiki group will receive 20-minute Reiki sessions at the second level daily from 7:00 PM to 9:00 PM for four days, while participants in the sham Reiki group will be informed that distant energy application will be performed but no actual treatment will be administered. The researcher will plan to administer second-level Reiki sessions to 8 patients daily. Throughout the study, patients in both groups will continue their routine treatments. At the beginning and three weeks after the end of the intervention, Kidney Disease Quality of Life Scale (KDQOLTM-36) scores will be collected face-to-face at HD centers, before and after the intervention Visual Analog Scale for Pain (VAS-Pain), additionally, psychodynamic responses experienced during the first and last Reiki sessions will be evaluated by three blinded assessors via telephone in both study groups.

Results: Statistical analyses of the data will be conducted using the Statistical Package for Social Sciences (Version 22.0, SPSS Inc., Chicago, IL, USA, License: Hitit University). Depending on the homogeneity of the data distribution, appropriate parametric or nonparametric tests will be performed for data evaluation.

Primary Outcome Measures: Pain severity measurement, "Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score., Day 1|Initial quality of life measurement, Initial quality of life measurement, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life., Day 1
Secondary Outcome Measures: Pain severity measurement at the end of the 4th session, "Visual Analog Scale (VAS-Pain)" was applied to the patients in the Reiki and sham Reiki groups before and after application. In VAS-Pain, 1-3 cm is considered a "mild pain" score, 4-6 cm is considered a "moderate pain" score, and 7-10 cm is considered a "severe pain" score., Day 4|Quality of life measurement at the end of 4 week later, Quality of life measurement at the end of 4 week later, "Kidney Disease Quality of Life -KDQOLTM-36" were applied to the patients in the Reiki and sham Reiki groups. Scores in each subscale of the KDQOLTM-36 scale range from 0 to 100, with higher scores indicating better health-related quality of life., 4 week later