NCT06063616

Brief Summary

Purpose The purpose of this study is to determine the effect of Reiki on pain intensity and quality of life in patients receiving hemodialysis treatment. Materials and methods The research was conducted as a qualitative study using pretest-posttest, double-blind, randomized controlled study and semi-structured in-depth interview. In this study, patients receiving HD treatment in three separate private dialysis centers in Turkey were randomized to Reiki and sham Reiki groups. In the first three hours of the HD session, in the first three hours of the HD session, three sessions a week for a total of 12 sessions for 30 minutes (min), the first level is applied to 9 main points (crown, forehead, throat, heart, solar plexus, sacral and root chakras, knees, ankles and feet). While applying Reiki, the sham Reiki group was touched at the same points for the same period of time by the uninitiated practitioner. At the beginning and end of the study, Kidney Disease Quality of Life (KDQOLTM-36) scores, Visual Analogue Scale (VAS-Pain) before and after the application, and psychodynamic reactions experienced during the Reiki application after the application were evaluated. At the end of the research, the Reiki group's opinions about the Reiki experience were collected using a form consisting of semi-structured questions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 6, 2022

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 4, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 8, 2022

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 12, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 2, 2023

Completed
Last Updated

January 9, 2025

Status Verified

March 1, 2022

Enrollment Period

28 days

First QC Date

September 12, 2023

Last Update Submit

January 8, 2025

Conditions

Keywords

HemodialysisReikiPainQuality of lifeNursing

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Pain severity measurement at the end of the 12th session

    4 weeks later

  • Quality of life measurement at the end of the 12th session

    4 weeks later

Study Arms (2)

Reiki group

EXPERIMENTAL

Level I Reiki was applied to 9 points and nearby areas for 30 minutes, three sessions a week, for a total of four weeks, in the first three hours of the HD treatment, by the researcher who completed his second level training according to the Usui method, in line with the Reiki/Sham Reiki Application Protocol.

Other: Reiki

Sham Reiki group

SHAM COMPARATOR

Sham Reiki was applied to 9 points and nearby areas in accordance with the Reiki/Sham Reiki Application Protocol, for a total of four weeks, three sessions per week, for 30 minutes, in the first three hours of the HD treatment, by two students who had not received Reiki training, and were given training on the application by the researcher.

Other: Sham Reiki

Interventions

ReikiOTHER

Level I Reiki was applied to 9 points and nearby areas for 30 minutes, three sessions a week, for a total of four weeks, in the first three hours of the HD treatment, by the researcher, who completed his second level training according to the Usui method, in line with the Reiki/Sham Reiki Application Protocol.

Reiki group

Sham Reiki was applied to 9 points and nearby areas in accordance with the Reiki/Sham Reiki Application Protocol, for a total of four weeks, three sessions per week, for 30 minutes, in the first three hours of the HD treatment, by two students who had not received Reiki training, and were given training on the application by the researcher.

Sham Reiki group

Eligibility Criteria

Age26 Years - 82 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who are 18 years of age and over,
  • Able to speak Turkish and have no communication problems,
  • Receiving HD treatment three times a week for 6 months or longer,
  • Without a pacemaker,
  • Pain intensity of 4 or more based on the average of two VAS-Pain measurement values evaluated one week apart,
  • Having lower extremity pain,
  • Does not have any psychiatric disorder,
  • Patients over the age of 65 with a Standardized Mini Mental Test (SMMT) score of 24 points and above were included.

You may not qualify if:

  • Those who are under 18 years of age,
  • Having hearing problems,
  • Those who do not speak Turkish and cannot communicate,
  • Having a pacemaker installed,
  • Pain intensity of 3 or less according to the average of two VAS-Pain measurement values evaluated one week apart,
  • No lower extremity pain,
  • Having any psychiatric disorder,
  • Those who have previously received energy-based therapies such as Reiki/therapeutic touch/healing touch,
  • Patients over the age of 65 with an SMMT value below 24 were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sultan Çeçen

Çorum, 19030, Turkey (Türkiye)

Location

Related Publications (1)

  • Zins S, Hooke MC, Gross CR. Reiki for Pain During Hemodialysis: A Feasibility and Instrument Evaluation Study. J Holist Nurs. 2019 Jun;37(2):148-162. doi: 10.1177/0898010118797195. Epub 2018 Aug 31.

    PMID: 30170509BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The two interviewers responsible for data collection and the patients were blinded as to which group they were in. According to the lists created after block randomization in the computer environment, the researcher and the sham Reiki practitioner evaluated the individuals in the groups in which they would apply and received written consent from those who agreed to participate in the research. It was stated that Reiki treatment would be applied to the patients in both groups and the patients were blinded. The group of patients who agreed to participate in the study was not written on the data collection forms until the end of the study. In addition, the interviewer who collected the data was blinded by ensuring that he did not enter the HD hall before the applications were completed.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

September 12, 2023

First Posted

October 2, 2023

Study Start

June 6, 2022

Primary Completion

July 4, 2022

Study Completion

September 8, 2022

Last Updated

January 9, 2025

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

De-identified individual participation data will be made available for all outcome measures.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE

Locations