NCT05531175

Brief Summary

The research sample consisted of 74 individuals, including the intervention group (n=37) and the control group (n=37), who received hemodialysis treatment at Sivas Cumhuriyet University Application and Research Hospital Hemodialysis Unit, Sivas Numune Hospital Hemodialysis Unit and Private ONR Dialysis Center. The data of the study were collected using the Patient Description Form, the Patient Clinical Parameters Form (Some Treatment Data and Laboratory Results, Measurement of Pain Intensity), Visual Analogue Scale (VAS), McGill Melzack Pain Questionnaire, Piper Fatigue Scale, and 5-D Itch Scale. A total of 10 sessions of reiki were applied to the patients in the intervention group twice a week for 5 weeks, lasting 40-45 minutes during dialysis. No treatment was applied to the control group. The scales were administered to the individuals in the intervention and control groups three times in total.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

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

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2021

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2021

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

August 27, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
Last Updated

September 7, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

August 27, 2022

Last Update Submit

September 5, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • Pain Status Visual Analog Scale Visual analog scale and A short form of the McGill Pain Questionnaire

    It is a scale used to evaluate the pain experienced by patients. It is a scale used to evaluate the pain experienced by patients. Hastaların yaşadığı ağrıyı değerlendirmek için kullanılan bir ölçektir. It is a scale that is used to evaluate the pain experienced by patients. Hastaların yaşadığı ağrıyı değerlendirmek için kullanılan bir ölçektir. Scale; It contains the numbers "starting 0 (no pain)" and "10 (severe pain)" at the other end.

    Pain assessment was made at the first interview (basaline), in the second week of the reiki application, and in the fifth week of the reiki application. Changes in the pain level of the patients were observed.

  • Pain Status A short form of the McGill Pain Questionnaire Visual analog scale and A short form of the McGill Pain Questionnaire

    The McGill Melzack Pain Questionnaire (MASF) was developed in 1971 by Melzack and Targerson. It consists of three parts evaluating pain pattern, current pain index, and pain scale score.

    Pain assessment was made at the first interview (basaline), in the second week of the reiki application, and in the fifth week of the reiki application. Changes in the pain level of the patients were observed.

  • Piper Fatigue Scale

    The scale was developed by Piper et al. in 1998. The scale, which subjectively evaluates the patient's fatigue in four dimensions, consists of 27 items in total. The sub-dimensions of the scale, the behavior/violence sub-dimension (2-7 items); affect sub-dimension (items 8-12), which includes the emotional meaning of fatigue; it is the sensory sub-dimension (13-17 items) showing the physical, psychological and emotional symptoms of fatigue, and the cognitive/spiritual sub-dimension (18-23 items) showing the effect of fatigue on cognitive and mental state. The total score is obtained by adding each item and dividing it by the number of items.

    Fatigue assessment was made at the first interview (basaline), in the second week of the reiki application, and in the fifth week of the reiki application. Changes in the fatigue level of the patients were observed.

  • 5-D Itch Scale

    The 5-D Itch Scale was developed by Elman, Hyman, Gabriel and Mayo in 2010. The scale consists of 5 dimensions and 8 variables as the duration, severity, course of itching, the area of restriction in activities of daily living and its distribution in the body. The scale is scored between a minimum of 5 (no itching) and a maximum of 25 points.

    Itching assessment was made at the first interview (basaline), in the second week of the reiki application, and in the fifth week of the reiki application. Changes in the itching level of the patients were observed.

Study Arms (2)

İntervention Group

EXPERIMENTAL

A total of 10 sessions of reiki were applied to the patients in the intervention group twice a week for 5 weeks, lasting 40-45 minutes during dialysis. The scales were administered to the individuals in the intervention groups three times in total.

Other: Reiki apply

Control Group

NO INTERVENTION

No treatment was applied to the control group. The scales were administered to the individuals in the control groups three times in total.

Interventions

The intervention group is the group in which reiki is applied. They receives 3 sessions of hemodialysis per week.

İntervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The research sample consisted of patients who had no difficulties in communicating and had no mental problems, who had undergone hemodialysis treatment for at least one year, who were 18 years of age or older and who agreed to participate in the study, who did not receive complementary alternative treatment for symptom management, and who experienced symptoms of fatigue, itching and pain.

You may not qualify if:

  • Those younger than 18 years of age, those receiving hemodialysis treatment for less than a year, those with communication difficulties, those with psychiatric problems, and those who wanted to leave the study were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra BAŞER AKIN

Sivas, 58000, Turkey (Türkiye)

Location

Related Publications (1)

  • Baser Akin E, Mollaoglu M. Investigation of the Effect of Reiki on Pain, Fatigue, and Itching in Hemodialysis Patients: Randomized Controlled Trial. Hemodial Int. 2025 Apr;29(2):201-213. doi: 10.1111/hdi.13203. Epub 2025 Feb 5.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Asisstant

Study Record Dates

First Submitted

August 27, 2022

First Posted

September 7, 2022

Study Start

September 1, 2020

Primary Completion

April 25, 2021

Study Completion

May 22, 2021

Last Updated

September 7, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will share

PhD thesis submission exam

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
22 September 2022

Locations