REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS

INVESTIGATION OF THE EFFECT OF REIKI APPLICATION ON PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS

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.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Other: Reiki apply

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Sivas, Turkey, 58000
    • Esra BAŞER AKIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: İntervention Group; 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; The intervention group is the group in which reiki is applied. They receives 3 sessions of hemodialysis per week.
No Intervention: Control Group; No treatment was applied to the control group. The scales were administered to the individuals in the control groups three times in total.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Cumhuriyet University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Actual): April 25, 2021
• Study Completion (Actual): May 22, 2021

Study Registration Dates

• First Submitted: August 27, 2022
• First Submitted That Met QC Criteria: September 5, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 7, 2022
• Last Update Submitted That Met QC Criteria: September 5, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 2020-06/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: PhD thesis submission exam
• IPD Sharing Time Frame: 22 September 2022
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No