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REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS

Primary Purpose

Hemodialysis Complication

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reiki apply
Sponsored by
Cumhuriyet University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hemodialysis Complication

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Esra BAŞER AKIN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

İntervention Group

Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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 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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
August 27, 2022
Last Updated
September 5, 2022
Sponsor
Cumhuriyet University
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1. Study Identification

Unique Protocol Identification Number
NCT05531175
Brief Title
REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS
Official Title
INVESTIGATION OF THE EFFECT OF REIKI APPLICATION ON PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
April 25, 2021 (Actual)
Study Completion Date
May 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cumhuriyet University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodialysis Complication

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
İntervention Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
No treatment was applied to the control group. The scales were administered to the individuals in the control groups three times in total.
Intervention Type
Other
Intervention Name(s)
Reiki apply
Intervention Description
The intervention group is the group in which reiki is applied. They receives 3 sessions of hemodialysis per week.
Primary Outcome Measure Information:
Title
Pain Status Visual Analog Scale Visual analog scale and A short form of the McGill Pain Questionnaire
Description
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.
Time Frame
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.
Title
Pain Status A short form of the McGill Pain Questionnaire Visual analog scale and A short form of the McGill Pain Questionnaire
Description
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.
Time Frame
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.
Title
Piper Fatigue Scale
Description
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.
Time Frame
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.
Title
5-D Itch Scale
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Esra BAŞER AKIN
City
Sivas
ZIP/Postal Code
58000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
PhD thesis submission exam
IPD Sharing Time Frame
22 September 2022

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REIKI APPLICATION PAIN, FATIGUE AND ITCHING IN HEMODIALYSIS PATIENTS

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