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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05531175
Other study ID # 2020-06/24
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2020
Est. completion date May 22, 2021

Study information

Verified date September 2022
Source Cumhuriyet University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 74
Est. completion date May 22, 2021
Est. primary completion date April 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Turkey Esra BASER AKIN Sivas

Sponsors (1)

Lead Sponsor Collaborator
Cumhuriyet University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Hastalarin yasadigi agriyi degerlendirmek için kullanilan bir ölçektir. It is a scale that is used to evaluate the pain experienced by patients. Hastalarin yasadigi agriyi degerlendirmek için kullanilan 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.
Primary 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.
Primary 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.
Primary 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.
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