- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07394660
The Effect of Remote Reiki Treatment on Hopelessness, Fatigue and Pain in Patients Awaiting Organ Transplantation
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yozgat
-
Yozgat, Yozgat, Turkey (Türkiye), 66100
- Gökmedrese Dialasis Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients who have been undergoing haemodialysis for ≥ 6 months,
- Aged 18 years or older,
- Patients with chronic kidney disease,
- Can speak and understand Turkish and,
- Have a mobile phone and can use it will be included in the study.
Exclusion Criteria:
- Patients using psychotropic medication will not be included in the study.
- Patients who are unable to attend regular sessions will be excluded from the study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: 2
control
|
|
|
Experimental: 1
remote reiki
|
Patients in the intervention group will be contacted by telephone.
They will be provided with a suitable environment.
A certified assistant researcher will initiate the remote Reiki application.
Each application is expected to last an average of 35-40 minutes.
The first remote Reiki session will be conducted on the evening of the patient's haemodialysis day.
The sessions will take place three times a week for a total of four weeks.
After the application is completed, vital signs will be taken again from the intervention group patients, and the Beck Hopelessness Scale, Fatigue Severity Scale, and Brief Pain Inventory will be completed.
The data collection tool will be completed a second time the day after the last application and a third time one month later.
The effects of Reiki therapy on hopelessness, fatigue, and pain will be evaluated using the Personal Information Form, Beck Hopelessness Scale, Fatigue Severity Scale, and Brief Pain Inventory.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Hopelessness Level
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Hopelessness level will be assessed using the Beck Hopelessness Scale (BHS).
The scale consists of 20 items and measures negative expectations about the future.
Higher total scores indicate greater levels of hopelessness.
Total scale score (0-20) Unit of Measure: Scale total score (0-20)
|
From enrollment to the end of treatment at 8 weeks
|
|
Pain Intensity and Pain Interference
Time Frame: From enrollment to the end of treatment at 8 weeks
|
Pain intensity and pain-related interference with daily activities will be assessed using the numeric raito scale (NRS).
The instrument evaluates pain severity and its impact on functioning.
Pain severity score and pain interference score Unit of Measure: Scale total score (0-10)
|
From enrollment to the end of treatment at 8 weeks
|
|
Fatigue Severity
Time Frame: Baseline (first dialysis day), at 4 weeks (end of intervention), and 1 month after the final intervention session
|
Fatigue severity will be measured using the Fatigue Severity Scale (FSS), a 9-item self-report questionnaire evaluating the impact of fatigue on daily functioning. Higher scores indicate greater fatigue severity. Unit of Measure: Total scale score (1-7) |
Baseline (first dialysis day), at 4 weeks (end of intervention), and 1 month after the final intervention session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic Blood Pressure
Time Frame: Baseline to 8 weeks
|
Description: Systolic blood pressure measured under standardized resting conditions using an automated monitor. Unit of Measure: mmHg |
Baseline to 8 weeks
|
|
Diastolic Blood Pressure
Time Frame: Baseline to 8 weeks
|
Description: Diastolic blood pressure measured under standardized resting conditions using an automated monitor. Unit of Measure: mmHg |
Baseline to 8 weeks
|
|
Heart Rate
Time Frame: Baseline to 8 weeks
|
Description: Resting heart rate measured using an automated vital signs monitor. Unit of Measure: beats per minute (bpm) |
Baseline to 8 weeks
|
|
Body Temperature
Time Frame: Baseline to 8 weeks
|
Description: Body temperature measured using a digital thermometer under standardized conditions. Unit of Measure: °C |
Baseline to 8 weeks
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Akpinar, N. B., Unal, N., Alıncak, G., Pörücü, C., Yurtsever, S., & Karadurmus, N. (2025). The Power of Reiki: Its Effects on Pain and Biochemical Parameters in Patients Undergoing Bone Marrow Transplantation: A Randomized Prospective Controlled Study. Pain Management Nursing, 26(1), e24-e30.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BozokUnıversity
- the author himself (Other Identifier: the author himself)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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