- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05861934
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality
January 30, 2024 updated by: Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality in Rheumatoid Arthritis Patients
Rheumatoid Arthritis (RA) is a chronic, multisystemic, progressive autoimmune disease characterized by joint destruction in synovial tissue, causing joint swelling, pain and morning stiffness.
It is estimated to affect 0.1%-2% of the world's adult population and more women than men.
RA limits individuals' work, social, and home lives and functional capacities.
Patients commonly experience pain and accompanying sleep problems.
Interventions for these problems and symptom management are important.
In this regard, this study was planned to examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Aksaray, Turkey, 68100
- Recruiting
- Aksaray University Health Science Faculty
-
Contact:
- Cemile K YILMAZ
- Phone Number: 2784 0382288
- Email: cemilekutmec@yahoo.com
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Contact:
- Phone Number: 2785 0382288
-
-
Aksaray
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Merkez, Aksaray, Turkey, 68100
- Not yet recruiting
- Cemile KÜTMEÇ YILMAZ
-
Contact:
- Cemile K YILMAZ
- Phone Number: 3822882771
- Email: cemilekutmec@yahoo.com
-
Contact:
- Cemile K YILMAZ
- Phone Number: 03822882784
- Email: cemilekutmec@yahoo.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Being over 18 years old,
- Not having a communication problem,
- Receiving outpatient treatment from the clinic where the research was conducted,
- To have the physical and cognitive competence to answer the data collection forms,
- Not having received body-mind therapy (yoga, reiki, meditation, etc.) in the last six months,
Exclusion Criteria:
- individuals who have done reiki therapy before
- Being under 18 years old,
- Hearing and speaking problems that prevent communication,
- Participating in yoga, reiki, meditation practices in the last 6 months,
- Individuals with cognitive and severe psychiatric problems who cannot answer the survey questions
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control group
Control group; routine care and treatment will be applied.
|
|
Experimental: Distant reiki group
To examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.
|
ccording to Classical Usui Reiki, Reiki II.
Remote Reiki will be practiced twice a week for 6 weeks by researchers who have completed the Phase 2 training.
The time of remote reiki application will be planned by talking with the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Distant Reiki application changes the level of pain in rheumatoid arthritis patients.
Time Frame: 6 weeks
|
Pain level will be assessed using the Visual Analog Scale as a pre-test before starting the distant reiki application and 6 weeks later as a post-test.
(Distant Reiki will be applied for 30 minutes twice a week for 6 weeks).
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6 weeks
|
Distant Reiki application changes the functional status in rheumatoid arthritis patients. Health Assessment Survey will be used to evaluate the functional status of patients in rheumatic diseases.
Time Frame: 6 weeks
|
Functional status will be assessed using the Health Assessment Survey as a pre-test and 6 weeks later as a post-test.
(Distant Reiki will be applied for 30 minutes twice a week for 6 weeks).
|
6 weeks
|
Distant Reiki application changes sleep quality in rheumatoid arthritis patients. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Time Frame: 6 weeks
|
Sleep quality will be assessed using the Pittsburgh Sleep Quality Index as a pre- test and 6 weeks later as a post-test test.
(Distant Reiki will be applied for 30 minutes twice a week for 6 weeks).
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 20, 2022
Primary Completion (Estimated)
April 20, 2024
Study Completion (Estimated)
July 20, 2024
Study Registration Dates
First Submitted
March 24, 2023
First Submitted That Met QC Criteria
May 7, 2023
First Posted (Actual)
May 17, 2023
Study Record Updates
Last Update Posted (Actual)
January 31, 2024
Last Update Submitted That Met QC Criteria
January 30, 2024
Last Verified
January 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/14-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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