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The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality

Primary Purpose

Rheumatoid Arthritis

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Distant reiki group
Sponsored by
Aksaray University Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Cemile KÜTMEÇ YILMAZ
  • Aksaray University Health Science FacultyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Distant reiki group

Control group

Arm Description

To examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.

Control group; routine care and treatment will be applied.

Outcomes

Primary Outcome Measures

Distant Reiki application changes the level of pain in rheumatoid arthritis patients.
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).
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.
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).
Distant Reiki application changes sleep quality in rheumatoid arthritis patients. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
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).

Secondary Outcome Measures

Full Information

First Posted
March 24, 2023
Last Updated
May 7, 2023
Sponsor
Aksaray University Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05861934
Brief Title
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality
Official Title
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality in Rheumatoid Arthritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
June 20, 2023 (Anticipated)
Study Completion Date
July 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aksaray University Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Distant reiki group
Arm Type
Experimental
Arm Description
To examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Control group; routine care and treatment will be applied.
Intervention Type
Behavioral
Intervention Name(s)
Distant reiki group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Distant Reiki application changes the level of pain in rheumatoid arthritis patients.
Description
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).
Time Frame
6 weeks
Title
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.
Description
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).
Time Frame
6 weeks
Title
Distant Reiki application changes sleep quality in rheumatoid arthritis patients. Sleep quality will be assessed using the Pittsburgh Sleep Quality Index.
Description
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).
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Cemile KÜTMEÇ YILMAZ
City
Merkez
State/Province
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
3822882771
Email
cemilekutmec@yahoo.com
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
03822882784
Email
cemilekutmec@yahoo.com
Facility Name
Aksaray University Health Science Faculty
City
Aksaray
ZIP/Postal Code
68100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cemile K YILMAZ
Phone
0382288
Ext
2784
Email
cemilekutmec@yahoo.com
Phone
0382288
Ext
2785

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality

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