NCT05861934

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 17, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2024

Completed
Last Updated

August 6, 2024

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

March 24, 2023

Last Update Submit

August 5, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

    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).

    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).

    6 weeks

Study Arms (2)

Distant reiki group

EXPERIMENTAL

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

Behavioral: Distant reiki group

Control group

NO INTERVENTION

Control group; routine care and treatment will be applied.

Interventions

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.

Distant reiki group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cemile KÜTMEÇ YILMAZ

Merkez, Aksaray, 68100, Turkey (Türkiye)

Location

Aksaray University Health Science Faculty

Aksaray, 68100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 24, 2023

First Posted

May 17, 2023

Study Start

November 20, 2022

Primary Completion

September 20, 2023

Study Completion

July 20, 2024

Last Updated

August 6, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations