Rheumatoid ArthritisNCT05861934
The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality
A study testing Distant reiki group in people with Rheumatoid Arthritis, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Distant reiki group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 20 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Aksaray University Health Science Faculty
Aksaray, 68100
Cemile KÜTMEÇ YILMAZ
Merkez, Aksaray, 68100
About this study
Official title: 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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Distant reiki group
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distant reiki groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Distant reiki group | Experimental | To examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients. Receives: Behavioral: Distant reiki group |
| Control group | No intervention | Control group; routine care and treatment will be applied. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2023
- Study start20 Nov 2022
- Primary completion20 Sep 2023
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aksaray University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemile KÜTMEÇ YILMAZ, Aksaray University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05861934
- Sponsor's protocol ID
- 2022/14-02
- Status last verified
- Aug 2024
- First submitted
- 24 Mar 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distant Reiki Application on Pain, Functional Status and Sleep Quality in Rheumatoid Arthritis Patients
- ClinicalTrials.gov ID
- NCT05861934
- Acronym / sponsor ID
- 2022/14-02
- Conditions
- Rheumatoid Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Aksaray University Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 20 Sep 2023 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 17 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distant reiki group | Experimental | Behavioral: Distant reiki groupTo examine the effect of distant reiki application on pain, functional status and sleep quality in rheumatoid arthritis patients. |
| Control group | No intervention | –Control group; routine care and treatment will be applied. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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,
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distant reiki groupccording 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. | Behavioural | Distant reiki group |
Primary outcome
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).
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).
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distant reiki group in people with Rheumatoid Arthritis, run by Aksaray University Training and Research Hospital at 2 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distant Reiki application changes the level of pain in rheumatoid arthritis patients. (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.