Clinical trial NCT05665959: Reiki Effects on Pain, Functional Status and Holistic Well-Being in Patients With Knee Osteoarthritis
Official title: The Effect of Reiki Therapy on Pain, Functional Status and Holistic Well-being in Patients With Knee Osteoarthritis: A Randomized Controlled Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Knee Osteoarthritis
Pain
Keywords: Reiki
functional status
pain
knee osteoarthritis
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 42
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients were included who has grade 2 or three knee osteoarthritis.

Brief summary: This study aimed to examine the effect of Reiki therapy on pain, functional status and holistic well-being in patients with knee osteoarthritis.

Detailed description: Knee osteoarthritis is a chronic degenerative joint disease that causes pain in individuals and negatively affects their functional status and overall well-being. Patients often benefit from non-pharmacological methods in pain control. Reiki, expressed as "universal life energy", is a kind of energy therapy that creates the appropriate conditions required by the body's natural healing system in rebalancing and recharging human energy fields. Although Reiki studies in the field of orthopedics are limited, it is revealed that Reiki improves physical function, reduces fatigue and increases emotional well-being in rheumatoid arthritis patients. Studies evaluating the effectiveness of Reiki in patients undergoing total knee replacement have evaluated that Reiki is effective in controlling postoperative pain, reducing blood pressure, respiratory rate, and state anxiety.

The study was conducted with patients with knee osteoarthritis who applied to the orthopedic outpatient clinic of a training and research hospital between June 24, 2022 and December 31, 2022. The data of the study was collected using "Patient Information Form (PIF)", "Visual Analog Scale (VAS)", "Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)" and "Holistic Well-Being Scale (HWS).

PIF, VAS, WOMAC and HWS were applied to the patients who met the inclusion criteria and agreed to participate in the study. Patients were randomized 1:1 into groups by a single therapist according to the block randomization method. There were two arms in the study; Reiki treatment (n=21) and control group (n=21). A second-degree Reiki practitioner applied Reiki to the patients for 40 minutes. On the second day and the third day, 30 minutes distant Reiki were applied to the patients. In the control group, nothing was done. Post-tests were applied to all patients 3 days and 10 days after they were included in the study.

Eligibility criteria: Inclusion Criteria:

* Grade 2-3 osteoarthritis according to the Kellgren Lawrence scale,
* Patients aged 40 and over

Exclusion Criteria:

* Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish,
* Those who refuse to answer the Reiki application and data collection tools,
* Those who want to leave at any stage of the research or cannot be reached by phone,
* Those who underwent an application such as physical therapy, intraarticular injection or prolotherapy during the research process,
* Those who used any Complementary and Alternative Method (CAM) in the last 6 months were excluded from the study.

Primary outcomes:
measure: Personal Information Form
timeFrame: Baseline
measure: Visual Analog Scale
timeFrame: Change from baseline Visual Analog Scale at 3 days and 10 days
measure: Western Ontario and McMaster Universities Osteoarthritis Index
timeFrame: Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index at 3 days and 10 days
measure: Holistic Well-Being Scale
timeFrame: Change from baseline Holistic Well-Being Scale at 3 days and 10 days
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nursemin Ünal
state: None Selected
Study officials:
affiliation: Ankara Medipol University
name: Nursemin Unal
role: PRINCIPAL_INVESTIGATOR
References:
citation: McConnell S, Kolopack P, Davis AM. The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): a review of its utility and measurement properties. Arthritis Rheum. 2001 Oct;45(5):453-61. doi: 10.1002/1529-0131(200110)45:53.0.co;2-w. No abstract available.
citation: Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual Analog Scale for Pain (VAS Pain), Numeric Rating Scale for Pain (NRS Pain), McGill Pain Questionnaire (MPQ), Short-Form McGill Pain Questionnaire (SF-MPQ), Chronic Pain Grade Scale (CPGS), Short Form-36 Bodily Pain Scale (SF-36 BPS), and Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP). Arthritis Care Res (Hoboken). 2011 Nov;63 Suppl 11:S240-52. doi: 10.1002/acr.20543. No abstract available.
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citation: Notte BB, Fazzini C, Mooney RA. Reiki's effect on patients with total knee arthroplasty: A pilot study. Nursing. 2016 Feb;46(2):17-23. doi: 10.1097/01.NURSE.0000476246.16717.65.
citation: Topdemir EA, Saritas S. The effect of Acupressure and Reiki application on Patient's pain and comfort level after laparoscopic cholecystectomy: A randomized controlled trial. Complement Ther Clin Pract. 2021 May;43:101385. doi: 10.1016/j.ctcp.2021.101385. Epub 2021 Apr 2.
citation: Bannuru RR, Osani MC, Vaysbrot EE, Arden NK, Bennell K, Bierma-Zeinstra SMA, Kraus VB, Lohmander LS, Abbott JH, Bhandari M, Blanco FJ, Espinosa R, Haugen IK, Lin J, Mandl LA, Moilanen E, Nakamura N, Snyder-Mackler L, Trojian T, Underwood M, McAlindon TE. OARSI guidelines for the non-surgical management of knee, hip, and polyarticular osteoarthritis. Osteoarthritis Cartilage. 2019 Nov;27(11):1578-1589. doi: 10.1016/j.joca.2019.06.011. Epub 2019 Jul 3.