Knee OsteoarthritisNCT05665959
Reiki Effects on Pain, Functional Status and Holistic Well-Being in Patients With Knee Osteoarthritis
An observational study of Knee Osteoarthritis and Pain, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
Trial summary
This study aimed to examine the effect of Reiki therapy on pain, functional status and holistic well-being in patients with knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Knee Osteoarthritis, Pain
- What is being tested?
- Reiki
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Jun 2022to 30 Jan 2023
- How long will I take part?
- 2 Weeks
- Phase
- Observational
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients were included who has grade 2 or three knee osteoarthritis.
Who may be able to join
- Grade 2-3 osteoarthritis according to the Kellgren Lawrence scale,
- Patients aged 40 and over
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Nursemin Ünal
Ankara, None Selected, 06050
Nursemin Unal, 05077433629, nurse_unal@hotmail.com
About this study
Official title: The Effect of Reiki Therapy on Pain, Functional Status and Holistic Well-being in Patients With Knee Osteoarthritis: A Randomized Controlled Study
This study aimed to examine the effect of Reiki therapy on pain, functional status and holistic well-being in patients with knee osteoarthritis.
Read the 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.
- Conditions
- Knee Osteoarthritis, Pain
- Being tested
- Reiki
- Keywords
- Reiki, functional status, pain, knee osteoarthritis
- Medical subject headings
- Osteoarthritis, Knee, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ReikiOther
Reiki is based on the belief that disease occurs when an energy center is blocked, and that the energy is transmitted through touch. In distant Reiki, Reiki practitioners followed the traditional Usui Reiki protocol for distant healing.
| Study group | Role | What they receive |
|---|---|---|
| Reiki Group | Patient Information Form (PIF), Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Holistic Well-Being Scale (HWS) were administered to the Reiki group. After the pretests of the patients were completed, the primary investigator with Reiki second degree applied Reiki therapy to the patients for 40 minutes. On the second and third days, she applied distant reiki. After 3 days and 10 days after the patients were included in the study, the post-tests were performed by calling the patients. Receives: Other: Reiki | |
| Control Group | Patient Information Form (PIF), Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Holistic Well-Being Scale (HWS) were administered to the control group. After 3 days and 10 days after the patients were included in the study, the post-tests were performed by calling the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Personal Information Form
The form created by the researchers included 11 questions covering the sociodemographic characteristics of the patients such as gender, age, marital status and the characteristics of the disease/treatment process.
Measured: Baseline
Visual Analog Scale
It is a reliable and easily applicable scale used to measure the severity of pain in patients, accepted in the world literature. The scale, which was used to digitize the values that could not be measured numerically, was used to evaluate the pain intensity of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. In addition, high scores indicate increased pain intensity.
Measured: Change from baseline Visual Analog Scale at 3 days and 10 days
Western Ontario and McMaster Universities Osteoarthritis Index
It is a valid and reliable index that is widely used for the evaluation of patients with osteoarthritis. The WOMAC Osteoarthritis index, which was validated and reliable in Turkish by Tüzün et al. in our country, consists of three sections and 24 questions in which pain, stiffness and physical function are questioned. Each question was scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The maximum scores that can be obtained from the index are 20 for the pain subgroup, 8 for stiffness, and 68 for physical function. High scores indicate increased pain and stiffness and impaired physical function.
Measured: Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index at 3 days and 10 days
Holistic Well-Being Scale
The scale is graded from disagree (1) to completely agree (10). The minimum score of the scale is 10 and the maximum score is 260, and as the score obtained from the scale increases, holistic well-being improves.
Measured: Change from baseline Holistic Well-Being Scale at 3 days and 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2022
- Study start24 Jun 2022
- Primary completion20 Jan 2023 (estimated)
- Study completion30 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
- Target duration
- 2 Weeks
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURSEMIN UNAL, Ankara Medipol University
- Investigators
- Nursemin Unal, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05665959
- Sponsor's protocol ID
- 129
- Status last verified
- Jan 2023
- First submitted
- 9 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 11642645Hawker 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.
PubMed 22588748Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
PubMed 15639634Notte 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.
PubMed 26760383Topdemir 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.
PubMed 33836405Bannuru 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.
PubMed 31278997
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reiki Therapy on Pain, Functional Status and Holistic Well-being in Patients With Knee Osteoarthritis: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05665959
- Acronym / sponsor ID
- 129
- Conditions
- Knee Osteoarthritis, Pain
- Keywords
- Reiki, functional status, pain, knee osteoarthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 24 Jun 2022 (actual)
- Primary completion
- 20 Jan 2023 (estimated)
- Study completion
- 30 Jan 2023 (estimated)
- First posted
- 27 Dec 2022 (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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 2 Weeks
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Reiki Group | – | Other: ReikiPatient Information Form (PIF), Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Holistic Well-Being Scale (HWS) were administered to the Reiki group. After the pretests of the patients were completed, the primary investigator with Reiki second degree applied Reiki therapy to the patients for 40 minutes. On the second and third days, she applied distant reiki. After 3 days and 10 days after the patients were included in the study, the post-tests were performed by calling the patients. |
| Control Group | – | –Patient Information Form (PIF), Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) and Holistic Well-Being Scale (HWS) were administered to the control group. After 3 days and 10 days after the patients were included in the study, the post-tests were performed by calling the patients. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients were included who has grade 2 or three knee osteoarthritis.
Key inclusion criteria (2 listed)
- Grade 2-3 osteoarthritis according to the Kellgren Lawrence scale,
- Patients aged 40 and over
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| ReikiReiki is based on the belief that disease occurs when an energy center is blocked, and that the energy is transmitted through touch. In distant Reiki, Reiki practitioners followed the traditional Usui Reiki protocol for distant healing. | Other | Reiki Group |
Primary outcome
Personal Information Form
Time frame: Baseline
The form created by the researchers included 11 questions covering the sociodemographic characteristics of the patients such as gender, age, marital status and the characteristics of the disease/treatment process.
Visual Analog Scale
Time frame: Change from baseline Visual Analog Scale at 3 days and 10 days
It is a reliable and easily applicable scale used to measure the severity of pain in patients, accepted in the world literature. The scale, which was used to digitize the values that could not be measured numerically, was used to evaluate the pain intensity of the patients. A minimum of 0 and a maximum of 10 points can be obtained from the scale. In addition, high scores indicate increased pain intensity.
Western Ontario and McMaster Universities Osteoarthritis Index
Time frame: Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index at 3 days and 10 days
It is a valid and reliable index that is widely used for the evaluation of patients with osteoarthritis. The WOMAC Osteoarthritis index, which was validated and reliable in Turkish by Tüzün et al. in our country, consists of three sections and 24 questions in which pain, stiffness and physical function are questioned. Each question was scored on a Likert scale as 0=absent, 1=mild, 2=moderate, 3=severe, 4=very severe. The maximum scores that can be obtained from the index are 20 for the pain subgroup, 8 for stiffness, and 68 for physical function. High scores indicate increased pain and stiffness and impaired physical function.
Holistic Well-Being Scale
Time frame: Change from baseline Holistic Well-Being Scale at 3 days and 10 days
The scale is graded from disagree (1) to completely agree (10). The minimum score of the scale is 10 and the maximum score is 260, and as the score obtained from the scale increases, holistic well-being improves.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Background: PubMed 11642645McConnell 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.
- Background: PubMed 22588748Hawker 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.
- Background: PubMed 15639634Tuzun EH, Eker L, Aytar A, Daskapan A, Bayramoglu M. Acceptability, reliability, validity and responsiveness of the Turkish version of WOMAC osteoarthritis index. Osteoarthritis Cartilage. 2005 Jan;13(1):28-33. doi: 10.1016/j.joca.2004.10.010.
- Background: PubMed 26760383Notte 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.
- Background: PubMed 33836405Topdemir 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.
- Background: PubMed 31278997Bannuru 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.
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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.
Nursemin Unal principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Pain, run by Ankara Medipol University at 1 site 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 2 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: status not confirmed, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nursemin Unal (+905077433629, nurse_unal@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Personal Information Form (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05665959, which also lists 6 linked publications.
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 20 Jan 2023.