Reiki Effects on Pain, Functional Status and Holistic Well-Being in Patients With Knee Osteoarthritis

January 19, 2023 updated by: NURSEMIN UNAL, Ankara Medipol University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
    • None Selected
      • Ankara, None Selected, Turkey, 06050

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients were included who has grade 2 or three knee osteoarthritis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: Reiki
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.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
Change from baseline Visual Analog Scale at 3 days and 10 days
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.
Change from baseline Western Ontario and McMaster Universities Osteoarthritis Index at 3 days and 10 days
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.
Change from baseline Holistic Well-Being Scale at 3 days and 10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ankara Medipol University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nursemin Unal, Ankara Medipol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2022

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 20, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 9, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 27, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 129

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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