- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07442435
REIKI IN TOTAL KNEE ARTHROPLASTY PATIENTS (REIKI TKA ) (REIKI TKA)
THE EFFECT OF REIKI PRACTICE ON POSTOPERATIVE PAIN, MOBILIZATION, AND VITAL SIGNS IN PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL
Total knee arthroplasty (TKA) is commonly performed to improve mobility and quality of life in patients with degenerative joint diseases. However, severe postoperative pain, limited mobilization, and fluctuations in vital signs negatively affect recovery, particularly within the first 72 hours after surgery.
Reiki is a non-invasive complementary therapy aimed at enhancing the body's self-healing capacity through energy transfer. This randomized controlled trial aims to evaluate the effects of Reiki on postoperative pain, mobilization, and vital signs in patients undergoing total knee arthroplasty.
Participants will be randomly assigned to either a Reiki intervention group or a control group receiving routine postoperative care. Outcomes will be assessed using validated pain and mobility scales and objective vital sign measurements at the 24th, 48th, and 72nd postoperative hours.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Total knee arthroplasty (TKA) is a widely performed surgical procedure for the management of advanced osteoarthritis and other degenerative joint diseases. Although TKA aims to improve functional mobility and quality of life, patients frequently experience severe postoperative pain, restricted movement, and physiological stress responses, particularly within the first 72 hours following surgery. Inadequate pain control during this early postoperative period may delay mobilization, prolong hospital stay, increase opioid consumption, and negatively affect overall recovery outcomes.
Complementary and integrative therapies have increasingly been incorporated into nursing care to support postoperative recovery. Reiki is a non-invasive, energy-based complementary therapy developed by Dr. Mikao Usui in Japan. It is based on the concept of facilitating the body's self-healing capacity through gentle touch or hands positioned slightly above the body to promote relaxation and physiological balance. Previous studies suggest that Reiki may reduce pain intensity, alleviate anxiety, and contribute to stabilization of physiological parameters; however, evidence remains limited and inconsistent, particularly in orthopedic surgical populations. Moreover, no randomized controlled study has comprehensively evaluated the simultaneous effects of Reiki on postoperative pain, mobilization, and vital signs in patients undergoing total knee arthroplasty.
This study is designed as a randomized, single-blind (statistician-blinded), pretest-posttest controlled clinical trial. The study will be conducted in the Orthopedics Department of Sinop Atatürk State Hospital between September 2025 and September 2026. A total of 90 patients undergoing elective total knee arthroplasty will be enrolled. Sample size was determined through power analysis (80% power, 5% significance level, effect size = 0.60). Participants will be randomly assigned to either the Reiki intervention group (n=45) or the control group (n=45) using block randomization to ensure balanced group allocation.
Participants in the intervention group will receive standardized Reiki therapy administered by a certified Reiki practitioner who has completed Level I and Level II Reiki training. Reiki will be applied at the 24th, 48th, and 72nd postoperative hours, at least four hours after administration of routine analgesic medication. Each session will last approximately 30-45 minutes. The application will involve gentle touch or hands positioned approximately 2 cm above the body at seven primary energy centers (crown, forehead, throat, heart, solar plexus, sacral, and root regions) as well as knee and foot areas. Each point will receive approximately 3-5 minutes of focused application.
The control group will receive routine postoperative care according to institutional protocols without Reiki intervention.
Outcome measures will be assessed immediately before each intervention (pretest) and five minutes after completion (posttest) at the 24th, 48th, and 72nd postoperative hours.
The primary outcome is postoperative pain intensity measured using the Visual Analog Scale (VAS). Secondary outcomes include patient mobilization level measured by the Patient Mobility Scale, vital signs (systolic and diastolic blood pressure, heart rate, and oxygen saturation), number of analgesic doses required after intervention, and time to analgesic requirement.
Data will be analyzed using SPSS statistical software. Descriptive statistics, chi-square tests, one-way ANOVA, paired t-tests, and independent samples t-tests will be used as appropriate. Statistical significance will be set at p < 0.05 with a 95% confidence interval.
Ethical approval has been obtained from the Clinical Research Ethics Committee of Ondokuz Mayıs University. Written informed consent will be obtained from all participants prior to enrollment. Patient confidentiality and data protection principles will be strictly maintained.
This study aims to provide high-level evidence regarding the effectiveness of Reiki as a complementary nursing intervention in postoperative care for total knee arthroplasty patients. Findings may contribute to improving pain management strategies, enhancing early mobilization, reducing reliance on opioid analgesics, and promoting patient-centered integrative care approaches in orthopedic surgery settings.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: FETIH BISGIN
- Phone Number: +90-0544-684-6334
- Email: fetihbisgin@gmail.com
Study Contact Backup
- Name: SENAY ARLI
- Phone Number: +90-0541-813-9628
- Email: senay1981@yahoo.com
Study Locations
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Sinop, Turkey (Türkiye), 57000
- Recruiting
- Sinop Ataturk State Hospital
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Contact:
- SEMRA TIRYAKI
- Phone Number: +90-0506-355-0719
- Email: semratiryaki0519@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults aged 18 years and older
- Undergoing elective (planned) primary total knee arthroplasty
- Not receiving general anesthesia
- Able to communicate effectively and understand the study protocol
- Hospitalized for two days following total knee arthroplasty
Exclusion Criteria:
- Refusal to participate in the study
- Previous total knee arthroplasty or revision knee surgery
- Prior experience with Reiki, Therapeutic Touch, Healing Touch, or other energy-based therapies
- Development of serious postoperative complications (e.g., bleeding, infection)
- Diagnosis of chronic pain syndrome (e.g., fibromyalgia, chronic low back pain)
- Neuropsychiatric disorders such as dementia, Alzheimer's disease, schizophrenia, or major depressive disorder
- Current use of psychotropic medications
- Regular use of opioids or corticosteroids
- Use of patient-controlled analgesia (PCA)
- Major surgery or severe trauma within the past 6 months
- Admission to the intensive care unit postoperatively
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Reiki Therapy Group
Participants in this group will receive standardized Reiki therapy sessions in addition to routine postoperative care during the first 48 hours after total knee arthroplasty.
Reiki will be administered once daily, and outcome measures will be assessed before and after each session.
|
The researcher will administer Reiki touch therapy to the Reiki treatment group three times in total, each session lasting 30-45 minutes, with the sessions occurring at least four hours after taking pain medication during the first 24 and 48 hours post-surgery.
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No Intervention: Control Group (Routine Care)
Participants in this group will receive routine postoperative care only during the first 48 hours after total knee arthroplasty without any Reiki intervention.
Outcome measures will be assessed at the same time points as the intervention group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Postoperative Pain Intensity
Time Frame: Before the first Reiki session and after Reiki sessions at 24 and 48 hours postoperatively.
|
Postoperative pain intensity will be measured using the Visual Analog Scale for Pain (VAS), a 10-centimeter scale ranging from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst imaginable pain."
Higher scores represent greater pain intensity and therefore a worse outcome.
|
Before the first Reiki session and after Reiki sessions at 24 and 48 hours postoperatively.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain and Difficulty During Mobilization (Patient Mobility Scale Total Score)
Time Frame: 24 and 48 hours postoperatively
|
Pain and difficulty during mobilization will be assessed using the Patient Mobility Scale.
The scale evaluates four postoperative activities (turning in bed, sitting, standing, and walking).
For each activity, pain and difficulty are measured separately using 15-centimeter Visual Analog Scales (VAS).
Scores for pain and difficulty are combined for each activity, and activity scores are summed to obtain a total score ranging from 0 to 120.
Higher total scores indicate greater pain and difficulty during mobilization and therefore represent a worse outcome.
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24 and 48 hours postoperatively
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Heart Rate
Time Frame: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Heart rate will be measured in beats per minute (bpm) using a standard bedside cardiac monitor.
Higher values indicate increased sympathetic activity.
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Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
|
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Systolic Blood Pressure
Time Frame: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.
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Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Diastolic Blood Pressure
Time Frame: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.
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Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Oxygen Saturation
Time Frame: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Peripheral oxygen saturation (SpO₂) will be measured as a percentage using pulse oximetry.
Higher values indicate better oxygenation.
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Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ayoğlu T. The effect of preoperative education on patients' self-efficacy perception and recovery process. [master's thesis]. [Istanbul]. Istanbul University; 2011. Anderson, K., et al. (2023). Complementary Therapies in Postoperative Care: A Focus on Reiki. Journal of Advanced Nursing, 79(2), 456-465. Arslan, S., & Özkan, H. (2020). The Effect of Reiki on Postoperative Pain and Anxiety: A Nursing Study. Journal of Nursing Research Development, 22(1), 45-52. Baldwin, A. L., Yaşame, A., Brownell, E., Kryak, E., Rand, W. (2017). Effects of Reiki on Pain, Anxiety, and Blood Pressure in Patients Undergoing Knee Replacement: A Pilot Study. Holistic Nursing Practice 31(2):p 80-89, March/April. | DOI: 10.1097/HNP.0000000000000195. Başer Akın, E. (2022). Investigation of the Effect of Reiki Application on Pain, Fatigue, and Itching in Hemodialysis Patients (Doctoral Thesis). Sivas Cumhuriyet University Institute of Health Sciences, Department of Internal Medicine Nursing, Sivas. Brown, A., et al. (2021). Early Mobilization After Total Knee Replacement: A Systematic Review. Journal of Rehabilitation Medicine, 53(4), 1-10. Campbell, D. T., & Stanley, J. C. (1963). Experimental and quasi-experimental designs for research. Houghton Mifflin. Clark, M., et al. (2023). Reiki and Its Application in Modern Nursing Practice. Holistic Nursing Care, 12(1), 15-22. Cohen, J. (1988). Statistical power analysis for the behavioral sciences (2nd ed.). Routledge. Demir Doğan, M. (2018). The effect of reiki on pain: A meta-analysis, Complementary Demir, A., & Aydın, S. (2022). The Effect of Reiki Application on Patient Satisfaction and Length of Stay in the Hospital. Journal of Health Sciences and Nursing, 10(2), 78-85. Doğan, H.D., Derya İster, E. (2023) "An Examination of Nursing Theses Using Reiki in Turkey." Istanbul Rumeli University Journal of Health Sciences, 2 (1): 59-74. Eti-Aslan F. (2002). Pain assessment methods. Cumhuriyet University School of Nursing Journal, 6(1):9-16. Faul
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- B.30.2.ODM.0.20.08/505
- 6570 (Other Grant/Funding Number: Ondokuz Mayıs University Scientific Research Projects Coordination Unit)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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