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Total Knee Arthroplasty (Postoperative Pain)REIKI TKANCT07442435

REIKI IN TOTAL KNEE ARTHROPLASTY PATIENTS (REIKI TKA )

A study testing Reiki Therapy in people with Total Knee Arthroplasty (Postoperative Pain), run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Reiki Therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteTurkey (Türkiye)
Study dates
9 Feb 2026to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Turkey (Türkiye)1 site, 1 recruiting
  • Sinop Ataturk State Hospital

    Sinop, 57000

    SEMRA TIRYAKI, +90-0506-355-0719, semratiryaki0519@gmail.com

    Recruiting

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
Reiki Therapy
Keywords
Reiki, Total Knee Arthroplasty, Postoperative Pain, Mobilization, Vital Signs, Nursing, Nursing Care
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Reiki TherapyOther

    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.

Study groups in NCT07442435
Study groupRoleWhat they receive
Reiki Therapy GroupExperimentalParticipants 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.
Receives: Other: Reiki Therapy
Control Group (Routine Care)No interventionParticipants 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain Intensity

    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.

    Measured: Before the first Reiki session and after Reiki sessions at 24 and 48 hours postoperatively.

Secondary outcomes (5)
  1. Pain and Difficulty During Mobilization (Patient Mobility Scale Total Score)

    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.

    Measured: 24 and 48 hours postoperatively

  2. Heart Rate

    Heart rate will be measured in beats per minute (bpm) using a standard bedside cardiac monitor. Higher values indicate increased sympathetic activity.

    Measured: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.

  3. Systolic Blood Pressure

    Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.

    Measured: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.

  4. Diastolic Blood Pressure

    Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.

    Measured: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.

  5. Oxygen Saturation

    Peripheral oxygen saturation (SpO₂) will be measured as a percentage using pulse oximetry. Higher values indicate better oxygenation.

    Measured: Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Mar 2026
  2. Study start9 Feb 2026
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Reiki, Total Knee Arthroplasty, Postoperative Pain, Mobilization, Vital Signs, Nursing, Nursing Care This study is designed as a randomized, parallel-group, single-blind (statistician-blinded), pretest-posttest controlled clinical trial. Eligible participants undergoing elective total knee arthroplasty will be allocated in a 1:1 ratio to either the Reiki intervention group or the control group using block randomization to ensure balanced group assignment. The intervention group will receive standardized Reiki therapy in addition to routine postoperative care, while the control group will receive routine postoperative care alone. Outcome measures will be assessed at the 24th and 48th postoperative hours immediately before and five minutes after each session.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07442435
Sponsor's protocol ID
B.30.2.ODM.0.20.08/505
Other IDs
6570
Acronym
REIKI TKA
Status last verified
Feb 2026
First submitted
18 Feb 2026
Last updated
2 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data (IPD) collected in this study will not be shared. The dataset contains sensitive clinical information and was collected under institutional ethical approval that does not include provisions for public data sharing.

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

Questions about this trial

What is this clinical trial studying?

A study testing Reiki Therapy in people with Total Knee Arthroplasty (Postoperative Pain), run by Ondokuz Mayıs 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 5 inclusion and 11 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: looking for participants now, as of the sponsor's last update on 2 Mar 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact FETIH BISGIN (+90-0544-684-6334, fetihbisgin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain Intensity (time frame: Before the first Reiki session and after Reiki sessions at 24 and 48 hours postoperatively.). 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 NCT07442435, which also lists 1 linked publication.

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 2 Mar 2026.

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