NCT07442435

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
4mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress43%
Feb 2026Sep 2026

Study Start

First participant enrolled

February 9, 2026

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 2, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

March 2, 2026

Status Verified

February 1, 2026

Enrollment Period

7 months

First QC Date

February 18, 2026

Last Update Submit

February 24, 2026

Conditions

Keywords

Reiki, Total Knee Arthroplasty, Postoperative Pain, Mobilization, Vital Signs, Nursing, Nursing Care

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (5)

  • Pain and Difficulty During Mobilization (Patient Mobility Scale Total Score)

    24 and 48 hours postoperatively

  • Heart Rate

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

  • Systolic Blood Pressure

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

  • Diastolic Blood Pressure

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

  • Oxygen Saturation

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

Study Arms (2)

Reiki Therapy Group

EXPERIMENTAL

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.

Other: Reiki Therapy

Control Group (Routine Care)

NO INTERVENTION

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.

Interventions

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.

Reiki Therapy Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sinop Ataturk State Hospital

Sinop, 57000, Turkey (Türkiye)

RECRUITING

Related Publications (1)

  • 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

    BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study is single-blinded. The statistician (outcome assessor) responsible for data analysis will be blinded to group allocation. Participants and care providers will not be blinded due to the nature of the intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Department of Nursing

Study Record Dates

First Submitted

February 18, 2026

First Posted

March 2, 2026

Study Start

February 9, 2026

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Last Updated

March 2, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

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.

Locations