Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-04-05 @ 12:47 PM
Study NCT ID:
NCT07442435
Status:
RECRUITING
Last Update Posted:
2026-03-02
First Post:
2026-02-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REIKI IN TOTAL KNEE ARTHROPLASTY PATIENTS (REIKI TKA )
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019124', 'term': 'Therapeutic Touch'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '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.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-02-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-24', 'studyFirstSubmitDate': '2026-02-18', 'studyFirstSubmitQcDate': '2026-02-24', 'lastUpdatePostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Intensity', 'timeFrame': 'Before the first Reiki session and after Reiki sessions at 24 and 48 hours postoperatively.', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain and Difficulty During Mobilization (Patient Mobility Scale Total Score)', 'timeFrame': '24 and 48 hours postoperatively', 'description': '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.'}, {'measure': 'Heart Rate', 'timeFrame': 'Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.', 'description': 'Heart rate will be measured in beats per minute (bpm) using a standard bedside cardiac monitor. Higher values indicate increased sympathetic activity.'}, {'measure': 'Systolic Blood Pressure', 'timeFrame': 'Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.', 'description': 'Systolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.'}, {'measure': 'Diastolic Blood Pressure', 'timeFrame': 'Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.', 'description': 'Diastolic blood pressure will be measured in millimeters of mercury (mmHg) using a standard non-invasive blood pressure monitor.'}, {'measure': 'Oxygen Saturation', 'timeFrame': 'Baseline (before the first Reiki session), and 15 minutes after Reiki sessions at 24 and 48 hours postoperatively.', 'description': 'Peripheral oxygen saturation (SpO₂) will be measured as a percentage using pulse oximetry. Higher values indicate better oxygenation.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Reiki, Total Knee Arthroplasty, Postoperative Pain, Mobilization, Vital Signs, Nursing, Nursing Care'], 'conditions': ['Total Knee Arthroplasty (Postoperative Pain)']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}]}, 'descriptionModule': {'briefSummary': "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.\n\nReiki 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.\n\nParticipants 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.", 'detailedDescription': "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.\n\nComplementary 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.\n\nThis 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.\n\nParticipants 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.\n\nThe control group will receive routine postoperative care according to institutional protocols without Reiki intervention.\n\nOutcome measures will be assessed immediately before each intervention (pretest) and five minutes after completion (posttest) at the 24th, 48th, and 72nd postoperative hours.\n\nThe 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.\n\nData 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.\n\nEthical 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults aged 18 years and older\n* Undergoing elective (planned) primary total knee arthroplasty\n* Not receiving general anesthesia\n* Able to communicate effectively and understand the study protocol\n* Hospitalized for two days following total knee arthroplasty\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Previous total knee arthroplasty or revision knee surgery\n* Prior experience with Reiki, Therapeutic Touch, Healing Touch, or other energy-based therapies\n* Development of serious postoperative complications (e.g., bleeding, infection)\n* Diagnosis of chronic pain syndrome (e.g., fibromyalgia, chronic low back pain)\n* Neuropsychiatric disorders such as dementia, Alzheimer's disease, schizophrenia, or major depressive disorder\n* Current use of psychotropic medications\n* Regular use of opioids or corticosteroids\n* Use of patient-controlled analgesia (PCA)\n* Major surgery or severe trauma within the past 6 months\n* Admission to the intensive care unit postoperatively"}, 'identificationModule': {'nctId': 'NCT07442435', 'acronym': 'REIKI TKA', 'briefTitle': 'REIKI IN TOTAL KNEE ARTHROPLASTY PATIENTS (REIKI TKA )', 'organization': {'class': 'OTHER', 'fullName': 'Ondokuz Mayıs University'}, 'officialTitle': 'THE EFFECT OF REIKI PRACTICE ON POSTOPERATIVE PAIN, MOBILIZATION, AND VITAL SIGNS IN PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL', 'orgStudyIdInfo': {'id': 'B.30.2.ODM.0.20.08/505'}, 'secondaryIdInfos': [{'id': '6570', 'type': 'OTHER_GRANT', 'domain': 'Ondokuz Mayıs University Scientific Research Projects Coordination Unit'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Reiki Therapy Group', 'description': '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.', 'interventionNames': ['Other: Reiki Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group (Routine Care)', 'description': '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': [{'name': 'Reiki Therapy', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Reiki Therapy Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57000', 'city': 'Sinop', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'SEMRA TIRYAKI', 'role': 'CONTACT', 'email': 'semratiryaki0519@gmail.com', 'phone': '+90-0506-355-0719'}], 'facility': 'Sinop Ataturk State Hospital', 'geoPoint': {'lat': 42.02683, 'lon': 35.16253}}], 'centralContacts': [{'name': 'FETIH BISGIN', 'role': 'CONTACT', 'email': 'fetihbisgin@gmail.com', 'phone': '+90-0544-684-6334'}, {'name': 'SENAY ARLI', 'role': 'CONTACT', 'email': 'senay1981@yahoo.com', 'phone': '+90-0541-813-9628'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ondokuz Mayıs University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Nursing', 'investigatorFullName': 'SENAY KARADAG ARLI', 'investigatorAffiliation': 'Ondokuz Mayıs University'}}}}