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临床试验/NCT07442435
NCT07442435招募中不适用

THE EFFECT OF REIKI PRACTICE ON POSTOPERATIVE PAIN, MOBILIZATION, AND VITAL SIGNS IN PATIENTS UNDERGOING TOTAL KNEE ARTHROPLASTY: A RANDOMIZED CONTROLLED TRIAL

Ondokuz Mayıs University1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2026年2月9日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
90
试验地点
1
主要终点
Postoperative Pain Intensity

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

研究组 & 干预措施

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.

干预措施: Reiki Therapy (Other)

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.

结局指标

主要结局

Postoperative Pain Intensity

时间窗: 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.

次要结局

  • 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.)

研究者

发起方
Ondokuz Mayıs University
申办方类型
Other
责任方
Principal Investigator
主要研究者

SENAY KARADAG ARLI

Professor, Department of Nursing

Ondokuz Mayıs University

研究点 (1)

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