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Completed

NCT Number: NCT06134453

Evaluation of the Effect of Reiki on Surgical Fear and Anxiety in Laparoscopic Cholecystectomy; Randomized Controlled Study

surgical intervention; It is defined as an emergency or planned treatment method for the purpose of diagnosis, treatment and symptom reduction in cases of deformity, injury, and disease with hands and tools. Although these interventions are practices aimed at protecting life, whether it is large or small, urgent or planned, it is both physiological and psychological trauma for the patient. The decision of surgical intervention may cause anxiety in individuals regardless of the type of surgical procedure. Fear of anesthesia, fear of death, possibility of postoperative complications, pain, changes in activities of daily living, loss of social life and loss of control may cause anxiety. Reiki, a complementary and alternative medicine (CAM) method, is a bioenergy based on the body's energy use and has been used for centuries in the prevention and treatment of certain diseases in various cultures. Reiki is thought to help balance the body's natural energy systems and reduce anxiety by transferring existing energy through the hands. Studies on the effectiveness of reiki, which is increasingly used worldwide and recommended as a treatment approach in health care, are insufficient. The aim of this study, which was planned as a three-group interventional randomized control, was to evaluate the effect of reiki on surgical fear and anxiety of patients who will undergo laparoscopic cholecystectomy.

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Key information

Conditions

Supportive Care

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cukurova University

Adana, 01130, Turkey (Türkiye)

About this study

The results of the power analysis using the Gpower 3.1.9.2 program, it was planned to have 16 patients in reiki, 16 patients in sham reiki, and 16 patients in the control group, and study groups were determined by simple randomization method. The research data were collected between November 2022 and September 2023 in the operating room waiting room, in a quiet single room. Pre-application, "Personal Information Form", "Surgical Fear Form" and Surgical Anxiety Form" was applied to 12 patients who met the study criteria with the permission of the ethics committee. Data were collected in the operating room waiting room before and after Reiki. After obtaining the patient's consent, the Personal Information Form, the Surgical Fear Scale, and the Surgical Anxiety Scale were applied and recorded. According to randomization, the patients in the reiki/sham reiki group were taken to a quiet single room, and reiki/sham reiki was applied for approximately 25-30 minutes. Reiki application was applied by a researcher who received Reiki Master level training, and sham Reiki was applied by a health professional who did not receive Reiki training. A written protocol is provided to both the Reiki practitioner and Sham Reiki practitioner describing hand positions, areas of practice, sequence, and times. The "Surgical Fear Scale" and "Surgical Anxiety Scale" were applied again 5 minutes after the end of the application. In the control group according to randomization. The "Personal Information Form" was recorded by applying the "Surgical Fear Scale" and the "Surgical Anxiety Scale". 30 minutes of the evaluation were recorded by repeating the "Surgical Fear Scale" and "Surgical Anxiety Scale".

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 age range,
  • No vision-hearing problem,
  • Able to communicate verbally
  • No diagnosed psychiatric problem,
  • No history or current history of substance use,
  • will receive general anesthesia,
  • ASA I, II
  • Laparoscopic cholecystectomy was planned,

Exclusion criteria

  • Patients who develop a serious complication after surgery (patients who may need respiratory support and close monitoring due to metabolic disorders, hypothermia, or hemodynamic instability)
  • Patients who have previously received energy therapies such as Reiki Touch Therapy / Therapeutic Touch / Healing Touch

Treatment and study plan

Reiki/Sham Reiki

Other

Reiki will be applied to the patients by the research nurse who is at the Reiki master level. Sham Reiki will remain in the same position and for the same duration as if Reiki was performed by a healthcare professional who has not received Reiki training, but Reiki energy will not be given to the patient. No intervention will be made to the control group.

Other names: Control Group

Primary outcomes

  1. Comparison of participants' surgical fear mean scores before and after Reiki application

    Time frame: [Time Frame: day 0]

    In the "Surgical Fear Scale", the lowest score that can be obtained from the subscales is 0 and the highest score is 40. The lowest score of the scale is 0 and the highest is 80. A high score indicates that fear is high.

  2. Comparison of participants' "Surgical Anxiety Scale" average scores before and after Reiki application

    Time frame: [Time Frame: day 0]

    "The highest score that can be obtained from the Surgical Anxiety Scale is 80, and the lowest score is 20. The higher the total anxiety score, the higher the person's anxiety level is interpreted.

Sponsors and collaborators

Lead sponsor

Cukurova University

Other

Registry information

Official study title

The Effect of Reiki on Surgical Fear and Anxiety

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 18, 2023
Registry last updated
Feb 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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