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

Supportive Care Clinical Trial

Official title:

The Effect of Reiki on Surgical Fear and Anxiety

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06134453
• Other study ID #: HS312
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: June 2024
• Source: Cukurova University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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".

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 15, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Supportive Care

Intervention

Other:
• Reiki/Sham Reiki
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.

Locations

Country	Name	City	State
Turkey	Cukurova University	Adana

Sponsors (1)

Lead Sponsor	Collaborator
Cukurova University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of participants' surgical fear mean scores before and after Reiki application	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.	[Time Frame: day 0]
Primary	Comparison of participants' "Surgical Anxiety Scale" average scores before and after Reiki application	"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.	[Time Frame: day 0]