NCT06134453

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

March 15, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2024

Completed
Last Updated

February 12, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

August 6, 2023

Last Update Submit

February 11, 2025

Conditions

Keywords

CholecystectomySurgical FearSurgical AnxietyReiki

Outcome Measures

Primary Outcomes (2)

  • 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]

  • 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]

Study Arms (3)

Reiki

EXPERIMENTAL

According to randomization, patients in the reiki group will be taken to a quiet single room and reiki will be applied for approximately 25-30 minutes. Reiki practice will be applied by a researcher who has been trained at the Reiki Master level.

Other: Reiki/Sham Reiki

Sham Reiki

SHAM COMPARATOR

According to randomization, the patients in the sham reiki group were taken to a quiet single room and sham reiki was applied for approximately 25-30 minutes. will be applied. According to random distribution, patients in the sham reiki group will be taken to a quiet single room and sham reiki will be applied for approximately 25-30 minutes. Sham Reiki will be administered by a healthcare professional who has not received Reiki training. Their hands will remain in the same position and for the same duration as if they were actually doing Reiki, but Reiki energy will not be given to the patient.

Other: Reiki/Sham Reiki

Control Group

NO INTERVENTION

The control group will be given routine care in the pre-operative waiting room without any intervention, and the data collection tools will be applied at the same time as the experimental group, twice at 30-minute intervals.

Interventions

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.

Also known as: Control Group
ReikiSham Reiki

Eligibility Criteria

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

You may qualify if:

  • 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,

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cukurova University

Adana, 01130, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sham reiki will be applied by a nurse who has not received reiki training. He will hold his hands in accordance with the Reiki protocol in the specified chakra areas of the patient for the specified time.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Reiki, Sham Reiki, Control Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 6, 2023

First Posted

November 18, 2023

Study Start

March 15, 2024

Primary Completion

May 30, 2024

Study Completion

October 15, 2024

Last Updated

February 12, 2025

Record last verified: 2025-02

Locations