Clinical trial NCT06296680: Reiki for Cancer: Pain, Anxiety, and Stress
Official title: The Effect of Reiki Applied to Cancer Patients on Pain, Anxiety, and Stress Levels: A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Therapeutic Touch
Cancer
Keywords: Reiki
Cancer
Pain
Anxiety
Stress
Nursing
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2024-03-06
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: This study is a three-arm intervention trial. Reiki was applied to the intervention group, Sham Reiki to the placebo group, and Progressive Relaxation Exercise to the control group. The effects of these three methods applied to cancer patients on their levels of pain, anxiety, and cortisol were examined.
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to investigate the effects of Reiki, Sham Reiki, and Progressive Relaxation Exercise on the levels of pain, anxiety, and stress in cancer patients.

The main questions it aims to answer are:

* Question 1: The effect of Reiki applied to cancer patients on the level of pain within the time series is higher in favor of the intervention group.
* Question 2: The effect of Reiki applied to cancer patients on the level of anxiety within the time series is higher in favor of the intervention group.
* Question 3: The effect of Reiki applied to cancer patients on cortisol levels within the time series is higher in favor of the intervention group.
* Question 4: The effect of Reiki applied to cancer patients on the level of stress within the time series is higher in favor of the intervention group.
* Participants have answered the questions in the Individual Identification Form, Visual Comparison Scale, State Anxiety Scale and Perceived Stress Scale and serum cortisol levels were evaluated in the pretest.
* Afterwards, the patients in the intervention group received Reiki for four consecutive days, the patients in the placebo group received Sham Reiki, and the patients in the control group received Progressive Relaxation Exercise.
* The patients in the experimental group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four days, with an average of three minutes.
* The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four days, with an average of three minutes.
* Progressive Relaxation Exercise (PRE) group patients received PRE for four days.
* On the 4th day, pain and anxiety levels (0-10 Likert-type scale) of the patients were evaluated after the last applications.
* On the 21st day, the day of the next chemotherapy cycle, pain and anxiety levels were evaluated, state anxiety scale and perceived stress scale were administered, and serum cortisol level was evaluated in the morning before the start of chemotherapy.
* At the 3rd month follow-up, pain and anxiety levels (0-10 Likert-type scale), state anxiety scale and perceived stress scale were evaluated.

Detailed description: Patients were assigned to intervention, placebo, and control groups according to a randomization list. Laboratory fees for serum cortisol analyses were covered from a separate budget to ensure patients under the coverage of the Social Security Institution did not experience any deduction of fees. For each patient consenting to participate in the study, contact was made with the Ege University Faculty of Medicine Project and Special Services Coordination Center (PROKOM) for "Research Patient Identification", followed by contacting the Hospital Information Processing Department to open a "Research Patient" record. Laboratory requisitions for patients were made by the attending physician. Following serum cortisol analyses, data from the "Individual Identification Form, Visual Analog Scale, State Anxiety Inventory, Perceived Stress Scale" were collected from patients. Patients consenting to participate in the study were then initiated on treatment plans by a researcher with Level One certification in Reiki and PGE (Progressive Relaxation Exercise). Sham Reiki was administered by Sham Reiki practitioners. Patient rooms in the clinic were single occupancy, and efforts were made to control noise during interventions. Any accompanying family member/caregiver present in the room during the intervention was asked to leave for the duration of the application.

* Intervention Group (Reiki Group):
* Pre-test: Prior to initiating Reiki application, blood samples were obtained from the patients to assess serum cortisol levels; subsequently, data from the "Individual Identification Form, Visual Analog Scale, State Anxiety Inventory, Perceived Stress Scale" were collected by the researcher through face-to-face interviews. Reiki was administered for four days at designated times. Reiki was applied for a total duration of 25-30 minutes, with approximately three minutes per chakra region and the area of pain, while the patient was in a supine position, and the researcher's hands were positioned two to three centimeters above the chakra regions.
* Fourth-day follow-up: Data from the Visual Analog Scale were collected, and anxiety scores were evaluated.
* Twenty-first-day follow-up: Patients' serum cortisol levels were re-evaluated just before the start of their next chemotherapy session (between days 21-28), before initiating their current medical treatment (patients use cortisol alongside chemotherapy treatment), and data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected.
* Three-month follow-up: Data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected from the patients.
* Placebo Group (Sham Reiki Group):
* Pre-test: Prior to initiating Sham Reiki application, blood samples were obtained from the patients to assess cortisol levels; subsequently, data from the "Individual Identification Form, Visual Analog Scale, State Anxiety Inventory, Perceived Stress Scale" were collected by the researcher through face-to-face interviews. Sham Reiki was administered for four days at designated times. In this study, Sham Reiki practitioners mimicked a Reiki session by moving their hands over the patient's body in a specific sequence for a duration of 25-30 minutes. Sham Reiki was applied for a total duration of 25-30 minutes, with approximately three minutes per chakra region and the area of pain, while the patient was in a supine position, and the practitioner's hands were positioned two to three centimeters above the chakra regions. Sham Reiki practitioners consisted of nurses who did not believe in the transfer of biological field energy.
* Fourth-day follow-up: Data from the Visual Analog Scale were collected, and anxiety scores were evaluated.
* Twenty-first-day follow-up: Patients' serum cortisol levels were re-evaluated just before the start of their next chemotherapy session (between days 21-28), before initiating their current medical treatment, and data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected.
* Three-month follow-up: Data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected from the patients.
* Control Group (PGE Group):
* Pre-test: Prior to initiating PGE application, blood samples were obtained from the patients to assess cortisol levels; subsequently, data from the "Individual Identification Form, Visual Analog Scale, State Anxiety Inventory, Perceived Stress Scale" were collected by the researcher through face-to-face interviews. Patients received PGE for four days.
* Fourth-day follow-up: Data from the Visual Analog Scale were collected again, and anxiety scores were evaluated.
* Twenty-first-day follow-up: Patients' serum cortisol levels were re-evaluated just before the start of their next chemotherapy session (between days 21-28), before initiating their current medical treatment, and data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected again.
* Three-month follow-up: Data from the Visual Analog Scale, State Anxiety Inventory, and Perceived Stress Scale were collected from the patients.

Eligibility criteria: Inclusion Criteria:

* Conscious
* Aged 18 and over
* Without serious mental disorders (Bipolar Disorder, Schizophrenia, Schizoaffective Disorder, Major Depression, Personality Disorders)
* Without visual and hearing impairments
* Capable of verbal communication
* Never received Reiki before
* Patients scoring 36 or above on the Perceived Stress Scale were included in the study.

Exclusion Criteria:

Patients using cortisol were not included in the study.

Primary outcomes:
measure: Stress levels
timeFrame: In the pre-test and on the 21st-day follow-up
Secondary outcomes:
measure: Anxiety levels
timeFrame: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
measure: Pain levels
timeFrame: In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Other outcomes:
Locations:
city: İzmir
country: Turkey
facility: Ege University
Study officials:
References: