Reiki for Cancer: Pain, Anxiety, and Stress

Cancer Clinical Trial

Official title:

The Effect of Reiki Applied to Cancer Patients on Pain, Anxiety, and Stress Levels: A Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06296680
• Other study ID #: EGE_UNI_SEVCAN_OZ_KAHVECI_0001
• Status: Completed
• Phase: N/A
• Start date: September 2, 2022
• Est. completion date: June 30, 2023

Study information

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

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: June 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cancer
• Therapeutic Touch

Intervention

Other:
• Reiki
The patients in the intervention group received Reiki to the seven chakra regions and additional areas with pain for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.
• Sham Reiki
The patients in the placebo group received Sham Reiki to the seven chakra regions for a total duration of 25-30 minutes for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.
• Progressive Relaxation Exercise
PRE group patients received PRE for four consecutive days. On the 4th day, pain and anxiety levels of the patients were evaluated after the last applications. On the 21st day, 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, state anxiety scale and perceived stress scale were evaluated.

Locations

Country	Name	City	State
Turkey	Ege University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Ege University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stress levels	Stress levels of the patients was measured by Perceived Stress Scale and serum cortisol levels. The 14-item five-point Likert-type scale consists of two factors. The lowest score a participant can obtain from this scale is 0 and the highest score is 56. A high score indicates that the person's perception of stress is high. A high total score means that the perceived stress level is high. As a result of the score between 0-35, it can be said that the participants are in a positive stress level, they can cope with stress effectively and the coping mechanisms they use are functional. It can be said that the methods used by the participants with a score range between 36-56 are not functional, that is, they cannot cope with stress effectively. Prior to initiating the interventions, blood samples were obtained from the patients to assess serum cortisol levels; on the twenty-first day follow-up, they were reassessed before the commencement of medical treatment.	In the pre-test and on the 21st-day follow-up
Secondary	Anxiety levels	Anxiety level of the patients was evaluated with 0-10 Likert-type scale and State Anxiety Inventory (STAI-S). Anxiety level of the patients was evaluated with 0-10 Likert-type scale and State Anxiety Inventory (STAI-S). The original form was designed by Spielberger et al. (1970) to determine the state and trait anxiety levels of individuals separately. The scale can be administered to individuals aged 14 years and older. There are 20 items in the scale and the scale provides information about the anxiety level of the patient. There are ten inverted statements in the scale	In the pre-test, on the 4th-day, on the 21st-day and 3rd month
Secondary	Pain levels	The pain level of the patients was evaluated with a 0-10 Likert-type scale called Visual Analogue Scale (VAS). The VAS is a scale used to determine the level of pain between "0: no pain" and "10: unbearable pain". VAS is considered a reliable and valid measurement tool in repeated measurements. It is used to assess the severity of acute pain. It has been noted to have higher sensitivity compared to other methods in evaluating pain severity.	In the pre-test, on the 4th-day, on the 21st-day and 3rd month