Reiki for Cancer: Pain, Anxiety, and Stress

NCT06296680 | Completed

• 1 other identifier: EGE_UNI_SEVCAN_OZ_KAHVECI_0001
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Therapeutic Touch; Cancer

Keywords

Reiki; Cancer; Pain; Anxiety; Stress; Nursing

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Anxiety levels

  In the pre-test, on the 4th-day, on the 21st-day and 3rd month

• Pain levels

  In the pre-test, on the 4th-day, on the 21st-day and 3rd month

Study Arms (3)

Reiki

EXPERIMENTAL

In the intervention group, patients received an energy therapy called Reiki. Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, the researcher's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention.

Other: Reiki

Sham Reiki

SHAM COMPARATOR

In the placebo group, patients received Sham Reiki. Sham Reiki was administered to cancer patients for four consecutive days at specified times. During this procedure, while the patient was in the supine position, Sham Reiki practitioner's hands were placed approximately two to three centimeters above the chakra regions of the patient, covering the seven chakra areas as well as the areas experiencing pain. The application lasted a total of 25-30 minutes. Silence was maintained in the patient's room during the intervention.

Other: Sham Reiki

Progressive Relaxation Exercise

ACTIVE COMPARATOR

Silence was maintained in the patient's room during the intervention. At the beginning of the session, the patient is asked to assume the most comfortable seated or supine position. Then, they are instructed to close their eyes, take deep breaths, direct their thoughts to their own body and the muscle groups being treated, notice the tension and relaxation in the muscle groups during the exercise, and continue to breathe regularly. This practice was conducted in four parts of the body: hands and arms; face and shoulders; chest, abdomen, hips; legs and feet.

Other: Progressive Relaxation Exercise

Interventions

Reiki OTHER

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.

Reiki

Sham Reiki OTHER

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.

Sham Reiki

Progressive Relaxation Exercise OTHER

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.

Also known as: the patients in the control group received Progressive Relaxation Exercise.

Progressive Relaxation Exercise

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients using cortisol were not included in the study.

Sponsors & Collaborators

• Ege University: lead

Study Sites (1)

Ege University

Izmir, 35100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neoplasms; Pain; Anxiety Disorders

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: In order to prevent assessment bias, blinding was implemented throughout the collection of data from patients, evaluation of the effectiveness and reliability of the applied dependent variables, data processing, reporting, and statistical analysis. The researcher was provided with a randomization list by a statistical expert. The researcher was included in the study without knowing which group the patients would be assigned to, and the patients were also enrolled without knowledge of their group assignment. Therefore, this study was conducted as a three-arm, double-blind, randomized follow-up study in the experimental research model, with intervention, placebo, and control groups.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Model Details: 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.

Study Record Dates

• First Submitted: February 29, 2024
• First Posted: March 6, 2024
• Study Start: September 2, 2022
• Primary Completion: November 30, 2022
• Study Completion: June 30, 2023
• Last Updated: March 6, 2024

Record last verified: 2024-02

Locations

TU (1)