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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.

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.

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.

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

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

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.

Progressive Relaxation Exercise

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.

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.

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.

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.

Reiki for Cancer: Pain, Anxiety, and Stress

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

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.

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

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.

Ege University

Research Assistant

Syndrome

Burnout, Psychological

Caregiver Burden

Stress, Psychological

Behavioral Symptoms

Reiki was applied to this arm by the researcher who completed her second level education according to the Usui method, for 45 minutes once a week for 6 weeks and by touching the 9 main points in line. A saliva sample was taken from the participants in order to determine the stress level through cortisol and Caregiver Stress Scale (CSS) was applied in the first week of Reiki application. Systolic and diastolic blood pressures and pulse rates were measured for six weeks before and after each application. At the end of six weeks, saliva samples were collected and CSS was applied again. After the 6-week Reiki application, all the caregivers of the intervention group were asked about their experience and opinions regarding the application by the individual in-depth interview method during the home visit.

Four student nurses who did not receive Reiki training and were trained about application by the investigator applied sham by gesturing and mimic imitation through touching 9 points for 45 minutes/week for 6 weeks in line. A saliva sample was taken from the participants in order to determine the stress level through cortisol and Caregiver Stress Scale (CSS) was applied in the first week of Reiki application. Systolic and diastolic blood pressures and pulse rates were measured for six weeks before and after each application. At the end of six weeks, saliva samples were collected and CSS was applied again.

Sham reiki by gesturing and mimic imitation through touching

Ulviye Özcan Yüce

Stress caused by late-identified and unmet needs of caregivers negatively affect the physical and emotional health of patients and caregivers as well as their compliance with the treatment. Therefore, it is necessary to evaluate the problems experienced by caregivers and to plan a number of attempts to reduce stress levels. Complementary and integrated practices for caregivers to manage their stresses are increasingly preferred approaches in recent years for many different reasons. One of these integrative practices, Reiki, is an energy therapy involving the use of energy that flows naturally from the hands of the practitioner to strengthen the body's ability to heal itself in order to increase well-being. This study was conducted using a pre-test and post-test, single-blind randomized controlled trial pattern and semi-structured in-depth interview method of qualitative research in order to evaluate the effect of Reiki on stress levels applied to individuals caring for cancer patients. The study comprised 42 women who were primary caregivers of cancer patients in total, as 21 women in Reiki group and 21 women in sham Reiki group. The approval of ethics committee, permissions from the institutions, and informed voluntary approval of the individuals were obtained to conduct the research. The data of the research were collected through the application of Caregiver Stress Scale (CSS), form for care giver's opinions on Reiki experience and application monitoring form including cortisol levels analyzed from saliva samples collected before and after application and measurements of pulse rate and blood pressure values. While Reiki group received reiki to 9 main points for 45 minutes per day for 6 weeks, in the sham Reiki group the same points were touched during the same period without starting energy flow. Caregiver Stress Scale (CSS) and salivary cortisol level were evaluated at the baseline and end of the study, whereas systolic and diastolic blood pressure and pulse rate were evaluated before and after application every week. At the end of the study, the opinions of the Reiki group on Reiki experience were collected by using a form consisting of semi-structured questions. The value of p\<0.05 was accepted statistically significant in the data analyses. Descriptive and content analysis methods were used to evaluate the qualitative data.

In this study, women who care for cancer patients received reiki to 9 main points including 7 chakra as well as ankle and feet for 45 minutes once a week for 6 weeks to determine its effect on stress level using a pretest-posttest randomized controlled single-blind study design of quantitative trial and semi-structured in-depth interview method of qualitative trial.The study was conducted in the medical oncology unit of a university hospital in Turkey. The data collection process continued from August 2018 to April 2019 and was reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. To be included in the study, a total of 86 caregivers were directed to the investigator by the charge nurse of the chemotherapy unit. The investigator evaluated the criteria for inclusion into study by conducting a preliminary interview with the directed caregivers. A total of 86 caregivers were evaluated; 61 were found eligible for the study and 51 caregivers agreed to participate into the study. Caregivers were assigned to reiki and sham reiki groups. One caregiver in the Reiki group was excluded from the study on the first application day because he/she could not provide a saliva sample. 4 of the caregivers in the sham reiki group did not continue their application appointments after the first week, and 4 of the caregivers in the sham reiki group left the study stating that they did not want to continue due to the deterioration in prognosis of the caretakers. The study was completed with a total of 42 caregivers

The study was conducted using a pre-test and post-test, single-blind randomized controlled trial pattern and semi-structured in-depth interview method of qualitative research.

The patients of the caregivers who met the study criteria were listed according to the protocol numbers and the participants were assigned to the reiki and sham reiki groups using simple random sampling method by the charge nurse of the chemotherapy unit. Thus, the participants were blinded to the intervention and placebo groups.

Considering the privacy concerns that the reiki, which is applied by touch, can cause the participants, it is preferred that the participants are women like the practitioners.

The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients

The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients: Qualitative and Single-blind Randomized Controlled Trial

The Caregiver Stress Scale (CSS) was developed by Robinson (1983) and is a tool that can be used to quickly identify families with potential care concerns. The scale consists of 13 items, which are answered "yes", "no". The main issues are job status, financial situation, physical condition, social status and time. The lowest score that can be obtained from the scale is "0" and the highest score is "13". The positive response to 7 or more items on the scale (7 points and above) indicates that stress is perceived high by the caregiver. In his study, Robinson has obtained a cronbach alpha value of 0.86. Validity and reliability of the Turkish version of the scale was performed by Uğur (2006) and the cronbach alpha value of the scale was calculated as 0.75.

Saliva samples were collected by a saliva cortisol tube, the amount of cortisol in saliva was measured by electrochemiluminescence immunological test (ECLIA) method using a specific device in the external laboratory. Taking into account that the production of peak cortisol is early in the morning, the samples were collected between 06:00 and 10:00, the reference value for this time interval is \<0.874 ug/dL

It includes stimuli of the sympathetic nervous system, such as physiological stress response to emotional stress, high blood pressure and increased pulse rate. Studies show that reiki stimulates parasympathetic activity and balances systolic and diastolic blood pressure and pulse rate. In the light of this information in this study blood pressure (systolic and diastolic blood pressure in mmHg) measurements performed before and after each application were measured three times at five-minute intervals and the mean value of three measurements recorded to minimize variations between measurements.

In order to reveal the retarding effects of Reiki on the pulse rate, similar to its effects on blood pressure, the pulse rate (beats per min) of individuals was measured three times at five-minute intervals and the average value of three measurements was recorded to minimize differences between measurements.

It was created in line with the literature in order to get the experience and opinions of the individuals after Reiki application in the reiki group by the individual in-depth interview method. In this form, there are semi-structured questions under the titles of caregivers' "thoughts on the reiki application", "thoughts on the application of reiki to patients they care for in order to reduce the stress level", "thoughts on the application of reiki by the nurses to patients they care for during their hospitalization". While the questions in the form were being structured, the investigator consulted an expert on sociology regarding the themes created from the given answers and the integrity of the expression.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reiki for Cancer: Pain, Anxiety, and Stress	NCT06296680	Therapeutic Tou... Cancer	Reiki Sham Reiki Progressive Rel...	18 Years - 90 Years	Ege University
The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients	NCT04461873	Caregiver Stres... Reiki Caregiver Burno...	Reiki Sham Reiki	18 Years -	TC Erciyes University
Reiki for Cancer: Pain, Anxiety, and Stress	NCT06296680	Therapeutic Tou... Cancer	Reiki Sham Reiki Progressive Rel...	18 Years - 90 Years	Ege University

Spots Global Cancer Trial Database for sham reiki

Every month we try and update this database with for sham reiki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sham reiki

Every month we try and update this database with for sham reiki cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sham reiki cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.