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

Sponsor

TC Erciyes University (Other)

Overall Status

Completed

CT.gov ID

NCT04461873

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

5.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Stress Syndrome Reiki Caregiver Burnout	Other: Reiki Other: Sham Reiki	N/A

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

42 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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 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.

Masking:

Single (Participant)

Masking Description:

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.

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Aug 6, 2018

Actual Primary Completion Date :

Nov 15, 2018

Actual Study Completion Date :

Apr 6, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Reiki 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.	Other: Reiki Reiki by touching
Placebo Comparator: Sham Reiki 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.	Other: Sham Reiki Sham reiki by gesturing and mimic imitation through touching

Arm

Intervention/Treatment

Experimental: Reiki

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.

Other: Reiki

Reiki by touching

Placebo Comparator: Sham Reiki

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.

Other: Sham Reiki

Sham reiki by gesturing and mimic imitation through touching

Outcome Measures

Primary Outcome Measures

Caregiver Stress Scale (CSS) [Change from baseline score at the end of the sixth week]
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.
Evaluation of Saliva Cortisol [Change from baseline score at the end of the sixth week]
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
Application Monitoring Form for Blood Pressure [Change from before and after each application and from the first week to the sixth week]
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.
Application Monitoring Form for Pulse Rate [Change from before and after each application and from the first week to the sixth week]
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.
Form for Care Giver's Opinions on Reiki Experience [At the end of the sixth week of Reiki intervation]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Being over 18 years old and female
Can communicate
Being a primary caregiver family member of cancer patients receiving treatment,
Providing care to the patient for 8 hours / day for at least 6 months, and Caregiver Stress Scale (CSS) score of 7 and above

Exclusion Criteria:

To provide maintenance service for a fee,
Having another medical problem that will prevent pulse rate and blood pressure measurement,
Pulse rate to be variable,
Being unable to give a saliva secretion due to other medical problems,
Using cortisol and its derivative drugs,
Having a history of psychiatric disorders,
Being a Reiki practitioner or trainer,
To have received energy therapies such as Reiki / Therapeutic touch / Healing touch,
To use other complementary and integrated medicine applications

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Osmaniye Korkut Ata University	Osmaniye		Turkey	80000

Sponsors and Collaborators

TC Erciyes University

Investigators

Principal Investigator: Ulviye Özcan Yüce, Osmaniye Korkut Ata Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Ulviye ÖZCAN YÜCE, Lecturer doctor, TC Erciyes University

ClinicalTrials.gov Identifier:

NCT04461873

Other Study ID Numbers:

TDK-2018-8030

First Posted:

Jul 8, 2020

Last Update Posted:

Jul 8, 2020

Last Verified:

Jul 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ulviye ÖZCAN YÜCE, Lecturer doctor, TC Erciyes University

Additional relevant MeSH terms:

Caregiver Burden

Study Results

No Results Posted as of Jul 8, 2020