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

NCT ID: NCT04461873

Last Updated: 2020-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-06
• Study Completion Date: 2019-04-06

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.

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

Conditions

Caregiver Stress Syndrome; Reiki; Caregiver Burnout

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Reiki

Intervention Type: OTHER

Reiki by touching

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.

Group Type: PLACEBO_COMPARATOR

Sham Reiki

Intervention Type: OTHER

Sham reiki by gesturing and mimic imitation through touching

Interventions

Reiki

Reiki by touching

Intervention Type: OTHER

Sham Reiki

Sham reiki by gesturing and mimic imitation through touching

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

TC Erciyes University

OTHER

Sponsor Role: lead

Responsible Party

Ulviye ÖZCAN YÜCE

Lecturer doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ulviye Özcan Yüce

Role: PRINCIPAL_INVESTIGATOR

Osmaniye Korkut Ata Üniversitesi

Locations

Osmaniye Korkut Ata University

Osmaniye, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

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Other Identifiers

TDK-2018-8030

Identifier Type: -

Identifier Source: org_study_id