Clinical trial NCT04461873: The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients
Official title: The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients: Qualitative and Single-blind Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregiver Stress Syndrome
Reiki
Caregiver Burnout
Keywords: Care
Stress
Reiki
Nursing
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 42
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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

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

Primary outcomes:
measure: Caregiver Stress Scale (CSS)
timeFrame: Change from baseline score at the end of the sixth week
measure: Evaluation of Saliva Cortisol
timeFrame: Change from baseline score at the end of the sixth week
measure: Application Monitoring Form for Blood Pressure
timeFrame: Change from before and after each application and from the first week to the sixth week
measure: Application Monitoring Form for Pulse Rate
timeFrame: Change from before and after each application and from the first week to the sixth week
measure: Form for Care Giver's Opinions on Reiki Experience
timeFrame: At the end of the sixth week of Reiki intervation
Secondary outcomes:
Other outcomes:
Locations:
city: Osmaniye
country: Turkey
facility: Osmaniye Korkut Ata University
Study officials:
affiliation: Osmaniye Korkut Ata Üniversitesi
name: Ulviye Özcan Yüce
role: PRINCIPAL_INVESTIGATOR
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