Clinical trial NCT05684458: The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients
Official title: The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Symptoms and Signs
Quality of Life
Keywords: Reiki
breast cancer
symptom control
quality of life
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2023-01-13
Enrollment: 52
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this study is to examine the effect of Reiki on symptom control and quality of life in breast cancer patients.

Detailed description: Breast cancer is the world's second most common type of cancer, the most frequently diagnosed cancer in women, and the leading cause of cancer death. Energy therapies have an essential place in complementary and alternative treatments that are commonly used in breast cancer patients. Reiki, practiced by trained practitioners, is performed by activating the body's energy centers, including blood and lymph circulation, and stimulating the nervous system, thus providing energy circulation and providing mental-physical relaxation, positively affecting health. The effect of Reiki on cancer patients has been shown in studies that it can relieve pain, reduce anxiety and depression, improve quality of life and reduce fatigue.

In this study, women with stage 3 and 4 metastatic breast cancer who were diagnosed with breast cancer for at least 3 months and received at least two cycles of chemotherapy in the outpatient chemotherapy unit of the Medical Oncology outpatient clinic of a training and research hospital will be included. It is aimed to reach a total of 52 women who meet the inclusion criteria and agreed to participate in the study between February 1, 2023, and July 30, 2023. Patient Descriptive Information Form, Edmonton Symptom Diagnosis Scale (ESTO), and European Association for Cancer Research and Treatment BR23 Quality of Life Scale (EORTC-QLQ-BR232) preliminary tests will be applied to all women. Patients will be randomized 1:1 into groups by a single therapist according to the block randomization method. Under the guidance of a researcher holding a Usui Reiki Master \& Teacher degree, a total of 26 patients in the intervention group will be given a short 30-minute application to energy centers by researchers with a second-degree Reiki practitioner. On the second and on third days, 30 minutes of short Reiki will be done remotely. No treatment will be applied to 26 patients in the control group. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

Eligibility criteria: Inclusion Criteria:

* Women with at least 3 months of breast cancer diagnosis, at least two cycles of chemotherapy, and stage 3 and 4 metastatic breast cancer.

Exclusion Criteria:

* Those who have difficulty in responding to the data collection form to be used in the research and have problems in understanding and communicating Turkish,
* Those who refuse to answer the Reiki application and data collection tools,
* Those who want to leave the research while the research is continuing,
* Those who received any supplementary application in the last 6 months will be excluded from the study.

Primary outcomes:
measure: Patient Descriptive Information Form
timeFrame: Baseline
measure: Change from Edmonton Symptom Diagnosis Scale
timeFrame: Change from baseline Edmonton Symptom Diagnosis Scale at 3rd days and 10th days
measure: Change from European Association for Cancer Research and Treatment BR23 Quality of Life Scale
timeFrame: Change from baseline European Association for Cancer Research and Treatment BR23 Quality of Life Scale at 3rd days and 10th days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ankara Medipol University
name: Nursemin Unal
role: PRINCIPAL_INVESTIGATOR
References:
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