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Trial Title: The Effect of Reiki on Symptom Control and Quality of Life in Breast Cancer Patients

NCT ID: NCT05684458

Condition: Breast Cancer
Symptoms and Signs
Quality of Life

Conditions: Official terms:
Breast Neoplasms

Conditions: Keywords:
Reiki
breast cancer
symptom control
quality of life

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: Single (Outcomes Assessor)

Masking description: The patients and the investigators know which group they are assigned to. Only the outcome assessor doesn't know which patient is assigned to which group.

Intervention:

Intervention type: Procedure
Intervention name: Reiki
Description: Reiki, a non-invasive, free and safe complementary therapy method, is practiced with a series of hand positions held on the patient's body to help balance the life force energy.
Arm group label: Reiki Group

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.

Criteria for 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.

Gender: Female

Gender based: Yes

Gender description: Only female patients with breast cancer will be included in the study.

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: February 1, 2023

Completion date: August 31, 2023

Lead sponsor:
Agency: Ankara Medipol University
Agency class: Other

Source: Ankara Medipol University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05684458

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