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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05684458
• Other study ID #: 114
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: August 31, 2023

Study information

• Verified date: January 2023
• Source: Ankara Medipol University
• Contact: Nursemin Unal
• Phone: +905077433629
• Email: nurse_unal[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: August 31, 2023
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Quality of Life
• Symptoms and Signs

Intervention

Procedure:
• Reiki
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Medipol University

References & Publications (6)

Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365. — View Citation

Bruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9. — View Citation

Buyukbayram Z, Citlik Saritas S. The effect of Reiki and guided imagery intervention on pain and fatigue in oncology patients: A non-randomized controlled study. Explore (NY). 2021 Jan-Feb;17(1):22-26. doi: 10.1016/j.explore.2020.07.009. Epub 2020 Jul 31. — View Citation

Frisch N, Butcher HK, Campbell D, Weir-Hughes D. Holistic Nurses' Use of Energy-Based Caring Modalities. J Holist Nurs. 2018 Sep;36(3):210-217. doi: 10.1177/0898010116665447. Epub 2016 Sep 1. — View Citation

Ong'udi M, Mutai P, Weru I. Study of the use of complementary and alternative medicine by cancer patients at Kenyatta National Hospital, Nairobi, Kenya. J Oncol Pharm Pract. 2019 Jun;25(4):918-928. doi: 10.1177/1078155218805543. Epub 2018 Oct 14. — View Citation

Steinhorn DM, Din J, Johnson A. Healing, spirituality and integrative medicine. Ann Palliat Med. 2017 Jul;6(3):237-247. doi: 10.21037/apm.2017.05.01. Epub 2017 May 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Descriptive Information Form	The form created by the researchers included 11 questions covering the sociodemographic and medical characteristics.	Baseline
Primary	Change from Edmonton Symptom Diagnosis Scale	It was developed by Bruera et al. in 1991. Ten symptoms are questioned as pain, fatigue, nausea, sadness, anxiety, insomnia, loss of appetite, well-being, shortness of breath and other problems. In the Turkish validity and reliability study of the scale, 3 additional symptoms (changes in the skin and nails, sores in the mouth, numbness in the hands) were added to the other problems section in line with the literature information. The patient is asked to match his symptoms with a number that he thinks is most suitable for him from the numbers from 0 to 10. The number 0 indicates no symptoms, the number 10 indicates that the symptom is very severe. Pre-chemotherapy Cronbach a value of ESAS was 0.83; Cronbach's a ESAS after chemotherapy is 0.76.	Change from baseline Edmonton Symptom Diagnosis Scale at 3rd days and 10th days
Primary	Change from European Association for Cancer Research and Treatment BR23 Quality of Life Scale	The scale is a quality of life scale specially prepared for breast cancer by the European Cancer Research and Treatment Organization. It can be applied to all breast cancer patients, regardless of the stage of the disease and the treatment method. Its Turkish validity and reliability were evaluated by Demirci et al. in 2011. and the Cronbach alpha value was found to be 0.90. This scale is divided into two subgroups as functional and symptom scales. Scoring is made as 1 (none)-4 (very much). Higher functional dimension scores indicate higher quality of life. A high score in the symptoms dimension indicates a low quality of life, and low scores indicate a high quality of life.	Change from baseline European Association for Cancer Research and Treatment BR23 Quality of Life Scale at 3rd days and 10th days