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

NCT05684458 | Unknown

• 1 other identifier: 114
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer; Symptoms and Signs; Quality of Life

Keywords

Reiki; breast cancer; symptom control; quality of life

Outcome Measures

Primary Outcomes (3)

• Patient Descriptive Information Form

  The form created by the researchers included 11 questions covering the sociodemographic and medical characteristics.

  Baseline

• 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 α value of ESAS was 0.83; Cronbach's α ESAS after chemotherapy is 0.76.

  Change from baseline Edmonton Symptom Diagnosis Scale at 3rd days and 10th days

• 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

Study Arms (2)

Reiki Group

EXPERIMENTAL

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) will be administered to the Reiki group. Then, 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. After 3 days and 10 days after the patients were included in the study, the post-tests will be performed by calling the patients.

Procedure: Reiki

Control Group

NO INTERVENTION

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) will be administered to the control group. No treatment will be applied to the patients. Post-tests will be applied to all patients 3 days and 10 days after they were included in the study.

Interventions

Reiki PROCEDURE

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.

Reiki Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only female patients with breast cancer will be included in the study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ankara Medipol University: lead

Related Publications (6)

• 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.

  PMID: 28595441 BACKGROUND

• 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.

  PMID: 1714502 BACKGROUND

• 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.

  PMID: 8433390 BACKGROUND

• 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.

  PMID: 30319064 BACKGROUND

• 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.

  PMID: 27587296 BACKGROUND

• 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.

  PMID: 32778391 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Signs and Symptoms

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies

Study Officials

• Nursemin Unal

  Ankara Medipol University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nursemin Unal

CONTACT

+905077433629; nurse_unal@hotmail.com

Nilay Bektaş Akpınar

CONTACT

+905319920260; nilay.bektasakpinar@ankaramedipol.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 5, 2023
• First Posted: January 13, 2023
• Study Start: February 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: August 31, 2023
• Last Updated: January 13, 2023

Record last verified: 2023-01