The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients

Caregiver Burnout Clinical Trial

Official title:

The Effect of Reiki on the Stress Level of Caregivers of Cancer Patients: Qualitative and Single-blind Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04461873
• Other study ID #: TDK-2018-8030
• Status: Completed
• Phase: N/A
• Start date: August 6, 2018
• Est. completion date: April 6, 2019

Study information

• Verified date: July 2020
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: April 6, 2019
• Est. primary completion date: November 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout, Psychological
• Caregiver Burnout
• Caregiver Stress Syndrome
• Reiki

Intervention

Other:
• Reiki
Reiki by touching
• Sham Reiki
Sham reiki by gesturing and mimic imitation through touching

Locations

Country	Name	City	State
Turkey	Osmaniye Korkut Ata University	Osmaniye

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Country where clinical trial is conducted

Turkey, 

References & Publications (18)

Akmansu M. Integrative oncology. Turk J Oncology. 2019;34(1):56-58.

Buckley TM, Schatzberg AF. On the interactions of the hypothalamic-pituitary-adrenal (HPA) axis and sleep: normal HPA axis activity and circadian rhythm, exemplary sleep disorders. J Clin Endocrinol Metab. 2005 May;90(5):3106-14. Epub 2005 Feb 22. Review. — View Citation

Cassidy N, Collins K, Cyr D, Magni K. The effect of Reiki on women's preoperative anxiety in an ambulatory surgery center. Journal of PeriAnesthesia Nursing, 2010; 25 (3): 196-198.

Chang HY, Chiou CJ, Chen NS. Impact of mental health and caregiver burden on family caregivers' physical health. Arch Gerontol Geriatr. 2010 May-Jun;50(3):267-71. doi: 10.1016/j.archger.2009.04.006. Epub 2009 May 13. — View Citation

Dissiz G, Yilmaz M. Complementary and alternative therapies and health literacy in cancer patients. Complement Ther Clin Pract. 2016 May;23:34-9. doi: 10.1016/j.ctcp.2016.02.004. Epub 2016 Mar 2. — View Citation

Friedman RS, Burg MM, Miles P, Lee F, Lampert R. Effects of Reiki on autonomic activity early after acute coronary syndrome. J Am Coll Cardiol. 2010 Sep 14;56(12):995-6. doi: 10.1016/j.jacc.2010.03.082. — View Citation

Lopez G, Mao JJ, Cohen L. Integrative Oncology. Med Clin North Am. 2017 Sep;101(5):977-985. doi: 10.1016/j.mcna.2017.04.011. Epub 2017 Jun 23. Review. — View Citation

Mackay N, Hansen S, McFarlane O. Autonomic nervous system changes during Reiki treatment: a preliminary study. J Altern Complement Med. 2004 Dec;10(6):1077-81. — View Citation

Musal N. Applied reiki handbook for first degree. Istanbul:Akis Yayincilik; 2008.

Olson K, Hanson J, Michaud M. A phase II trial of Reiki for the management of pain in advanced cancer patients. J Pain Symptom Manage. 2003 Nov;26(5):990-7. — View Citation

Salles LF, Vannucci L, Salles A, Silva MJP. The effect of Reiki on blood hypertension. Acta Paul Enferm. 2014; 27(5):479-84.

Tekin HH. In-depth interview of qualitative research method as a data collection technique. Istanbul Üniversitesi Sosyoloji Dergisi 2006;3(13): 101 - 116.

Tsigos C, Chrousos GP. Hypothalamic-pituitary-adrenal axis, neuroendocrine factors and stress. J Psychosom Res. 2002 Oct;53(4):865-71. Review. — View Citation

Ugur Ö. Examination of care burden of caregivers of oncology patients. Ege University: Health Sciences Institute, Ph.D. Thesis, Izmir: 2006

Vogeser M, Kratzsch J, Ju Bae Y, Bruegel M, Ceglarek U, Fiers T, Gaudl A, Kurka H, Milczynski C, Prat Knoll C, Suhr AC, Teupser D, Zahn I, Ostlund RE. Multicenter performance evaluation of a second generation cortisol assay. Clin Chem Lab Med. 2017 May 1;55(6):826-835. doi: 10.1515/cclm-2016-0400. — View Citation

Witt CM, Balneaves LG, Cardoso MJ, Cohen L, Greenlee H, Johnstone P, Kücük Ö, Mailman J, Mao JJ. A Comprehensive Definition for Integrative Oncology. J Natl Cancer Inst Monogr. 2017 Nov 1;2017(52). doi: 10.1093/jncimonographs/lgx012. — View Citation

Yildiz E, Dedeli Ö, Pakyüz SÇ. Evaluation of Care Burden and Quality of Life among Family Caregivers of Patients with Cancer. Hemsirelikte Egitim Ve Arastirma Dergisi, 2016;13 (3): 216-225. doi:10.5222/HEAD.2016.216.

Yüce UÖ, Atik D, Karatepe HK, Erdogan Z, Cosar AA. Reiki Reiki and Diabetes. Acta Med. Alanya 2017;1(2): 49-53.

* Note: There are 18 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caregiver Stress Scale (CSS)	The Caregiver Stress Scale (CSS) was developed by Robinson (1983) and is a tool that can be used to quickly identify families with potential care concerns. The scale consists of 13 items, which are answered "yes", "no". The main issues are job status, financial situation, physical condition, social status and time. The lowest score that can be obtained from the scale is "0" and the highest score is "13". The positive response to 7 or more items on the scale (7 points and above) indicates that stress is perceived high by the caregiver. In his study, Robinson has obtained a cronbach alpha value of 0.86. Validity and reliability of the Turkish version of the scale was performed by Ugur (2006) and the cronbach alpha value of the scale was calculated as 0.75.	Change from baseline score at the end of the sixth week
Primary	Evaluation of Saliva Cortisol	Saliva samples were collected by a saliva cortisol tube, the amount of cortisol in saliva was measured by electrochemiluminescence immunological test (ECLIA) method using a specific device in the external laboratory. Taking into account that the production of peak cortisol is early in the morning, the samples were collected between 06:00 and 10:00, the reference value for this time interval is <0.874 ug/dL	Change from baseline score at the end of the sixth week
Primary	Application Monitoring Form for Blood Pressure	It includes stimuli of the sympathetic nervous system, such as physiological stress response to emotional stress, high blood pressure and increased pulse rate. Studies show that reiki stimulates parasympathetic activity and balances systolic and diastolic blood pressure and pulse rate. In the light of this information in this study blood pressure (systolic and diastolic blood pressure in mmHg) measurements performed before and after each application were measured three times at five-minute intervals and the mean value of three measurements recorded to minimize variations between measurements.	Change from before and after each application and from the first week to the sixth week
Primary	Application Monitoring Form for Pulse Rate	In order to reveal the retarding effects of Reiki on the pulse rate, similar to its effects on blood pressure, the pulse rate (beats per min) of individuals was measured three times at five-minute intervals and the average value of three measurements was recorded to minimize differences between measurements.	Change from before and after each application and from the first week to the sixth week
Primary	Form for Care Giver's Opinions on Reiki Experience	It was created in line with the literature in order to get the experience and opinions of the individuals after Reiki application in the reiki group by the individual in-depth interview method. In this form, there are semi-structured questions under the titles of caregivers' "thoughts on the reiki application", "thoughts on the application of reiki to patients they care for in order to reduce the stress level", "thoughts on the application of reiki by the nurses to patients they care for during their hospitalization". While the questions in the form were being structured, the investigator consulted an expert on sociology regarding the themes created from the given answers and the integrity of the expression.	At the end of the sixth week of Reiki intervation