Reiki Effects on Heart Rhythm, Biochemistry and Cortisol Findings, and Anxiety

Anxiety Clinical Trial

Official title:

Effects of Reiki on Heart Rhythm, Biochemistry, Cortisol Findings and Anxiety in Individuals With Arrhythmia: A Randomized Prospective, Single-Blind and Placebo-Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05483842
• Other study ID #: E.60364
• Status: Completed
• Phase: N/A
• Start date: April 13, 2022
• Est. completion date: July 25, 2022

Study information

• Verified date: July 2022
• Source: Ankara Medipol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the effects of Reiki, which is a complementary and traditional method, on heart rhythm, biochemistry and cortisol findings, and anxiety in individuals with arrhythmia.

Description:

Reiki has an essential place in modern medicine and the nursing profession because it cures many diseases resistant to known treatments, has no side effects, is easy to apply, and is safe, effective, and economical. In the Reiki method, the energy is transferred through the hands, and a care provider nurse is a tool that performs their profession by touching in patient care and also shares the universal life energy, transferring the flowing and formed energy. When the literature is reviewed, there are a limited number of studies in which Reiki affects heart rate, cortisol level, and vital signs. However, there are not enough studies examining the effects of heart patients' symptoms, anxiety, and their condition on Reiki results. In this context, this study aimed to investigate the effects of Reiki energy on heart rhythm, biochemistry, cortisol findings, and anxiety in people with arrhythmia.

The study was conducted as a pretest-posttest, randomized prospective, single-blind and placebo-controlled. The study was conducted with patients who applied to a training and research hospital with arrhythmia complaints between April 5 and June 30, 2022. The data was collected using "Personal Information Form (PIF)" and "Beck Anxiety Scale (BAS)". Also, biochemical tests and cortisol findings and ECG (Electrocardiography) analyses were assessed.

PIF and BAS were applied to patients who agreed to participate in the study and met the inclusion criteria. Then blood was drawn for biochemical tests and cortisol findings and EKG was taken. Patients were randomized 1:1 into groups by a single therapist at a single institution according to a parallel design. There were three treatment arms in the study: Reiki treatment (n=22), Sham Reiki treatment (placebo)(n=22), and a control group with no treatment (n=22). A second-degree Reiki practitioner applied Reiki to the energy centers for 30 minutes in the Reiki group. On the second day, distant Reiki was also conducted for 30 minutes. The Sham Reiki group, on the other hand, was handled similarly to the Reiki practice by a student who had not been trained in Reiki. In the control group, nothing was done. One week later, BAS was applied to all patients, blood was drawn for biochemical testing and an ECG was recorded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 25, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age 18 and over

• No communication problem

• Diagnosed with cardiac arrhythmia

• Who agree to participate in the Reiki practice

• Who is competent to answer the data collection tools to be used in the research

• Patients who have not used complementary practices in the last six months

Exclusion Criteria:

• Reiki practitioner or trainer,

• Have received energy therapies such as Reiki/therapeutic touch,

• Patients who were diagnosed with another disease during the research process.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Heart Diseases

Intervention

Other:
• Reiki
Consisting of the words "rei" meaning "spirit" and "ki" meaning "universal life force", Reiki means spiritually directed life force energy. Reiki practice has an important place in modern medicine and the nursing profession because it cures many diseases resistant to known treatments, has no side effects, is easy to apply, is safe, effective and economical. In the Reiki method, which is one of the complementary and alternative methods, energy is transferred through the hands. Its basis is based on the principle that when there is a blockage in an energy center, disease occurs and the energy transferred by touching, strengthens and heals the body's self-healing ability by opening the blockages. Reiki practitioners who have received training and initiation perform the practice by holding their hands in certain positions on the recipient's body.
• Sham Reiki
Sham means to pretend; therefore, in this study, the sham Reiki placebo provider pretended to perform a Reiki session by moving her hands on the patient's body in a specific order for a 30-minute period following strictly operationalized measures.

Locations

Country	Name	City	State
Turkey	Nursemin Ünal	Ankara	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
Ankara Medipol University

Country where clinical trial is conducted

Turkey, 

References & Publications (6)

Bat N. The effects of reiki on heart rate, blood pressure, body temperature, and stress levels: A pilot randomized, double-blinded, and placebo-controlled study. Complement Ther Clin Pract. 2021 May;43:101328. doi: 10.1016/j.ctcp.2021.101328. Epub 2021 Feb 17. — View Citation

Gallob R. Reiki: a supportive therapy in nursing practice and self-care for nurses. J N Y State Nurses Assoc. 2003 Spring-Summer;34(1):9-13. Review. — View Citation

McManus DE. Reiki Is Better Than Placebo and Has Broad Potential as a Complementary Health Therapy. J Evid Based Complementary Altern Med. 2017 Oct;22(4):1051-1057. doi: 10.1177/2156587217728644. Epub 2017 Sep 5. Review. — View Citation

Morero JAP, Pereira SS, Esteves RB, Cardoso L. Effects of Reiki on Mental Health Care: A Systematic Review. Holist Nurs Pract. 2021 Jul-Aug 01;35(4):191-198. doi: 10.1097/HNP.0000000000000456. — View Citation

Rao A, Hickman LD, Sibbritt D, Newton PJ, Phillips JL. Is energy healing an effective non-pharmacological therapy for improving symptom management of chronic illnesses? A systematic review. Complement Ther Clin Pract. 2016 Nov;25:26-41. doi: 10.1016/j.ctcp.2016.07.003. Epub 2016 Aug 2. Review. — View Citation

Thrane S, Cohen SM. Effect of Reiki therapy on pain and anxiety in adults: an in-depth literature review of randomized trials with effect size calculations. Pain Manag Nurs. 2014 Dec;15(4):897-908. doi: 10.1016/j.pmn.2013.07.008. Epub 2014 Feb 28. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Sodium values at a week	In this section, there is Sodium value required for the normal electrical activity of the heart.	-Within 1 hour of first admission. -A week later.
Primary	Change from Potassium values at a week	In this section, there is Potassium value required for the normal electrical activity of the heart.	-Within 1 hour of first admission. -A week later.
Primary	Change from Calcium values at a week	In this section, there is Calcium value required for the normal electrical activity of the heart.	-Within 1 hour of first admission. -A week later.
Primary	Change from Magnesium values at a week	In this section, there is Magnesium value required for the normal electrical activity of the heart.	-Within 1 hour of first admission. -A week later.
Primary	Change from Baseline Cortisol at a week	In addition, individuals with arrhythmia experience stress and have a blood cortisol value due to the relationship between stress and cortisol hormone.	-Within 1 hour of first admission. -A week later.
Primary	Change from Baseline Heart Rhythm at a week	In order to determine cardiac arrhythmias, 12-lead ECG was taken from the individuals within the scope of the study.	-Within 1 hour of first admission. -A week later.
Primary	Change from Baseline Beck Anxiety Scale at a week	The scale measured the frequency of anxiety symptoms and signs experienced by the individual. The scale is a Likert-type scale consisting of 21 items and scores between 0-3. The minimum score to be taken from the scale is 0 and the maximum score is 63. As the score obtained from the scale increases, the anxiety of the individual increases.	-Within 1 hour of first admission. -A week later.