Clinical trial NCT05483842: Reiki Effects on Heart Rhythm, Biochemistry and Cortisol Findings, and Anxiety
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Heart Diseases
Keywords: Reiki
Heart Rhythm
Arrythmia
Anxiety
Lead sponsor: Ankara Medipol University
Sponsor class: OTHER
First posted: 2022-08-02
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from Sodium values at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Potassium values at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Calcium values at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Magnesium values at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Baseline Cortisol at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Baseline Heart Rhythm at a week
timeFrame: -Within 1 hour of first admission. -A week later.
measure: Change from Baseline Beck Anxiety Scale at a week
timeFrame: -Within 1 hour of first admission. -A week later.
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Nursemin Ünal
state: None Selected
Study officials:
affiliation: Ankara Medipol University
name: Nilay BEKTAS AKPINAR, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
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.
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.
citation: 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.