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

Primary Purpose

Anxiety, Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Reiki
Sham Reiki
Sponsored by
Ankara Medipol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety focused on measuring Reiki, Heart Rhythm, Arrythmia, Anxiety

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nursemin Ünal

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

No Intervention

Arm Label

Reiki Group

Sham Reiki Group

Control Group

Arm Description

Personal Information Form (PIF) and Beck Anxiety Scale (BAS) were administered to the Reiki group through face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After the pre-tests of the patients were completed, the application was made under the guidance of a researcher with a Usui Reiki Master & Teacher degree and by a researcher with Reiki II training. In accordance with the Reiki Practice Protocol, an empty and silent room was selected in the hospital. Reiki was applied one-on-one to energy centers (crown chakra, forehead chakra, throat chakra, heart chakra, solar plexus, sacral region, root chakra, knees, ankle and feet) for 30 minutes. On the second day, 30 minutes of distant Reiki was applied. BAS was administered 1 week later; ECG was taken and biochemistry blood was taken.

Personal Information Form (PIF) and Beck Anxiety Scale (Scale) were administered to this group by face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After the pre-tests of the patients were completed. The Sham Reiki group was practiced by a student nurse who did not receive Reiki training by imitating the hand positions used in Reiki practice. Before the applications, the researcher, the student was told about aura equalization and chakras, the student only imitated gestures and facial expressions, but did not give Reiki energy to the patients. BAS was administered 1 week later; ECG was taken and biochemistry blood was taken.

Personal Information Form (PIF) and Beck Anxiety Scale (BAS) were administered to this group by face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After 1 week, BAS, blood tests and ECG have applied again.

Outcomes

Primary Outcome Measures

Change from Sodium values at a week
In this section, there is Sodium value required for the normal electrical activity of the heart.
Change from Potassium values at a week
In this section, there is Potassium value required for the normal electrical activity of the heart.
Change from Calcium values at a week
In this section, there is Calcium value required for the normal electrical activity of the heart.
Change from Magnesium values at a week
In this section, there is Magnesium value required for the normal electrical activity of the heart.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 29, 2022
Last Updated
July 29, 2022
Sponsor
Ankara Medipol University
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1. Study Identification

Unique Protocol Identification Number
NCT05483842
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
April 13, 2022 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ankara Medipol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Heart Diseases
Keywords
Reiki, Heart Rhythm, Arrythmia, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The patients did not know which group they were assigned to.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reiki Group
Arm Type
Experimental
Arm Description
Personal Information Form (PIF) and Beck Anxiety Scale (BAS) were administered to the Reiki group through face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After the pre-tests of the patients were completed, the application was made under the guidance of a researcher with a Usui Reiki Master & Teacher degree and by a researcher with Reiki II training. In accordance with the Reiki Practice Protocol, an empty and silent room was selected in the hospital. Reiki was applied one-on-one to energy centers (crown chakra, forehead chakra, throat chakra, heart chakra, solar plexus, sacral region, root chakra, knees, ankle and feet) for 30 minutes. On the second day, 30 minutes of distant Reiki was applied. BAS was administered 1 week later; ECG was taken and biochemistry blood was taken.
Arm Title
Sham Reiki Group
Arm Type
Placebo Comparator
Arm Description
Personal Information Form (PIF) and Beck Anxiety Scale (Scale) were administered to this group by face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After the pre-tests of the patients were completed. The Sham Reiki group was practiced by a student nurse who did not receive Reiki training by imitating the hand positions used in Reiki practice. Before the applications, the researcher, the student was told about aura equalization and chakras, the student only imitated gestures and facial expressions, but did not give Reiki energy to the patients. BAS was administered 1 week later; ECG was taken and biochemistry blood was taken.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Personal Information Form (PIF) and Beck Anxiety Scale (BAS) were administered to this group by face-to-face interviews. Then, blood was taken for biochemical blood and cortisol findings and ECG was taken. After 1 week, BAS, blood tests and ECG have applied again.
Intervention Type
Other
Intervention Name(s)
Reiki
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Sham Reiki
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Sodium values at a week
Description
In this section, there is Sodium value required for the normal electrical activity of the heart.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Potassium values at a week
Description
In this section, there is Potassium value required for the normal electrical activity of the heart.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Calcium values at a week
Description
In this section, there is Calcium value required for the normal electrical activity of the heart.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Magnesium values at a week
Description
In this section, there is Magnesium value required for the normal electrical activity of the heart.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Baseline Cortisol at a week
Description
In addition, individuals with arrhythmia experience stress and have a blood cortisol value due to the relationship between stress and cortisol hormone.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Baseline Heart Rhythm at a week
Description
In order to determine cardiac arrhythmias, 12-lead ECG was taken from the individuals within the scope of the study.
Time Frame
-Within 1 hour of first admission. -A week later.
Title
Change from Baseline Beck Anxiety Scale at a week
Description
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.
Time Frame
-Within 1 hour of first admission. -A week later.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nilay BEKTAS AKPINAR, PhD
Organizational Affiliation
Ankara Medipol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nursemin Ünal
City
Ankara
State/Province
None Selected
ZIP/Postal Code
06050
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
14639776
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.
Results Reference
background
PubMed Identifier
27863608
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.
Results Reference
background
PubMed Identifier
24582620
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.
Results Reference
background
PubMed Identifier
28874060
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.
Results Reference
background
PubMed Identifier
34115737
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.
Results Reference
background
PubMed Identifier
33639516
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.
Results Reference
background

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

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