NCT05483842

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable anxiety

Timeline
Completed

Started Apr 2022

Shorter than P25 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 25, 2022

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 29, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2022

Completed
Last Updated

August 2, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 29, 2022

Last Update Submit

July 29, 2022

Conditions

Keywords

ReikiHeart RhythmArrythmiaAnxiety

Outcome Measures

Primary Outcomes (7)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Study Arms (3)

Reiki Group

EXPERIMENTAL

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.

Other: Reiki

Sham Reiki Group

PLACEBO COMPARATOR

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.

Other: Sham Reiki

Control Group

NO INTERVENTION

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.

Interventions

ReikiOTHER

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.

Reiki Group

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.

Sham Reiki Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Reiki practitioner or trainer,
  • Have received energy therapies such as Reiki/therapeutic touch,
  • Patients who were diagnosed with another disease during the research process.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nursemin Ünal

Ankara, None Selected, 06050, Turkey (Türkiye)

Location

Related Publications (7)

  • 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.

    PMID: 14639776BACKGROUND
  • 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.

    PMID: 27863608BACKGROUND
  • 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.

    PMID: 24582620BACKGROUND
  • 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.

    PMID: 28874060BACKGROUND
  • 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.

    PMID: 34115737BACKGROUND
  • 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.

    PMID: 33639516BACKGROUND
  • Bektas Akpinar N, Ozcan Yuce U, Cansiz G, Yurtsever D, Ozkanat C, Unal N, Sabanoglu C, Altinbas Akkas O, Yurtsever S. Is Reiki effective in reducing heart rhythm, cortisol levels, and anxiety and improving biochemical parameters in individuals with cardiac disease? Randomized placebo-controlled trial. Eur J Cardiovasc Nurs. 2024 Oct 21;23(7):771-779. doi: 10.1093/eurjcn/zvae051.

MeSH Terms

Conditions

Anxiety DisordersHeart DiseasesArrhythmias, Cardiac

Interventions

Therapeutic Touch

Condition Hierarchy (Ancestors)

Mental DisordersCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual Therapies

Study Officials

  • Nilay BEKTAS AKPINAR, PhD

    Ankara Medipol University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The patients did not know which group they were assigned to.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 29, 2022

First Posted

August 2, 2022

Study Start

April 13, 2022

Primary Completion

June 30, 2022

Study Completion

July 25, 2022

Last Updated

August 2, 2022

Record last verified: 2022-07

Locations