AnxietyNCT05483842
Reiki Effects on Heart Rhythm, Biochemistry and Cortisol Findings, and Anxiety
A study testing Reiki in people with Anxiety and Heart Diseases, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety, Heart Diseases
- What is being tested?
- Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 13 Apr 2022to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Reiki practitioner or trainer,
- Have received energy therapies such as Reiki/therapeutic touch,
- Patients who were diagnosed with another disease during the research process.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Anxiety, Heart Diseases
- Being tested
- Reiki, Sham Reiki
- Keywords
- Reiki, Heart Rhythm, Arrythmia, Anxiety
- Medical subject headings
- Anxiety Disorders, Heart Diseases, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Sham ReikiOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Sodium values at a week
In this section, there is Sodium value required for the normal electrical activity of the heart.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -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.
Measured: -Within 1 hour of first admission. -A week later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start13 Apr 2022
- Primary completion30 Jun 2022
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Medipol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NURSEMIN UNAL, Ankara Medipol University
- Investigators
- Nilay BEKTAS AKPINAR, PhD, Principal investigator, Ankara Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483842
- Sponsor's protocol ID
- E.60364
- Status last verified
- Jul 2022
- First submitted
- 29 Jul 2022
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 14639776Rao 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.
PubMed 27863608Thrane 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.
PubMed 24582620McManus 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.
PubMed 28874060Morero 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.
PubMed 34115737Bat 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.
PubMed 33639516Bektas 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.
PubMed 38652801
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05483842
- Acronym / sponsor ID
- E.60364
- Conditions
- Anxiety, Heart Diseases
- Keywords
- Reiki, Heart Rhythm, Arrythmia, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ankara Medipol UniversityUniversity, hospital or other
- Study start
- 13 Apr 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 2 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Reiki Group | Experimental | Other: ReikiPersonal 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. |
| Sham Reiki Group | Placebo comparator | Other: Sham ReikiPersonal 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Reiki practitioner or trainer,
- Have received energy therapies such as Reiki/therapeutic touch,
- Patients who were diagnosed with another disease during the research process.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ReikiConsisting 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. | Other | Reiki Group |
| Sham ReikiSham 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. | Other | Sham Reiki Group |
Primary outcome
Change from Sodium values at a week
Time frame: -Within 1 hour of first admission. -A week later.
In this section, there is Sodium value required for the normal electrical activity of the heart.
Change from Potassium values at a week
Time frame: -Within 1 hour of first admission. -A week later.
In this section, there is Potassium value required for the normal electrical activity of the heart.
Change from Calcium values at a week
Time frame: -Within 1 hour of first admission. -A week later.
In this section, there is Calcium value required for the normal electrical activity of the heart.
Change from Magnesium values at a week
Time frame: -Within 1 hour of first admission. -A week later.
In this section, there is Magnesium value required for the normal electrical activity of the heart.
Change from Baseline Cortisol at a week
Time frame: -Within 1 hour of first admission. -A week later.
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
Time frame: -Within 1 hour of first admission. -A week later.
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
Time frame: -Within 1 hour of first admission. -A week later.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Background: PubMed 14639776Gallob 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.
- Background: PubMed 27863608Rao 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.
- Background: PubMed 24582620Thrane 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.
- Background: PubMed 28874060McManus 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.
- Background: PubMed 34115737Morero 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.
- Background: PubMed 33639516Bat 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.
- Derived from this study: PubMed 38652801Bektas 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nilay BEKTAS AKPINAR, PhD principal investigator
Ankara Medipol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reiki in people with Anxiety and Heart Diseases, run by Ankara Medipol University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Sodium values at a week (time frame: -Within 1 hour of first admission. -A week later.). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05483842, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2022.