StressPhase 1NCT00346671
Effects of Reiki on Stress
A Phase 1 study testing Rest and Reiki in people with Stress, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for relaxation and pain management that involves physical touch and social contact with a trained, empathetic practitioner. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Rest and Reiki
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 257 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2010
- Phase
- Phase 1
- 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 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy Individuals between the age of 18 and 75
Who cannot join
- Already involved in regular (one time a week or more) mind-body practices (yoga, meditation, Qi-gong, guided imagery, Taichi, biofeedback; attendance at religious services is not considered a mind-body practice) in the past three months OR has been doing intense spiritual practice for more than 6 months in the past (an average of 6hrs a week)
- Already received an energy therapy treatment (Reiki, therapeutic touch, healing touch, touch therapy) in the past. (note: acupuncture, massage Qi-gong are not considered energy therapies in the context of this study)
- Score on the DASS21 for Depression greater or equal to 21
- Score on the DASS21 for Anxiety greater or equal to 15
- In the last 3 months, has had a major stressful life-event that is likely to affect the outcomes of the study
- Medical condition, current illness or history of chronic illness that might affect the outcomes of the study such as those affecting stress response, cardiovascular, endocrine, or immune systems (Examples: cancer, lupus, multiple sclerosis, blood-clotting disorder, severe allergies or asthma that impairs breathing, diabetes mellitus, hyperglycemia, or hypoglycemia, cardiovascular disease, depression/anxiety etc.)
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- In the past 3 months, has used or is chronically using over-the-counter, recreational or prescription drugs that might affect the outcomes of the study such as those affecting cardiovascular, platelets, central nervous system, endocrine, immune systems(Examples: steroid, blood pressure medication, depression/anxiety medication, antiplatelet drugs, etc.)
- Color Blind
- Consume 3 or more alcoholic drinks per day most days over the 3 months
- Pregnant
- Problems donating blood: Fear of hypodermic needles; has felt dizzy or was about to faint following a needle stick
- Incompatibility of energy healing with religious beliefs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Reiki on Physiological Consequences of Acute Stress
Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for relaxation and pain management that involves physical touch and social contact with a trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no participation by the patient, a feature that makes Reiki particularly attractive in the hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated. Our primary research questions are to determine whether physiological changes are induced during a Reiki session and whether a Reiki session affects responses to a subsequent acute stressor. Secondary research questions include assessing which benefits result from placebo or unique abilities of "attuned" Reiki practitioners and assessing background characteristics of recipients that are associated with acceptance and responsiveness. Based on its use to reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity of the sympathetic nervous system and other stress pathways. Comparison of the responses in a Reiki group with those in supine-control and sham groups will allow us to gain insights into mechanisms by which Reiki effects are mediated. Information obtained from the proposed studies will provide detailed information on physiological pathways affected by Reiki. Should Reiki decrease stress pathways or reduce physiological responses to stressful situations, it could be a useful adjunct to traditional medicine and have significant health and economic benefits.
Read the detailed description
See Brief Summary
- Conditions
- Stress
- Being tested
- Rest, Sham, Reiki
- Keywords
- Reiki, Stress, CAM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RestOther
30 min supine rest
ShamOther
Also called Touch, Pretend Reiki, Placebo Reiki
30 min session with Sham practitioner
ReikiOther
Also called Energy Healing, Energy Therapy, Touch Therapy
30 min session with Reiki practitioner
| Study group | Role | What they receive |
|---|---|---|
| Supine Rest | Placebo comparator | 30min supine rest listening to soft music Receives: Other: Rest |
| Sham Reiki | Sham comparator | 30 min intervention by sham practitioner Receives: Other: Sham |
| Reiki | Experimental | 30 min session with Reiki practitioner Receives: Other: Reiki |
What is being measured
The primary outcome is the main question the study is designed to answer.
1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity
Measured: 3 years
2. To determine whether a Reiki session affects responses to a subsequent acute stressor
Measured: 3 years
Secondary outcomes (3)
Assess which benefits result from placebo and which from unique abilities of Reiki practitioners
Measured: 3 years
Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial
Measured: 3 years
Assess the role of a variety of baseline variables on responses.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2006 (estimated)
- Study startJan 2006
- Primary completionOct 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Joan Fox, The Cleveland Clinic
- Investigators
- Joan E. Fox, PhD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00346671
- Sponsor's protocol ID
- R21AT001884-01
- Status last verified
- Sep 2012
- First submitted
- 29 Jun 2006
- Last updated
- 24 Sep 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Reiki on Physiological Consequences of Acute Stress
- ClinicalTrials.gov ID
- NCT00346671
- Acronym / sponsor ID
- R21AT001884-01
- Conditions
- Stress
- Keywords
- Reiki, Stress, CAM
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Jan 2006
- Primary completion
- Oct 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Jun 2006 (estimated)
- 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.
Complementary therapies such as Reiki are becoming popular. Reiki is a practice used for relaxation and pain management that involves physical touch and social contact with a trained, empathetic practitioner. Unlike many relaxation therapies, Reiki requires no participation by the patient, a feature that makes Reiki particularly attractive in the hospital setting, where patients are often extremely anxious, depressed, in pain, or sedated. Our primary research questions are to determine whether physiological changes are induced during a Reiki session and whether a Reiki session affects responses to a subsequent acute stressor. Secondary research questions include assessing which benefits result from placebo or unique abilities of "attuned" Reiki practitioners and assessing background characteristics of recipients that are associated with acceptance and responsiveness. Based on its use to reduce pain and anxiety, we will study potential mechanisms by which Reiki decreases activity of the sympathetic nervous system and other stress pathways. Comparison of the responses in a Reiki group with those in supine-control and sham groups will allow us to gain insights into mechanisms by which Reiki effects are mediated. Information obtained from the proposed studies will provide detailed information on physiological pathways affected by Reiki. Should Reiki decrease stress pathways or reduce physiological responses to stressful situations, it could be a useful adjunct to traditional medicine and have significant health and economic benefits.
Detailed description
See Brief Summary
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Supine Rest | Placebo comparator | Other: Rest30min supine rest listening to soft music |
| Sham Reiki | Sham comparator | Other: Sham30 min intervention by sham practitioner |
| Reiki | Experimental | Other: Reiki30 min session with Reiki practitioner |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy Individuals between the age of 18 and 75
Key exclusion criteria (12 listed)
- Already involved in regular (one time a week or more) mind-body practices (yoga, meditation, Qi-gong, guided imagery, Taichi, biofeedback; attendance at religious services is not considered a mind-body practice) in the past three months OR has been doing intense spiritual practice for more than 6 months in the past (an average of 6hrs a week)
- Already received an energy therapy treatment (Reiki, therapeutic touch, healing touch, touch therapy) in the past. (note: acupuncture, massage Qi-gong are not considered energy therapies in the context of this study)
- Score on the DASS21 for Depression greater or equal to 21
- Score on the DASS21 for Anxiety greater or equal to 15
- In the last 3 months, has had a major stressful life-event that is likely to affect the outcomes of the study
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 |
|---|---|---|
| Rest30 min supine rest | Other | Supine Rest |
| ShamAlso: Touch, Pretend Reiki, Placebo Reiki30 min session with Sham practitioner | Other | Sham Reiki |
| ReikiAlso: Energy Healing, Energy Therapy, Touch Therapy30 min session with Reiki practitioner | Other | Reiki |
Primary outcome
1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity
Time frame: 3 years
2. To determine whether a Reiki session affects responses to a subsequent acute stressor
Time frame: 3 years
3 secondary outcomes
Assess which benefits result from placebo and which from unique abilities of Reiki practitioners
Time frame: 3 years
Obtain preliminary information on mechanisms needed for the rational design of a larger clinical trial
Time frame: 3 years
Assess the role of a variety of baseline variables on responses.
Time frame: 3 years
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 24 Sep 2012.
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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.
Joan E. Fox, PhD principal investigator
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Rest and Reiki in people with Stress, run by The Cleveland Clinic at 1 site in United States.
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 1 inclusion and 12 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 24 Sep 2012. 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 United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
1: To determine whether a Reiki session affects emotional states, ANS, or HPA activity (time frame: 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Sep 2012.