N/A
N=272
Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
Coronary Artery Diseases · Valvular Heart Diseases
Bottom Line
View on ClinicalTrials.gov: NCT05853250 ↗Enrolled (actual)
272
Serious AEs
—
Results posted
Sep 2025
Primary outcome: Primary: Depression — 0.31; 0.42 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reiki/manual therapy (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Sep 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Depression |
0.29; 0.40 | — |
| PRIMARY Depression |
0.29; 0.40 | — |
| PRIMARY Anxiety |
0.60; 0.78 | — |
| PRIMARY Anxiety |
0.60; 0.78 | — |
| PRIMARY Sleep |
42.7; 46.7 | — |
| PRIMARY Sleep |
42.7; 46.7 | — |
| PRIMARY Pain Level, Mean Score |
2.5; 2.5 | — |
| PRIMARY Pain Level, Median Score |
1.0; 1.5 | — |
| PRIMARY Hospital Length of Stay, Days - Mean (Standard Deviation) |
6.3; 6.5 | — |
| PRIMARY New-onset Postoperative Atrial Fibrillation Complication |
46; 51 | — |
| PRIMARY All-cause 30-day Hospital Readmission |
4; 11 | — |
| PRIMARY Total Opioid IV Narcotic Burden (Mean) in mg |
20; 18.4 | — |
| PRIMARY Total Oral Narcotic Burden (Mean) in Milligarms |
60; 55.3 | — |
| SECONDARY Number of Participants With Hospital Re-admission Within 30 Days |
4; 11 | — |
Summary
Reiki is an energy-based healing therapy using light touch. Manual therapy is a technique using light effleurage. These complimentary healing services are utilized to promote relaxation, sleep, improve emotions, and decrease pain; however, more research is required since sample sizes in the literature were small, subjects were generally healthy (not hospitalized), and subjects had multiple medical backgrounds. Only 1 study focused on cardiac surgery patients. We aim to learn if Reiki and manual therapy enhances postoperative clinical outcomes for patients after first time coronary artery bypass graft (CABG) and/or cardiac valve surgery. A randomized, controlled non-blinded study will enroll a sample of a minimum of 272 patient (136 per group), based on a power analysis using the primary outcome. The intervention group will receive usual care plus Reiki and manual therapy, with Reiki delivered first. Total therapies time is 20 minutes. Reiki and manual therapy will be delivered for 3 consecutive days beginning on the day after endotracheal tube removal. The usual care group will receive 20 minutes of uninterrupted rest, which is part of usual postoperative care. Outcomes are depression, anxiety, pain, night time sleep, new onset atrial fibrillation, hospital length of stay, all-cause 30-day hospital readmissions, narcotic drug burden and post-operative complications.
Eligibility Criteria
Inclusion Criteria
- Over 18 years of age
- Speaks English language and capable of reading and hearing
- Up to 4 "To Come In" patients enrolled per day (2 standard care and 2 intervention group)
- Arrive for surgery from outpatient (home) environment
- Scheduled for surgery (arrives in "To Come In" area) on Monday and Tuesday.
- Lives in one of 6 counties of North East Ohio to ensure access post-discharge hospitalization
Exclusion Criteria
- History of dementia, cognitive decline, Down's syndrome or other neurologic, psychological or congenital deficiency that impacts ability to make decisions about enrollment
- Severe sight and hearing impairment despite assistive devices
- Cardiac surgery on a Wednesday, Thursday or Friday
- Treated in the hospital prior to the day of surgery
- Prolonged intubation (over 48 hours), or reinsertion of an endotracheal tube during or before the intervention is initiated (will result in intervention withdrawal)
- Sedated due to new onset delirium.
Data sourced from ClinicalTrials.gov (NCT05853250). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.