Coronary Artery DiseasesNCT05853250
Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
A study testing Reiki/manual therapy in people with Coronary Artery Diseases and Valvular Heart Diseases, run by The Cleveland Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Artery Diseases, Valvular Heart Diseases
- What is being tested?
- Reiki/manual therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to 5 Feb 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical (Sleep, Pain and Atrial Fibrillation) and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
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.
Read the detailed description
Background: 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. After reviewing the Reiki research literature, more research is required since sample sizes were small, subjects were generally healthy (not hospitalized), and subjects had multiple medical backgrounds. Only 1 study focused on cardiac surgery patients. In the current research study, 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.
Design and Methods: A randomized, controlled non-blinded study will be used. The sample size (272 total; 136 per group) was based on a power analysis using the primary outcome. The intervention group will receive usual care plus Reiki and manual therapy, with Reiki being delivered first. Hand placements include: head, chest, shoulders, hands, knees, and feet for 15 minutes. Manual therapy will consist of light effleurage to the head and feet for 5 minutes. 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. There will not be a sham-treatment group, based on previous research findings.
Outcome Measures: depression and anxiety (Brief Symptom Inventory, 12-item self-administered tool); pain (self-reported and recorded in electronic health record by staff nurses as part of usual care -- 0 [no pain] - 10 [worst pain] scale), highest (worst) and lowest (least) pain in the past 24 hours will be assessed; night time sleep (Richards-Campbell Sleep Questionnaire; 5 item self-administered tool)-to be measured at baseline and after the last Reiki/manual therapy treatment or 3 days of usual care; hospital length of stay, all-cause 30-day hospital readmissions (data top be retrieved from a billing database), narcotic drug burden (mean dose) use on postoperative days 3 and 4 (retrieved from electronic medical records), patient characteristics, medical history, surgical procedure, new onset atrial fibrillation and other post-operative complications (retrieved from the Institutional Review Board--approved Cardiothoracic Surgery database).
- Conditions
- Coronary Artery Diseases, Valvular Heart Diseases
- Being tested
- Reiki/manual therapy
- Keywords
- Cardiac surgery, Coronary artery bypass grafting (CABG), Valve surgery, Reiki, Manual therapy
- Medical subject headings
- Coronary Artery Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reiki/manual therapyOther
Reiki is delivered by gentle hand placement either on or slightly above the body by certified Reiki practitioners. In this study, Reiki will be delivered first, for 15 minutes and will involve light placement of hands on patients' head, chest, shoulders, hands, knees, and feet (~ 3 minutes to each body part). Manual therapy techniques include light effleurage to head and feet (for 5 minutes; ~ 2.5 minutes to each body part) by the Reiki practitioner who delivered the Reiki therapy.
| Study group | Role | What they receive |
|---|---|---|
| Reiki/manual therapy | Experimental | Reiki, a Japanese energy-based healing technique, is universal vital energy that flows throughout and encompasses all living forms (Rand, 1991). It is delivered by gentle hand placement either on/slightly above the body by certified Reiki practitioners. In this study, Reiki will be delivered first, for 15 min. and will involve light placement of hands on patients' head, chest, shoulders, hands, knees, and feet (~ 3 minutes to each body part). Manual therapy (MT) includes light effleurage to head and feet (for 5 minutes; ~ 2.5 minutes to each body part) by the Reiki practitioner. MT techniques are defined as light circular stroking movements made with the hands. Reiki and MT will be delivered for 3 consecutive days beginning on the day after endotracheal tube removal. Reiki and MT will be delivered by 4 Reiki practitioners with training at a Level 2+. Reiki and manual therapy was delivered as one intervention. They are not two separate interventions. Receives: Other: Reiki/manual therapy |
| Usual care quiet time | No intervention | All usual care provided pre and post-operative management will continue, uninterrupted; including the 20 minute rest period. The only non-usual care component will be placement of a sign on the door to discourage visitors and providers from entering the room and disturbing the rest period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression
The Brief Symptom Inventory has a depression dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the depression; score range is 0-24.
Measured: Pre-operative (baseline)
Depression
The Brief Symptom Inventory has a depression dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the depression; score range is 0-24.
Measured: Post-operative (day 3)
Anxiety
The Brief Symptom Inventory has a anxiety dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the anxiety; score range is 0-24.
Measured: Pre-operative (baseline)
Anxiety
The Brief Symptom Inventory has a anxiety dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the anxiety; score range is 0-24.
Measured: Post-operative (day 3)
Sleep
The Richards-Campbell Sleep Questionnaire (RCSQ) Valid and Reliable survey with 5 domains (sleep depth, sleep latency, awakenings from sleep, ability to return to sleep, and sleep quality) and 1 question for each domain, therefore the tool has a total of 5 items.
The visual analog scale uses statements on either side of a 0 to 100 mm horizontal line. For example, deep sleep ____ light sleep. Participants place a vertical line on the horizontal 100mm scale, to reflect which item on the scale best matches the response to each question. A ruler is used to record the mm marking of each item. A sleep score is created by dividing the sum of the length in mm of visual analog lines by 5.
Higher scores indicates greater sleep disturbances.
Measured: Paper surveys distributed pre-operative (baseline)
Sleep
The Richards-Campbell Sleep Questionnaire (RCSQ) Valid and Reliable survey with 5 domains (sleep depth, sleep latency, awakenings from sleep, ability to return to sleep, and sleep quality) and 1 question for each domain, therefore the tool has a total of 5 items.
The visual analog scale uses statements on either side of a 0 to 100 mm horizontal line. For example, deep sleep ____ light sleep. Participants place a vertical line on the horizontal 100mm scale, to reflect which item on the scale best matches the response to each question. A ruler is used to record the mm marking of each item. A sleep score is created by dividing the sum of the length in mm of visual analog lines by 5.
Higher scores indicates greater sleep disturbances.
Measured: Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
Pain Level, Mean Score
Pain intensity was assessed on a numerical scale of 0-10 by nurses as part of usual care documentation which was generally completed every 4 hours (higher score = worst pain). Mean scores are presented as median with (P25, P75) by group
Measured: Post-operative thru day 3 after the 1st intervention/usual care was administered
Pain Level, Median Score
Pain intensity was assessed on a numerical scale of 0-10 by nurses as part of usual care documentation which was generally completed every 4 hours (higher score = worst pain). Data represent median (P25, P75) score values by group.
Measured: Post-operative thru day 3 after the 1st intervention/usual care was administered
Hospital Length of Stay, Days - Mean (Standard Deviation)
Length of stay equals date of surgery (day 0) to date before the day of hospital discharge (we do NOT include the day of discharge). The number is continuous and is based on the actual length of the POSTOPERATIVE hospital stay and is based on being in the hospital at 12 MN. There is no pre-specified maximum number.
Measured: Days of hospital stay
New-onset Postoperative Atrial Fibrillation Complication
Dichotomous variable (Yes versus No) based on medical record documentation of new-onset postoperative atrial fibrillation anytime in the postoperative period. The total number of "yes" responses were compared between groups as a "count".
Measured: Post-operation (from day of surgery until hospital discharge)
All-cause 30-day Hospital Readmission
All-cause 30-day hospital readmission rate based on medical record data.
Measured: 30 days after discharge
Total Opioid IV Narcotic Burden (Mean) in mg
Data retrieved via a hospital billing database
Measured: Total opioid IV narcotic medication dose (in milligrams), using morphine equivalent data, during the length of stay, an average 6.4 days
Total Oral Narcotic Burden (Mean) in Milligarms
Data retrieved via a hospital billing database
Measured: Total oral narcotic medication dose in milligrams, using morphine equivalent data, during the length of stay, an average 6.4 days
Secondary outcomes (1)
Number of Participants With Hospital Re-admission Within 30 Days
Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start26 Jun 2017
- Primary completion18 Sep 2019
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseasesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients were recruited and enrolled into the study preoperatively. After completing baseline information, they were randomized to the intervention or control group. After surgery they received the group assignment.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nancy M. Albert, Ph.D., The Cleveland Clinic
- Investigators
- Sandra Zampino, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853250
- Sponsor's protocol ID
- 17-184
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2023
- Last updated
- 18 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Albert NM, Gillinov AM, Lytle BW, Feng J, Cwynar R, Blackstone EH. A randomized trial of massage therapy after heart surgery. Heart Lung. 2009 Nov-Dec;38(6):480-90. doi: 10.1016/j.hrtlng.2009.03.001. Epub 2009 Jun 28.
PubMed 19944872Anderson PG, Cutshall SM. Massage therapy: a comfort intervention for cardiac surgery patients. Clin Nurse Spec. 2007 May-Jun;21(3):161-5; quiz 166-7. doi: 10.1097/01.NUR.0000270014.97457.d5.
PubMed 17495551Boitor M, Martorella G, Arbour C, Michaud C, Gelinas C. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial. Pain Manag Nurs. 2015 Jun;16(3):354-66. doi: 10.1016/j.pmn.2014.08.014.
PubMed 26025795Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.
PubMed 17998077Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
PubMed 22964355Cutshall SM, Wentworth LJ, Engen D, Sundt TM, Kelly RF, Bauer BA. Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study. Complement Ther Clin Pract. 2010 May;16(2):92-5. doi: 10.1016/j.ctcp.2009.10.006. Epub 2009 Nov 14.
PubMed 20347840Doering LV, Moser DK, Riegel B, McKinley S, Davidson P, Baker H, Meischke H, Dracup K. Persistent comorbid symptoms of depression and anxiety predict mortality in heart disease. Int J Cardiol. 2010 Nov 19;145(2):188-192. doi: 10.1016/j.ijcard.2009.05.025. Epub 2009 Jun 2.
PubMed 19493579Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
PubMed 20400379Lee MS, Pittler MH, Ernst E. Effects of reiki in clinical practice: a systematic review of randomised clinical trials. Int J Clin Pract. 2008 Jun;62(6):947-54. doi: 10.1111/j.1742-1241.2008.01729.x. Epub 2008 Apr 10.
PubMed 18410352MacIntyre B, Hamilton J, Fricke T, Ma W, Mehle S, Michel M. The efficacy of healing touch in coronary artery bypass surgery recovery: a randomized clinical trial. Altern Ther Health Med. 2008 Jul-Aug;14(4):24-32.
PubMed 18616066Mackay N, Hansen S, McFarlane O. Autonomic nervous system changes during Reiki treatment: a preliminary study. J Altern Complement Med. 2004 Dec;10(6):1077-81. doi: 10.1089/acm.2004.10.1077.
PubMed 15674004Rand W. (1991). The Healing Touch. First and Second Degree Manual. Vision Publication: Southfield, MI.
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
PubMed 11227580Society of Thoracic Surgeons. The Society of Thoracic Surgeons Adult Cardiac Surgery Database data collection form version 2.81, April 23,2015. Society of Thoracic Surgeons, www.sts.org. Accessed 09-12-2016.
vanderVaart S, Gijsen VM, de Wildt SN, Koren G. A systematic review of the therapeutic effects of Reiki. J Altern Complement Med. 2009 Nov;15(11):1157-69. doi: 10.1089/acm.2009.0036.
PubMed 19922247
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical (Sleep, Pain and Atrial Fibrillation) and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
- ClinicalTrials.gov ID
- NCT05853250
- Acronym / sponsor ID
- 17-184
- Conditions
- Coronary Artery Diseases, Valvular Heart Diseases
- Keywords
- Cardiac surgery, Coronary artery bypass grafting (CABG), Valve surgery, Reiki, Manual therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- 18 Sep 2019 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 10 May 2023 (actual)
- Results
- Posted 18 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: 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. After reviewing the Reiki research literature, more research is required since sample sizes were small, subjects were generally healthy (not hospitalized), and subjects had multiple medical backgrounds. Only 1 study focused on cardiac surgery patients. In the current research study, 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.
Design and Methods: A randomized, controlled non-blinded study will be used. The sample size (272 total; 136 per group) was based on a power analysis using the primary outcome. The intervention group will receive usual care plus Reiki and manual therapy, with Reiki being delivered first. Hand placements include: head, chest, shoulders, hands, knees, and feet for 15 minutes. Manual therapy will consist of light effleurage to the head and feet for 5 minutes. 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. There will not be a sham-treatment group, based on previous research findings.
Outcome Measures: depression and anxiety (Brief Symptom Inventory, 12-item self-administered tool); pain (self-reported and recorded in electronic health record by staff nurses as part of usual care -- 0 [no pain] - 10 [worst pain] scale), highest (worst) and lowest (least) pain in the past 24 hours will be assessed; night time sleep (Richards-Campbell Sleep Questionnaire; 5 item self-administered tool)-to be measured at baseline and after the last Reiki/manual therapy treatment or 3 days of usual care; hospital length of stay, all-cause 30-day hospital readmissions (data top be retrieved from a billing database), narcotic drug burden (mean dose) use on postoperative days 3 and 4 (retrieved from electronic medical records), patient characteristics, medical history, surgical procedure, new onset atrial fibrillation and other post-operative complications (retrieved from the Institutional Review Board--approved Cardiothoracic Surgery database).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were recruited and enrolled into the study preoperatively. After completing baseline information, they were randomized to the intervention or control group. After surgery they received the group assignment.
| Arm | Type | Receives |
|---|---|---|
| Reiki/manual therapy | Experimental | Other: Reiki/manual therapyReiki, a Japanese energy-based healing technique, is universal vital energy that flows throughout and encompasses all living forms (Rand, 1991). It is delivered by gentle hand placement either on/slightly above the body by certified Reiki practitioners. In this study, Reiki will be delivered first, for 15 min. and will involve light placement of hands on patients' head, chest, shoulders, hands, knees, and feet (~ 3 minutes to each body part). Manual therapy (MT) includes light effleurage to head and feet (for 5 minutes; ~ 2.5 minutes to each body part) by the Reiki practitioner. MT techniques are defined as light circular stroking movements made with the hands. Reiki and MT will be delivered for 3 consecutive days beginning on the day after endotracheal tube removal. Reiki and MT will be delivered by 4 Reiki practitioners with training at a Level 2+. Reiki and manual therapy was delivered as one intervention. They are not two separate interventions. |
| Usual care quiet time | No intervention | –All usual care provided pre and post-operative management will continue, uninterrupted; including the 20 minute rest period. The only non-usual care component will be placement of a sign on the door to discourage visitors and providers from entering the room and disturbing the rest period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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)
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 |
|---|---|---|
| Reiki/manual therapyReiki is delivered by gentle hand placement either on or slightly above the body by certified Reiki practitioners. In this study, Reiki will be delivered first, for 15 minutes and will involve light placement of hands on patients' head, chest, shoulders, hands, knees, and feet (~ 3 minutes to each body part). Manual therapy techniques include light effleurage to head and feet (for 5 minutes; ~ 2.5 minutes to each body part) by the Reiki practitioner who delivered the Reiki therapy. | Other | Reiki/manual therapy |
Primary outcome
Depression
Time frame: Pre-operative (baseline)
The Brief Symptom Inventory has a depression dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the depression; score range is 0-24.
Depression
Time frame: Post-operative (day 3)
The Brief Symptom Inventory has a depression dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the depression; score range is 0-24.
Anxiety
Time frame: Pre-operative (baseline)
The Brief Symptom Inventory has a anxiety dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the anxiety; score range is 0-24.
Anxiety
Time frame: Post-operative (day 3)
The Brief Symptom Inventory has a anxiety dimension that includes 6 items. Participants are asked to consider the "past week" when responding and each item is scored on a 5-point scale, from 0 (not at all) to 4 (extremely). The higher the score, the worse the anxiety; score range is 0-24.
Sleep
Time frame: Paper surveys distributed pre-operative (baseline)
The Richards-Campbell Sleep Questionnaire (RCSQ) Valid and Reliable survey with 5 domains (sleep depth, sleep latency, awakenings from sleep, ability to return to sleep, and sleep quality) and 1 question for each domain, therefore the tool has a total of 5 items. The visual analog scale uses statements on either side of a 0 to 100 mm horizontal line. For example, deep sleep ____ light sleep. Participants place a vertical line on the horizontal 100mm scale, to reflect which item on the scale best matches the response to each question. A ruler is used to record the mm marking of each item. A sleep score is created by dividing the sum of the length in mm of visual analog lines by 5. Higher scores indicates greater sleep disturbances.
Sleep
Time frame: Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
The Richards-Campbell Sleep Questionnaire (RCSQ) Valid and Reliable survey with 5 domains (sleep depth, sleep latency, awakenings from sleep, ability to return to sleep, and sleep quality) and 1 question for each domain, therefore the tool has a total of 5 items. The visual analog scale uses statements on either side of a 0 to 100 mm horizontal line. For example, deep sleep ____ light sleep. Participants place a vertical line on the horizontal 100mm scale, to reflect which item on the scale best matches the response to each question. A ruler is used to record the mm marking of each item. A sleep score is created by dividing the sum of the length in mm of visual analog lines by 5. Higher scores indicates greater sleep disturbances.
Pain Level, Mean Score
Time frame: Post-operative thru day 3 after the 1st intervention/usual care was administered
Pain intensity was assessed on a numerical scale of 0-10 by nurses as part of usual care documentation which was generally completed every 4 hours (higher score = worst pain). Mean scores are presented as median with (P25, P75) by group
Pain Level, Median Score
Time frame: Post-operative thru day 3 after the 1st intervention/usual care was administered
Pain intensity was assessed on a numerical scale of 0-10 by nurses as part of usual care documentation which was generally completed every 4 hours (higher score = worst pain). Data represent median (P25, P75) score values by group.
Hospital Length of Stay, Days - Mean (Standard Deviation)
Time frame: Days of hospital stay
Length of stay equals date of surgery (day 0) to date before the day of hospital discharge (we do NOT include the day of discharge). The number is continuous and is based on the actual length of the POSTOPERATIVE hospital stay and is based on being in the hospital at 12 MN. There is no pre-specified maximum number.
New-onset Postoperative Atrial Fibrillation Complication
Time frame: Post-operation (from day of surgery until hospital discharge)
Dichotomous variable (Yes versus No) based on medical record documentation of new-onset postoperative atrial fibrillation anytime in the postoperative period. The total number of "yes" responses were compared between groups as a "count".
All-cause 30-day Hospital Readmission
Time frame: 30 days after discharge
All-cause 30-day hospital readmission rate based on medical record data.
Total Opioid IV Narcotic Burden (Mean) in mg
Time frame: Total opioid IV narcotic medication dose (in milligrams), using morphine equivalent data, during the length of stay, an average 6.4 days
Data retrieved via a hospital billing database
Total Oral Narcotic Burden (Mean) in Milligarms
Time frame: Total oral narcotic medication dose in milligrams, using morphine equivalent data, during the length of stay, an average 6.4 days
Data retrieved via a hospital billing database
1 secondary outcome
Number of Participants With Hospital Re-admission Within 30 Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19944872Albert NM, Gillinov AM, Lytle BW, Feng J, Cwynar R, Blackstone EH. A randomized trial of massage therapy after heart surgery. Heart Lung. 2009 Nov-Dec;38(6):480-90. doi: 10.1016/j.hrtlng.2009.03.001. Epub 2009 Jun 28.
- Background: PubMed 17495551Anderson PG, Cutshall SM. Massage therapy: a comfort intervention for cardiac surgery patients. Clin Nurse Spec. 2007 May-Jun;21(3):161-5; quiz 166-7. doi: 10.1097/01.NUR.0000270014.97457.d5.
- Background: PubMed 26025795Boitor M, Martorella G, Arbour C, Michaud C, Gelinas C. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial. Pain Manag Nurs. 2015 Jun;16(3):354-66. doi: 10.1016/j.pmn.2014.08.014.
- Background: PubMed 17998077Borm GF, Fransen J, Lemmens WA. A simple sample size formula for analysis of covariance in randomized clinical trials. J Clin Epidemiol. 2007 Dec;60(12):1234-8. doi: 10.1016/j.jclinepi.2007.02.006. Epub 2007 Jun 6.
- Background: PubMed 22964355Braun LA, Stanguts C, Casanelia L, Spitzer O, Paul E, Vardaxis NJ, Rosenfeldt F. Massage therapy for cardiac surgery patients--a randomized trial. J Thorac Cardiovasc Surg. 2012 Dec;144(6):1453-9, 1459.e1. doi: 10.1016/j.jtcvs.2012.04.027. Epub 2012 Sep 7.
- Background: PubMed 20347840Cutshall SM, Wentworth LJ, Engen D, Sundt TM, Kelly RF, Bauer BA. Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study. Complement Ther Clin Pract. 2010 May;16(2):92-5. doi: 10.1016/j.ctcp.2009.10.006. Epub 2009 Nov 14.
- Background: PubMed 19493579Doering LV, Moser DK, Riegel B, McKinley S, Davidson P, Baker H, Meischke H, Dracup K. Persistent comorbid symptoms of depression and anxiety predict mortality in heart disease. Int J Cardiol. 2010 Nov 19;145(2):188-192. doi: 10.1016/j.ijcard.2009.05.025. Epub 2009 Jun 2.
- Background: PubMed 20400379Gordon DB, Polomano RC, Pellino TA, Turk DC, McCracken LM, Sherwood G, Paice JA, Wallace MS, Strassels SA, Farrar JT. Revised American Pain Society Patient Outcome Questionnaire (APS-POQ-R) for quality improvement of pain management in hospitalized adults: preliminary psychometric evaluation. J Pain. 2010 Nov;11(11):1172-86. doi: 10.1016/j.jpain.2010.02.012. Epub 2010 Apr 18.
- Background: PubMed 18410352Lee MS, Pittler MH, Ernst E. Effects of reiki in clinical practice: a systematic review of randomised clinical trials. Int J Clin Pract. 2008 Jun;62(6):947-54. doi: 10.1111/j.1742-1241.2008.01729.x. Epub 2008 Apr 10.
- Background: PubMed 18616066MacIntyre B, Hamilton J, Fricke T, Ma W, Mehle S, Michel M. The efficacy of healing touch in coronary artery bypass surgery recovery: a randomized clinical trial. Altern Ther Health Med. 2008 Jul-Aug;14(4):24-32.
- Background: PubMed 15674004Mackay N, Hansen S, McFarlane O. Autonomic nervous system changes during Reiki treatment: a preliminary study. J Altern Complement Med. 2004 Dec;10(6):1077-81. doi: 10.1089/acm.2004.10.1077.
- BackgroundRand W. (1991). The Healing Touch. First and Second Degree Manual. Vision Publication: Southfield, MI.
- Individual participant dataSharing planned: No
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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.
Sandra Zampino 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 study testing Reiki/manual therapy in people with Coronary Artery Diseases and Valvular Heart Diseases, 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 6 inclusion and 6 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 18 Sep 2025. 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. 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?
Yes. Results are posted in the registry (first posted 18 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Depression (time frame: Pre-operative (baseline)). The study lists 13 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 NCT05853250, which also lists 16 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 18 Sep 2025.