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OpenTrials
Completed

NCT Number: NCT05853250

Clinical 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.

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Key information

Conditions

Coronary Artery Diseases Arterial Occlusive Diseases Arteriosclerosis Cardiovascular Diseases Coronary Artery Disease Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Valvular Heart Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Reiki/manual therapy

Other

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. 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.

  9. 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.

  10. 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".

  11. All-cause 30-day Hospital Readmission

    Time frame: 30 days after discharge

    All-cause 30-day hospital readmission rate based on medical record data.

  12. 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

  13. 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

Secondary outcomes

  1. Number of Participants With Hospital Re-admission Within 30 Days

    Time frame: 30 days

    Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review.

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

Clinical (Sleep, Pain and Atrial Fibrillation) and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
May 10, 2023
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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