Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery

Not Applicable

Completed

Conditions: Valvular Heart Diseases
Coronary Artery Diseases

Registration Number: NCT05853250

Lead Sponsor: The Cleveland Clinic

Brief 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 272

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Depression	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	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	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	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	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)	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	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	30 days after discharge	All-cause 30-day hospital readmission rate based on medical record data.
Total Opioid IV Narcotic Burden (Mean) in mg	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	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 Outcome Measures

Name	Time	Method
Number of Participants With Hospital Re-admission Within 30 Days	30 days	Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review.