Clinical trial NCT05853250: Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
Official title: Clinical (Sleep, Pain and Atrial Fibrillation) and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Diseases
Valvular Heart Diseases
Keywords: Cardiac surgery
Coronary artery bypass grafting (CABG)
Valve surgery
Reiki
Manual therapy
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 345
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Depression
timeFrame: Paper surveys were distributed pre-operative (baseline)
measure: Depression
timeFrame: Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
measure: Anxiety
timeFrame: Paper surveys were distributed pre-operative (baseline)
measure: Anxiety
timeFrame: Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
measure: Sleep
timeFrame: Paper surveys distributed pre-operative (baseline)
measure: Sleep
timeFrame: Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
measure: Pain level
timeFrame: Mean (SD) value through study completion, an average of 6.4 days
measure: Pain level
timeFrame: Mean (IQR) value through study completion, an average of 6.4 days
measure: Hospital length of stay, days
timeFrame: Through study completion, an average of 6.4 days
measure: New-onset postoperative atrial fibrillation rate (%)
timeFrame: Frequency (%) of new-onset atrial fibrillation complication after open heart surgery
measure: All cause 30-day hospital readmission rate, (%):
timeFrame: 30 days after discharge
measure: Total opioid IV narcotic burden (mean):
timeFrame: Total opioid IV narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
measure: Total oral narcotic burden (mean):
timeFrame: Total oral narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sandra Zampino
role: PRINCIPAL_INVESTIGATOR
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