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

May 8, 2023 updated by: Nancy M. Albert, Ph.D., The Cleveland Clinic

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

345

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Reiki/manual therapy
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.
Other: Reiki/manual therapy
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.
No Intervention: Usual care quiet time
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression
Time Frame: Paper surveys were distributed pre-operative (baseline)
The Brief Symptom Inventory; 12-item survey, provides severity indexes for depression and anxiety Valid and reliable; 5-level Likert-type response set, ranging from 0, not at all to 4, extremely
Paper surveys were distributed pre-operative (baseline)
Depression
Time Frame: Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
The Brief Symptom Inventory; 12-item survey, provides severity indexes for depression and anxiety Valid and reliable; 5-level Likert-type response set, ranging from 0, not at all to 4, extremely
Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Anxiety
Time Frame: Paper surveys were distributed pre-operative (baseline)
The Brief Symptom Inventory; 12-item survey, provides severity indexes for depression and anxiety Valid and reliable; 5-level Likert-type response set, ranging from 0, not at all to 4, extremely
Paper surveys were distributed pre-operative (baseline)
Anxiety
Time Frame: Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
The Brief Symptom Inventory; 12-item survey, provides severity indexes for depression and anxiety Valid and reliable; 5-level Likert-type response set, ranging from 0, not at all to 4, extremely
Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Sleep
Time Frame: Paper surveys distributed pre-operative (baseline)
The Richards-Campbell Sleep Questionnaire (RCSQ) Valid and Reliable; has 5 item survey as 5 domains: sleep depth, falling asleep, number of 5 items awakenings, percent of time awake, and overall quality of sleep.
Paper surveys distributed pre-operative (baseline)
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; has 5 item survey as 5 domains: sleep depth, falling asleep, number of 5 items awakenings, percent of time awake, and overall quality of sleep.
Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
Pain level
Time Frame: Mean (SD) value through study completion, an average of 6.4 days

Pain intensity was assessed on a scale of 0-10 (higher score = worst pain)

• Highest (worst), lowest (least), mean and median pain scores were assessed.
Mean (SD) value through study completion, an average of 6.4 days
Pain level
Time Frame: Mean (IQR) value through study completion, an average of 6.4 days

Pain intensity was assessed on a scale of 0-10 (higher score = worst pain)

• Highest (worst), lowest (least), mean and median pain scores were assessed.
Mean (IQR) value through study completion, an average of 6.4 days
Hospital length of stay, days
Time Frame: Through study completion, an average of 6.4 days
Data retrieved via a hospital billing database.
Through study completion, an average of 6.4 days
New-onset postoperative atrial fibrillation rate (%)
Time Frame: Frequency (%) of new-onset atrial fibrillation complication after open heart surgery
Data retrieved from the Society of Thoracic Surgeons Registry
Frequency (%) of new-onset atrial fibrillation complication after open heart surgery
All cause 30-day hospital readmission rate, (%):
Time Frame: 30 days after discharge
Data retrieved via a hospital billing database
30 days after discharge
Total opioid IV narcotic burden (mean):
Time Frame: Total opioid IV narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
Data retrieved via a hospital billing database
Total opioid IV narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
Total oral narcotic burden (mean):
Time Frame: Total oral narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
Data retrieved via a hospital billing database
Total oral narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Sandra Zampino, The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2017

Primary Completion (Actual)

September 18, 2019

Study Completion (Actual)

February 5, 2020

Study Registration Dates

First Submitted

April 11, 2023

First Submitted That Met QC Criteria

May 8, 2023

First Posted (Actual)

May 10, 2023

Study Record Updates

Last Update Posted (Actual)

May 10, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-184

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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