search
Back to results

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

Primary Purpose

Coronary Artery Diseases, Valvular Heart Diseases

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Reiki/manual therapy
Sponsored by
The Cleveland Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Diseases focused on measuring Cardiac surgery, Coronary artery bypass grafting (CABG), Valve surgery, Reiki, Manual therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Cleveland Clinic Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Reiki/manual therapy

Usual care quiet time

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Depression
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
Depression
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
Anxiety
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
Anxiety
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
Sleep
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.
Sleep
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.
Pain level
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.
Pain level
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.
Hospital length of stay, days
Data retrieved via a hospital billing database.
New-onset postoperative atrial fibrillation rate (%)
Data retrieved from the Society of Thoracic Surgeons Registry
All cause 30-day hospital readmission rate, (%):
Data retrieved via a hospital billing database
Total opioid IV narcotic burden (mean):
Data retrieved via a hospital billing database
Total oral narcotic burden (mean):
Data retrieved via a hospital billing database

Secondary Outcome Measures

Full Information

First Posted
April 11, 2023
Last Updated
May 8, 2023
Sponsor
The Cleveland Clinic
search

1. Study Identification

Unique Protocol Identification Number
NCT05853250
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 26, 2017 (Actual)
Primary Completion Date
September 18, 2019 (Actual)
Study Completion Date
February 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Cleveland Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Diseases, Valvular Heart Diseases
Keywords
Cardiac surgery, Coronary artery bypass grafting (CABG), Valve surgery, Reiki, Manual therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Care ProviderOutcomes Assessor
Masking Description
Personnel who recruited and enrolled patients preoperatively were not involved in any other component of the study. Surgeons and medical providers did not receive any information about group assignment. Reiki/manual therapy personnel did not collect outcome "survey" data; those that did were not informed of group assignment. Data coming from a database was retrieved by a data analyst who did not receive group assignment information.
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Reiki/manual therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care quiet time
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Reiki/manual therapy
Intervention Description
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 Outcome Measure Information:
Title
Depression
Description
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
Time Frame
Paper surveys were distributed pre-operative (baseline)
Title
Depression
Description
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
Time Frame
Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Title
Anxiety
Description
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
Time Frame
Paper surveys were distributed pre-operative (baseline)
Title
Anxiety
Description
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
Time Frame
Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Title
Sleep
Description
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.
Time Frame
Paper surveys distributed pre-operative (baseline)
Title
Sleep
Description
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.
Time Frame
Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
Title
Pain level
Description
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.
Time Frame
Mean (SD) value through study completion, an average of 6.4 days
Title
Pain level
Description
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.
Time Frame
Mean (IQR) value through study completion, an average of 6.4 days
Title
Hospital length of stay, days
Description
Data retrieved via a hospital billing database.
Time Frame
Through study completion, an average of 6.4 days
Title
New-onset postoperative atrial fibrillation rate (%)
Description
Data retrieved from the Society of Thoracic Surgeons Registry
Time Frame
Frequency (%) of new-onset atrial fibrillation complication after open heart surgery
Title
All cause 30-day hospital readmission rate, (%):
Description
Data retrieved via a hospital billing database
Time Frame
30 days after discharge
Title
Total opioid IV narcotic burden (mean):
Description
Data retrieved via a hospital billing database
Time Frame
Total opioid IV narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days
Title
Total oral narcotic burden (mean):
Description
Data retrieved via a hospital billing database
Time Frame
Total oral narcotic medication dose, using morphine equivalent data, during the length of stay, an average 6.4 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sandra Zampino
Organizational Affiliation
The Cleveland Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
19944872
Citation
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.
Results Reference
background
PubMed Identifier
17495551
Citation
Anderson 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.
Results Reference
background
PubMed Identifier
26025795
Citation
Boitor 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.
Results Reference
background
PubMed Identifier
17998077
Citation
Borm 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.
Results Reference
background
PubMed Identifier
22964355
Citation
Braun 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.
Results Reference
background
PubMed Identifier
20347840
Citation
Cutshall 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.
Results Reference
background
PubMed Identifier
19493579
Citation
Doering 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.
Results Reference
background
PubMed Identifier
20400379
Citation
Gordon 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.
Results Reference
background
PubMed Identifier
18410352
Citation
Lee 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.
Results Reference
background
PubMed Identifier
18616066
Citation
MacIntyre 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.
Results Reference
background
PubMed Identifier
15674004
Citation
Mackay 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.
Results Reference
background
Citation
Rand W. (1991). The Healing Touch. First and Second Degree Manual. Vision Publication: Southfield, MI.
Results Reference
background
PubMed Identifier
11227580
Citation
Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44.
Results Reference
background
Citation
Society 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.
Results Reference
background
PubMed Identifier
19922247
Citation
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.
Results Reference
background
PubMed Identifier
17627194
Citation
Vitale A. An integrative review of Reiki touch therapy research. Holist Nurs Pract. 2007 Jul-Aug;21(4):167-79; quiz 180-1. doi: 10.1097/01.HNP.0000280927.83506.f6.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs