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

Coronary Artery Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05853250
• Other study ID #: 17-184
• Status: Completed
• Phase: N/A
• Start date: June 26, 2017
• Est. completion date: February 5, 2020

Study information

• Verified date: May 2023
• Source: The Cleveland Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 345
• Est. completion date: February 5, 2020
• Est. primary completion date: September 18, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Heart Diseases
• Heart Valve Diseases

Intervention

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.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

References & Publications (16)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Rand W. (1991). The Healing Touch. First and Second Degree Manual. Vision Publication: Southfield, MI.

Richards KC, O'Sullivan PS, Phillips RL. Measurement of sleep in critically ill patients. J Nurs Meas. 2000 Fall-Winter;8(2):131-44. — View 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.

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. — View 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. — View Citation

* Note: There are 16 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Paper surveys were distributed pre-operative (baseline)
Primary	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	Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Primary	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	Paper surveys were distributed pre-operative (baseline)
Primary	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	Paper surveys distributed post-operative (day 3) after the final reiki and manual therapies intervention or quiet time sessions were completed.
Primary	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.	Paper surveys distributed pre-operative (baseline)
Primary	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.	Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
Primary	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.	Mean (SD) value through study completion, an average of 6.4 days
Primary	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.	Mean (IQR) value through study completion, an average of 6.4 days
Primary	Hospital length of stay, days	Data retrieved via a hospital billing database.	Through study completion, an average of 6.4 days
Primary	New-onset postoperative atrial fibrillation rate (%)	Data retrieved from the Society of Thoracic Surgeons Registry	Frequency (%) of new-onset atrial fibrillation complication after open heart surgery
Primary	All cause 30-day hospital readmission rate, (%):	Data retrieved via a hospital billing database	30 days after discharge
Primary	Total opioid IV narcotic burden (mean):	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
Primary	Total oral narcotic burden (mean):	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