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

NCT05853250 | Completed Results

• 1 other identifier: 17-184
• Study Type: interventional
• Target: 272
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Diseases; Valvular Heart Diseases

Keywords

Cardiac surgery; Coronary artery bypass grafting (CABG); Valve surgery; Reiki; Manual therapy

Outcome Measures

Primary Outcomes (13)

• Depression

  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.

  Pre-operative (baseline)

• Depression

  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.

  Post-operative (day 3)

• Anxiety

  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.

  Pre-operative (baseline)

• Anxiety

  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.

  Post-operative (day 3)

• Sleep

  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.

  Paper surveys distributed pre-operative (baseline)

• Sleep

  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.

  Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.

• Pain Level, Mean Score

  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

  Post-operative thru day 3 after the 1st intervention/usual care was administered

• Pain Level, Median Score

  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.

  Post-operative thru day 3 after the 1st intervention/usual care was administered

• Hospital Length of Stay, Days - Mean (Standard Deviation)

  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.

  Days of hospital stay

• New-onset Postoperative Atrial Fibrillation Complication

  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".

  Post-operation (from day of surgery until hospital discharge)

• All-cause 30-day Hospital Readmission

  All-cause 30-day hospital readmission rate based on medical record data.

  30 days after discharge

• Total Opioid IV Narcotic Burden (Mean) in mg

  Data retrieved via a hospital billing database

  Total opioid IV narcotic medication dose (in milligrams), using morphine equivalent data, during the length of stay, an average 6.4 days

• Total Oral Narcotic Burden (Mean) in Milligarms

  Data retrieved via a hospital billing database

  Total oral narcotic medication dose in milligrams, using morphine equivalent data, during the length of stay, an average 6.4 days

Secondary Outcomes (1)

• Number of Participants With Hospital Re-admission Within 30 Days

  30 days

Study Arms (2)

Reiki/manual therapy

EXPERIMENTAL

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

Usual care quiet time

NO INTERVENTION

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.

Interventions

Reiki/manual therapy OTHER

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.

Reiki/manual therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Cleveland Clinic: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Related 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.

  PMID: 19944872 BACKGROUND

• 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.

  PMID: 17495551 BACKGROUND

• 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.

  PMID: 26025795 BACKGROUND

• 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.

  PMID: 17998077 BACKGROUND

• 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.

  PMID: 22964355 BACKGROUND

• 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.

  PMID: 20347840 BACKGROUND

• 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.

  PMID: 19493579 BACKGROUND

• 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.

  PMID: 20400379 BACKGROUND

• 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.

  PMID: 18410352 BACKGROUND

• 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.

  PMID: 18616066 BACKGROUND

• 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.

  PMID: 15674004 BACKGROUND

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

  BACKGROUND

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

  PMID: 11227580 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 19922247 BACKGROUND

• 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.

  PMID: 17627194 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease; Heart Valve Diseases

Interventions

Therapeutic Touch; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Physical Therapy Modalities; Rehabilitation

Results Point of Contact

• Title: Nancy M. Albert, PhD, Associate Chief Nursing Officer
• Organization: Cleveland Clinic

albertn@ccf.org

216-444-7028

Study Officials

• Sandra Zampino

  The Cleveland Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Nursing Officer, Office of Nursing Research, Principal Investigator of record (Sandy Zampino left Cleveland Clinic)

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: May 10, 2023
• Study Start: June 26, 2017
• Primary Completion: September 18, 2019
• Study Completion: February 5, 2020
• Last Updated: September 18, 2025
• Results First Posted: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)