Trial Outcomes & Findings for Clinical and Hospital Stay Effects of Reiki and Manual Therapy After Open Heart Surgery (NCT NCT05853250)

NCT ID: NCT05853250

Last Updated: 2025-09-18

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 272 participants
• Primary outcome timeframe: Pre-operative (baseline)
• Results posted on: 2025-09-18

Participant Flow

From the "to come in" (TCI) list for first time cardiac surgery patients, data collectors retrieved names and interviewed patients that met criteria for the research study. Patients were also enrolled from the Pre-Cath area. Written informed consent was acquired by patients before initiation of the research study. Study recruitment was from 6/26/17 to 9/10/2019.

The patient's surgery was canceled or delayed therefore these people either did not sign the informed consent or they signed the informed consent, but because surgery did not happen on the day scheduled, they did not participate in the study.

Participant milestones

Measure	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. 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.	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.
Overall Study STARTED	136	136
Overall Study COMPLETED	136	136
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.	Total n=272 Participants Total of all reporting groups
Age, Continuous	62.4 years STANDARD_DEVIATION 11.9 • n=5 Participants	62.0 years STANDARD_DEVIATION 12.6 • n=7 Participants	62.2 years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	34 Participants n=5 Participants	33 Participants n=7 Participants	67 Participants n=5 Participants
Sex: Female, Male Male	102 Participants n=5 Participants	103 Participants n=7 Participants	205 Participants n=5 Participants
Race/Ethnicity, Customized White	126 Participants n=5 Participants	124 Participants n=7 Participants	250 Participants n=5 Participants
Race/Ethnicity, Customized Other race/ethnicity	10 Participants n=5 Participants	12 Participants n=7 Participants	22 Participants n=5 Participants
Region of Enrollment United States	136 participants n=5 Participants	136 participants n=7 Participants	272 participants n=5 Participants
Payor Government (Medicare/Medicaid) + Self Pay	35 Participants n=5 Participants	40 Participants n=7 Participants	75 Participants n=5 Participants
Payor Private + Other Inc	101 Participants n=5 Participants	96 Participants n=7 Participants	197 Participants n=5 Participants
Primary Diagnosis Cardiac	95 Participants n=5 Participants	108 Participants n=7 Participants	203 Participants n=5 Participants
Primary Diagnosis Congenital	41 Participants n=5 Participants	28 Participants n=7 Participants	69 Participants n=5 Participants
BMI	28.7 kg/m2 STANDARD_DEVIATION 5.3 • n=5 Participants	27.8 kg/m2 STANDARD_DEVIATION 5.2 • n=7 Participants	28.2 kg/m2 STANDARD_DEVIATION 5.2 • n=5 Participants

PRIMARY outcome

Timeframe: Pre-operative (baseline)

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Depression	0.31 score on a scale Standard Deviation 0.46	0.42 score on a scale Standard Deviation 0.58

PRIMARY outcome

Timeframe: Post-operative (day 3)

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Depression	0.29 mean overall score Standard Deviation 0.41	0.40 mean overall score Standard Deviation 0.50

PRIMARY outcome

Timeframe: Pre-operative (baseline)

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Anxiety	0.81 mean overall score Standard Deviation 0.77	0.94 mean overall score Standard Deviation 0.83

PRIMARY outcome

Timeframe: Post-operative (day 3)

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Anxiety	0.60 mean overall score Standard Deviation 0.60	0.78 mean overall score Standard Deviation 0.86

PRIMARY outcome

Timeframe: Paper surveys distributed pre-operative (baseline)

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Sleep	38.5 score on a scale Standard Deviation 22.2	39.2 score on a scale Standard Deviation 22.4

PRIMARY outcome

Timeframe: 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 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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Sleep	42.7 score on a scale Standard Deviation 26.1	46.7 score on a scale Standard Deviation 25.2

PRIMARY outcome

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

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

Outcome measures

Measure	Reiki/Manual Therapy n=134 Participants 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. 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.	Usual Care Quiet Time n=133 Participants 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.
Pain Level, Mean Score	2.5 median and [Q1, Q3] of the mean score Interval 1.7 to 3.4	2.5 median and [Q1, Q3] of the mean score Interval 1.8 to 3.3

PRIMARY outcome

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

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.

Outcome measures

Measure	Reiki/Manual Therapy n=134 Participants 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. 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.	Usual Care Quiet Time n=133 Participants 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.
Pain Level, Median Score	1.0 score on a scale Interval 0.0 to 3.0	1.5 score on a scale Interval 0.0 to 3.0

PRIMARY outcome

Timeframe: Days of hospital stay

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.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Hospital Length of Stay, Days - Mean (Standard Deviation)	6.3 mean overall days and standard deviation Standard Deviation 2.6	6.5 mean overall days and standard deviation Standard Deviation 2.9

PRIMARY outcome

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

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".

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
New-onset Postoperative Atrial Fibrillation Complication	46 Participants	51 Participants

PRIMARY outcome

Timeframe: 30 days after discharge

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

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
All-cause 30-day Hospital Readmission	4 Participants	11 Participants

PRIMARY outcome

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

Data retrieved via a hospital billing database

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Total Opioid IV Narcotic Burden (Mean) in mg	20 morphine milligram equivalents Interval 10.0 to 31.5	18.4 morphine milligram equivalents Interval 10.0 to 29.2

PRIMARY outcome

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

Data retrieved via a hospital billing database

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Total Oral Narcotic Burden (Mean) in Milligarms	60 morphine milligram equivalents Interval 30.0 to 94.5	55.3 morphine milligram equivalents Interval 30.0 to 87.5

SECONDARY outcome

Timeframe: 30 days

Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review.

Outcome measures

Measure	Reiki/Manual Therapy n=136 Participants 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. 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.	Usual Care Quiet Time n=136 Participants 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.
Number of Participants With Hospital Re-admission Within 30 Days	4 Participants	11 Participants

Adverse Events

Reiki/Manual Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Quiet Time

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Nancy M. Albert, PhD, Associate Chief Nursing Officer

Cleveland Clinic

Phone: 216-444-7028

Email: albertn@ccf.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place