Coronary Artery Diseases, Valvular Heart Diseases
Conditions
Keywords
Cardiac surgery, Coronary artery bypass grafting (CABG), Valve surgery, Reiki, Manual therapy
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).
Interventions
OTHERReiki/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.
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Outcomes 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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Oral Narcotic Burden (Mean) in Milligarms | 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 |
| Depression | 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. |
| Anxiety | 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. |
| Sleep | 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. |
| Pain Level, Mean Score | 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 |
| Pain Level, Median Score | 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. |
| Hospital Length of Stay, Days - Mean (Standard Deviation) | 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. |
| New-onset Postoperative Atrial Fibrillation Complication | 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. |
| All-cause 30-day Hospital Readmission | 30 days after discharge | All-cause 30-day hospital readmission rate based on medical record data. |
| Total Opioid IV Narcotic Burden (Mean) in mg | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Hospital Re-admission Within 30 Days | 30 days | Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 136 |
| 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. | 136 |
| Total | 272 |
Baseline characteristics
| Characteristic | Reiki/Manual Therapy | Usual Care Quiet Time | Total |
|---|---|---|---|
| Age, Continuous | 62.4 years STANDARD_DEVIATION 11.9 | 62.0 years STANDARD_DEVIATION 12.6 | 62.2 years STANDARD_DEVIATION 12.2 |
| BMI | 28.7 kg/m2 STANDARD_DEVIATION 5.3 | 27.8 kg/m2 STANDARD_DEVIATION 5.2 | 28.2 kg/m2 STANDARD_DEVIATION 5.2 |
| Payor Government (Medicare/Medicaid) + Self Pay | 35 Participants | 40 Participants | 75 Participants |
| Payor Private + Other Inc | 101 Participants | 96 Participants | 197 Participants |
| Primary Diagnosis Cardiac | 95 Participants | 108 Participants | 203 Participants |
| Primary Diagnosis Congenital | 41 Participants | 28 Participants | 69 Participants |
| Race/Ethnicity, Customized Other race/ethnicity | 10 Participants | 12 Participants | 22 Participants |
| Race/Ethnicity, Customized White | 126 Participants | 124 Participants | 250 Participants |
| Region of Enrollment United States | 136 participants | 136 participants | 272 participants |
| Sex: Female, Male Female | 34 Participants | 33 Participants | 67 Participants |
| Sex: Female, Male Male | 102 Participants | 103 Participants | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
All-cause 30-day Hospital Readmission
All-cause 30-day hospital readmission rate based on medical record data.
Time frame: 30 days after discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reiki/Manual Therapy | All-cause 30-day Hospital Readmission | 4 Participants |
| Usual Care Quiet Time | All-cause 30-day Hospital Readmission | 11 Participants |
Primary
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.
Time frame: Post-operative (day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Anxiety | 0.60 mean overall score | Standard Deviation 0.6 |
| Usual Care Quiet Time | Anxiety | 0.78 mean overall score | Standard Deviation 0.86 |
Primary
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.
Time frame: Pre-operative (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Anxiety | 0.81 mean overall score | Standard Deviation 0.77 |
| Usual Care Quiet Time | Anxiety | 0.94 mean overall score | Standard Deviation 0.83 |
Primary
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.
Time frame: Pre-operative (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Depression | 0.31 score on a scale | Standard Deviation 0.46 |
| Usual Care Quiet Time | Depression | 0.42 score on a scale | Standard Deviation 0.58 |
Primary
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.
Time frame: Post-operative (day 3)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Depression | 0.29 mean overall score | Standard Deviation 0.41 |
| Usual Care Quiet Time | Depression | 0.40 mean overall score | Standard Deviation 0.5 |
Primary
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.
Time frame: Days of hospital stay
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Hospital Length of Stay, Days - Mean (Standard Deviation) | 6.3 mean overall days and standard deviation | Standard Deviation 2.6 |
| Usual Care Quiet Time | Hospital Length of Stay, Days - Mean (Standard Deviation) | 6.5 mean overall days and standard deviation | Standard Deviation 2.9 |
Primary
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.
Time frame: Post-operation (from day of surgery until hospital discharge)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reiki/Manual Therapy | New-onset Postoperative Atrial Fibrillation Complication | 46 Participants |
| Usual Care Quiet Time | New-onset Postoperative Atrial Fibrillation Complication | 51 Participants |
Primary
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
Time frame: Post-operative thru day 3 after the 1st intervention/usual care was administered
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reiki/Manual Therapy | Pain Level, Mean Score | 2.5 median and [Q1, Q3] of the mean score |
| Usual Care Quiet Time | Pain Level, Mean Score | 2.5 median and [Q1, Q3] of the mean score |
Primary
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.
Time frame: Post-operative thru day 3 after the 1st intervention/usual care was administered
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reiki/Manual Therapy | Pain Level, Median Score | 1.0 score on a scale |
| Usual Care Quiet Time | Pain Level, Median Score | 1.5 score on a scale |
Primary
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.
Time frame: Paper surveys distributed post-operative (day 3) after final reiki and manual therapies intervention or quiet time sessions were completed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Sleep | 42.7 score on a scale | Standard Deviation 26.1 |
| Usual Care Quiet Time | Sleep | 46.7 score on a scale | Standard Deviation 25.2 |
Primary
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.
Time frame: Paper surveys distributed pre-operative (baseline)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Reiki/Manual Therapy | Sleep | 38.5 score on a scale | Standard Deviation 22.2 |
| Usual Care Quiet Time | Sleep | 39.2 score on a scale | Standard Deviation 22.4 |
Primary
Total Opioid IV Narcotic Burden (Mean) in mg
Data retrieved via a hospital billing database
Time frame: Total opioid IV narcotic medication dose (in milligrams), using morphine equivalent data, during the length of stay, an average 6.4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reiki/Manual Therapy | Total Opioid IV Narcotic Burden (Mean) in mg | 20 morphine milligram equivalents |
| Usual Care Quiet Time | Total Opioid IV Narcotic Burden (Mean) in mg | 18.4 morphine milligram equivalents |
Primary
Total Oral Narcotic Burden (Mean) in Milligarms
Data retrieved via a hospital billing database
Time frame: Total oral narcotic medication dose in milligrams, using morphine equivalent data, during the length of stay, an average 6.4 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Reiki/Manual Therapy | Total Oral Narcotic Burden (Mean) in Milligarms | 60 morphine milligram equivalents |
| Usual Care Quiet Time | Total Oral Narcotic Burden (Mean) in Milligarms | 55.3 morphine milligram equivalents |
Secondary
Number of Participants With Hospital Re-admission Within 30 Days
Number of participants with hospital re-admission within 30 days of discharge. Data retrieved medical record chart review.
Time frame: 30 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Reiki/Manual Therapy | Number of Participants With Hospital Re-admission Within 30 Days | 4 Participants |
| Usual Care Quiet Time | Number of Participants With Hospital Re-admission Within 30 Days | 11 Participants |