Clinical trial NCT04416230: Post-Op Massage in Infants With Congenital Heart Disease
Official title: The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congenital Heart Disease
Keywords: congenital heart disease
massage
pediatric pain
Lead sponsor: Ohio State University
Sponsor class: OTHER
Collaborators: name: Nationwide Children's Hospital
First posted: 2020-06-04
Enrollment: 65
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The intervention consisted of a massage given by a licensed massage therapist on each of seven consecutive days beginning on the day of surgery (Day 1). The massage included 30 minutes of Swedish massage on the infant's accessible upper extremities, lower extremities, head, face, and back. Standard precautions were used, including proper hand hygiene and the use of gloves when needed for infection control.

Infants randomized to the comparison group received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
Primary purpose: TREATMENT

Brief summary: The primary aims of the proposed study are to pilot test the effectiveness of daily massage on pain and clinical outcomes in infants who have undergone cardiothoracic surgery. The secondary aim is to explore relationships among massage, pain scores, and other variables potentially affecting pain scores, including parental anxiety, severity of cardiac defect, and severity of pain.

Specific Aim 1: To compare effects of massage on infant pain and clinical outcomes between two groups over time: infants receiving post-operative massage seven days post-operatively and infants receiving a comparable time of restricted non-essential caregiving seven days post-operatively.

Specific Aim 2: To compare pain scores and physiologic responses before and after intervention in two groups: infants receiving post-operative massage and infants receiving a comparable time of restricted non-essential caregiving.

Specific Aim 3: To examine potential moderators of pain response in the massage intervention group before and after receiving massage.

Detailed description: We used a two-group randomized clinical trial design with a sample of 60 infants with complex congenital heart disease (CCHD) between 1 day and 12 months of age following their first cardiothoracic surgery. Both groups received standard post-operative care. In addition, Group 1 received a daily 30-minute restricted non-essential direct caregiving time (Quiet Time), and Group 2 received a daily 30-minute massage. Interventions continued for seven consecutive days. Pain was measured 6 times daily using the Face, Legs, Activity, Cry, Consolability Pain Assessment Tool (FLACC). Average daily doses of analgesics were recorded. Heart rates (HR), respiratory rates (RR), and oxygen saturations (SpO2) were recorded continuously. Daily averages and pre- and post- intervention FLACC scores and physiologic responses were analyzed using descriptive statistics, generalized linear mixed models (GLMM) for repeated measures, latent growth models, and/or regression discontinuity analysis. Fentanyl-equivalent narcotic values were used as a time-varying covariate.

Eligibility criteria: Inclusion Criteria:

* Infants born with complex congenital heart disease requiring surgical intervention
* less than 12 months old
* undergoing first surgical procedure

Exclusion Criteria:

* on paralytics post-operatively
* cardiorespiratory instability
* on-going cardiac pacing

Primary outcomes:
measure: Post-operative pain score
timeFrame: Daily average for 7 days
measure: Change in post-operative pain score with intervention
timeFrame: Daily for 7 days
measure: Heart rate
timeFrame: Daily average for 7 days
measure: Respiratory rate
timeFrame: Daily average for 7 days
measure: Oxygen saturation
timeFrame: Daily average for 7 days
measure: Change in heart rate with intervention
timeFrame: Daily for 7 days
measure: Change in respiratory rate with intervention
timeFrame: Daily for 7 days
measure: Change in oxygen saturation with intervention
timeFrame: Daily for 7 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: The Ohio State University and Nationwide Children's Hospital
name: Tondi M Harrison, PhD, RN
role: PRINCIPAL_INVESTIGATOR
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