Post-Op Massage in Infants With Congenital Heart Disease

Not Applicable

Completed

• Conditions: Congenital Heart Disease

• Registration Number: NCT04416230
• Lead Sponsor: Ohio State University

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.

Study Timeline

• Study Start: 2012-05-01
• Primary Completion: 2013-08-03
• Study Completion: 2014-05-30
• Study First Submitted: 2020-05-22
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-01
• Last Update Submitted: 2020-06-01
• Study First Posted: 2020-06-04
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative pain score	Daily average for 7 days	FLACC score: behavioral observation of face, legs, activity, cry, consolability
Heart rate	Daily average for 7 days	heart rate in beats per minute
Respiratory rate	Daily average for 7 days	respiratory rate in breaths per minute
Change in respiratory rate with intervention	Daily for 7 days	respiratory rate in beats per minute
Change in oxygen saturation with intervention	Daily for 7 days	oxygen saturation percentage
Change in post-operative pain score with intervention	Daily for 7 days	FLACC score: behavioral observation of face, legs, activity, cry, consolability
Oxygen saturation	Daily average for 7 days	oxygen saturation percentage
Change in heart rate with intervention	Daily for 7 days	heart rate in beats per minute