Post-Op Massage in Infants With Congenital Heart Disease

Congenital Heart Disease Clinical Trial

Official title:

The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04416230
• Other study ID #: IRB11-00662
• Status: Completed
• Phase: N/A
• Start date: May 1, 2012
• Est. completion date: May 30, 2014

Study information

• Verified date: June 2020
• Source: Ohio State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 30, 2014
• Est. primary completion date: August 3, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 12 Months

Eligibility

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

Related Conditions & MeSH terms

• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases

Intervention

Behavioral:
• massage
The massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back.
• quiet time
During quiet time, the infant 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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	Nationwide Children's Hospital

References & Publications (37)

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* Note: There are 37 references in all — Click here to view all references

Outcome

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