Congenital Heart Disease
Conditions
Keywords
congenital heart disease, massage, pediatric pain
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.
Interventions
BEHAVIORALmassage
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.
BEHAVIORALquiet 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.
Sponsors
Nationwide Children's Hospital
Ohio State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Masking description
Research assistants scoring participant pain were blinded to group.
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.
Eligibility
Sex/Gender
ALL
Age
1 Days to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain score | Daily average for 7 days | FLACC score: behavioral observation of face, legs, activity, cry, consolability |
| Change in post-operative pain score with intervention | Daily 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 |
| 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 |
| 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 |
Outcome results
None listed