An interventional study of massage and quiet time in Congenital Heart Disease, sponsored by Ohio State University. Completed. Open to participants aged 1 Day to 12 Months. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by Ohio State University · Not applicable, Interventional, and Treatment
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.
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.
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This study's enrollment of 65 is below the median of 100 across 1,778 interventional studies indexed under Heart Diseases.
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Exclusion Criteria:
Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.
Behavioral: massage
Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.
Behavioral: quiet time
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.
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.
Post-operative pain score
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Time frame: Daily average for 7 days
Change in post-operative pain score with intervention
FLACC score: behavioral observation of face, legs, activity, cry, consolability
Time frame: Daily for 7 days
Heart rate
heart rate in beats per minute
Time frame: Daily average for 7 days
Respiratory rate
respiratory rate in breaths per minute
Time frame: Daily average for 7 days
Oxygen saturation
oxygen saturation percentage
Time frame: Daily average for 7 days
Change in heart rate with intervention
heart rate in beats per minute
Time frame: Daily for 7 days
Change in respiratory rate with intervention
respiratory rate in beats per minute
Time frame: Daily for 7 days
Change in oxygen saturation with intervention
oxygen saturation percentage
Time frame: Daily for 7 days
No study locations are listed for this record.
Plan to share: No — There is not a plan to make individual participant data available.
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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Ohio State University