Post-Op Massage in Infants With Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

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.
    

Intervention name(s): massage; quiet time
Intervention type(s): Behavioral; Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
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.
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: congenital heart disease; massage; pediatric pain