Skip to main content
OpenTrials
Completed

NCT Number: NCT04416230

Post-Op Massage in Infants With Congenital Heart Disease

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Congenital Heart Disease Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases

Age range

1 day–12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

massage

Behavioral

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

Behavioral

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.

Primary outcomes

  1. Post-operative pain score

    Time frame: Daily average for 7 days

    FLACC score: behavioral observation of face, legs, activity, cry, consolability

  2. Change in post-operative pain score with intervention

    Time frame: Daily for 7 days

    FLACC score: behavioral observation of face, legs, activity, cry, consolability

  3. Heart rate

    Time frame: Daily average for 7 days

    heart rate in beats per minute

  4. Respiratory rate

    Time frame: Daily average for 7 days

    respiratory rate in breaths per minute

  5. Oxygen saturation

    Time frame: Daily average for 7 days

    oxygen saturation percentage

  6. Change in heart rate with intervention

    Time frame: Daily for 7 days

    heart rate in beats per minute

  7. Change in respiratory rate with intervention

    Time frame: Daily for 7 days

    respiratory rate in beats per minute

  8. Change in oxygen saturation with intervention

    Time frame: Daily for 7 days

    oxygen saturation percentage

Sponsors and collaborators

Lead sponsor

Ohio State University

Other

Collaborators

  • Nationwide Children's Hospital

Registry information

Official study title

The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Jun 4, 2020
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.