Post-Op Massage in Infants With Congenital Heart Disease

June 1, 2020 updated by: Tondi Harrison, Ohio State University

The Effects of Massage on Pain After Pediatric Cardiothoracic Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

65

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 year (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Massage
Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.
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.
ACTIVE_COMPARATOR: Quiet Time
Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.
Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ohio State University

Collaborators

Nationwide Children's Hospital

Investigators

  • Principal Investigator: Tondi M Harrison, PhD, RN, The Ohio State University and Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 1, 2012

Primary Completion (ACTUAL)

August 3, 2013

Study Completion (ACTUAL)

May 30, 2014

Study Registration Dates

First Submitted

May 22, 2020

First Submitted That Met QC Criteria

June 1, 2020

First Posted (ACTUAL)

June 4, 2020

Study Record Updates

Last Update Posted (ACTUAL)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB11-00662

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is not a plan to make individual participant data available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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