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Post-Op Massage in Infants With Congenital Heart Disease

NCT04416230 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2020-06-04

No results posted yet for this study

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.

Conditions

  • Congenital Heart Disease

Interventions

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.

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.

Sponsors & Collaborators

  • Nationwide Children's Hospital

    collaborator OTHER

  • Ohio State University

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
12 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-01
Primary Completion
2013-08-03
Completion
2014-05-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04416230 on ClinicalTrials.gov