Post-Op Massage in Infants With Congenital Heart Disease

NCT04416230 | Completed

• 1 other identifier: IRB11-00662
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

congenital heart disease; massage; pediatric pain

Outcome Measures

Primary Outcomes (8)

• Post-operative pain score

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

  Daily average for 7 days

• Change in post-operative pain score with intervention

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

  Daily for 7 days

• Heart rate

  heart rate in beats per minute

  Daily average for 7 days

• Respiratory rate

  respiratory rate in breaths per minute

  Daily average for 7 days

• Oxygen saturation

  oxygen saturation percentage

  Daily average for 7 days

• Change in heart rate with intervention

  heart rate in beats per minute

  Daily for 7 days

• Change in respiratory rate with intervention

  respiratory rate in beats per minute

  Daily for 7 days

• Change in oxygen saturation with intervention

  oxygen saturation percentage

  Daily for 7 days

Study Arms (2)

Massage

EXPERIMENTAL

Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study.

Behavioral: massage

Quiet Time

ACTIVE COMPARATOR

Infants randomized to the Quiet Time intervention experienced a 30 minute time during which non-essential clinical caregiving tasks were restricted.

Behavioral: quiet time

Interventions

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.

Massage

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.

Quiet Time

Eligibility Criteria

• Age: 1 Day - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants born with complex congenital heart disease requiring surgical intervention
• less than 12 months old
• undergoing first surgical procedure

You may not qualify if:

• on paralytics post-operatively
• cardiorespiratory instability
• on-going cardiac pacing

Sponsors & Collaborators

• Ohio State University: lead
• Nationwide Children's Hospital: collaborator

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• Harrison TM, Brown R, Duffey T, Frey C, Bailey J, Nist MD, Renner L, Fitch J. Effects of Massage on Postoperative Pain in Infants With Complex Congenital Heart Disease. Nurs Res. 2020 Sep/Oct;69(5S Suppl 1):S36-S46. doi: 10.1097/NNR.0000000000000459.

  PMID: 32858717 DERIVED

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Massage

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Tondi M Harrison, PhD, RN

  The Ohio State University and Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Research assistants scoring participant pain were blinded to group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: June 4, 2020
• Study Start: May 1, 2012
• Primary Completion: August 3, 2013
• Study Completion: May 30, 2014
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share