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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04416230
Other study ID # IRB11-00662
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 1, 2012
Est. completion date May 30, 2014

Study information

Verified date June 2020
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date May 30, 2014
Est. primary completion date August 3, 2013
Accepts healthy volunteers No
Gender All
Age group N/A to 12 Months
Eligibility 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 Design


Intervention

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.
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.

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Ohio State University Nationwide Children's Hospital

References & Publications (37)

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Mitchinson AR, Kim HM, Rosenberg JM, Geisser M, Kirsh M, Cikrit D, Hinshaw DB. Acute postoperative pain management using massage as an adjuvant therapy: a randomized trial. Arch Surg. 2007 Dec;142(12):1158-67; discussion 1167. — View Citation

Nerbass FB, Feltrim MI, Souza SA, Ykeda DS, Lorenzi-Filho G. Effects of massage therapy on sleep quality after coronary artery bypass graft surgery. Clinics (Sao Paulo). 2010;65(11):1105-10. — View Citation

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* Note: There are 37 references in allClick here to view all references

Outcome

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