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| Name | Class |
|---|---|
| Nationwide Children's Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Massage | Experimental | Infants randomized to the massage intervention received a 30 minute massage daily for the 7 day study. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tondi M Harrison, PhD, RN | The Ohio State University and Nationwide Children's Hospital | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11866400 | Background | Blakely WP, Page GG. Pathophysiology of pain in critically ill patients. Crit Care Nurs Clin North Am. 2001 Jun;13(2):167-79. No abstract available. | |
| 8460047 | Background | Craig KD, Whitfield MF, Grunau RVE, Linton J, Hadjistavropoulos HD. Pain in the preterm neonate: behavioural and physiological indices. Pain. 1993 Mar;52(3):287-299. doi: 10.1016/0304-3959(93)90162-I. |
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There is not a plan to make individual participant data available.
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| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| D008405 | Massage |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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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.
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Research assistants scoring participant pain were blinded to group.
| 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. |
|
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| 32858717 | Derived | 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. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |