Non-pharmacological Analgesic Effects on Term Newborns

Study Overview
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Brief Summary
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The purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

Detailed Description
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This is an randomized control clinical study. study population is healthy term newborns.Patients were identified by chart review and consent was received by nurse researcher. Newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking. A heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. Pain scoring was assessed by two research nurses after the hell lance and through the procedure. Neonatal Pain, Agitation and Sedation Scale (NPASS) was selected as a pain assessment tool for this study. The average pain score from two research nurses were used for statistical analysis.

Official Title
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Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance

Conditions
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Pain, Breast Feeding

Intervention / Treatment
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* Behavioral: breastfeeding
* Dietary Supplement: oral sucrose
* Behavioral: Skin-to-Skin contact
* Behavioral: Non-nutritive sucking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational Age 38-40 2.5-4.0kg 24-48hours of age Receiving heel lance procedure Apgar>7 at birth NPASS<3 at time of heel lance Exclusion Criteria: Prior heel lance procedure birth trauma forceps or vacuum delivery maternal drug abuse during delivery

Ages Eligible for Study
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Minimum Age: 24 Hours
Maximum Age: 48 Hours

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Newborns received no pain interventions during the procedure | |
| Experimental: Breastfeeding<br>Newborns were breastfed during the procedure | Behavioral: breastfeeding<br>* Newborns were breastfed during the procedure<br>|
| Experimental: Oral Sucrose<br>Newborns were given oral sucrose during the procedure | Dietary Supplement: oral sucrose<br>* Newborns were given oral sucrose during the procedure<br>|
| Experimental: Skin to skin contact<br>Newborns were placed in direct contact with their mothers during the procedure | Behavioral: Skin-to-Skin contact<br>* Newborns were placed in direct contact with their mothers during the procedure<br>|
| Experimental: Non-nutritive sucking<br>Newborns were given a pacifier to suck on during the procedure | Behavioral: Non-nutritive sucking<br>* newborns were given a pacifier to suck on during the procedure<br>* Other names: Pacifier;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions | Neonatal Pain, Agitation and Sedation Scale (NPASS) measures both behavioral and physiological components of pain by evaluating five key elements, and scores pain from 0-10 (Patricia A. Hummel, 2004). The assessment criteria are crying irritability, behavior state, facial expression, extremities tone, and vital signs. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neonates, Non-pharmacological