Comparing the Analgesic Effects of Four Non-pharmacological Interventions on Term Newborns Undergoing Heel Lance
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Stanford University
- Enrollment
- 236
- Primary Endpoint
- Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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
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.
Investigators
Annette Nasr
Clinical Assistant Professor, Pediatrics
Stanford University
Eligibility Criteria
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
Outcomes
Primary Outcomes
Decrease in Neonatal Pain, Agitation and Sedation Scale (NPASS) scores for newborns receiving non-pharmacologic interventions
Time Frame: 12 month
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.