Non-pharmacological Analgesic Effects on Term Newborns

Stanford University

Status: Completed

Conditions: Breast Feeding; Pain

Treatments: Behavioral: Skin-to-Skin contact; Behavioral: breastfeeding; Behavioral: Non-nutritive sucking; Dietary Supplement: oral sucrose

Study type: Interventional

Funder types: Other

Identifiers

NCT03421158

31216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 236 patients

Sex: All

Ages: 24 to 48 hours old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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236 participants in 5 patient groups

Control

No Intervention group

Description:

Newborns received no pain interventions during the procedure

Breastfeeding

Experimental group

Description:

Newborns were breastfed during the procedure

Treatment:

Behavioral: breastfeeding

Oral Sucrose

Experimental group

Description:

Newborns were given oral sucrose during the procedure

Treatment:

Dietary Supplement: oral sucrose

Skin to skin contact

Experimental group

Description:

Newborns were placed in direct contact with their mothers during the procedure

Treatment:

Behavioral: Skin-to-Skin contact

Non-nutritive sucking

Experimental group

Description:

Newborns were given a pacifier to suck on during the procedure

Treatment:

Behavioral: Non-nutritive sucking