A feasibility and efficacy randomised controlled trial of swaddling for controlling procedural pain in preterm infants

Aims and objectives: This study aimed to investigate the feasibility and efficacy of swaddling to control procedural pain among preterm infants. Background: Swaddling has been recommended for controlling neonatal pain. However, the feasibility for use is uncertain and insufficient evidence is available among preterm infants. Design: A two-arm randomised controlled trial with repeated measures. Method: The study was conducted in a 21-bed neonatal intensive care unit of a regional hospital in Hong Kong. Preterm infants who required heelstick procedure were eligible. Fifty-four preterm infants between 30-37 gestational weeks were randomly assigned to swaddling (n = 27) and control (standard care, n = 27) groups. Pain assessment was performed pre, during, immediate, two, four, six and eight minutes after heelstick procedure using the Premature Infant Pain Profile. Results: The mean Premature Infant Pain Profile scores were significantly reduced in the intervention group compared to the control group during, immediate, two, four, and six minutes after the heelstick procedure. The mean changes of heart rate and oxygen saturation in the intervention group were significantly lower than that of the control group at all measured time points. Notably, the swaddled infants quickly resumed to the baseline level at two minutes whereas the control group reached the stable state at an extended period of six minutes. Conclusion: The findings show that swaddling is feasible and efficacious in controlling pain for heelstick procedure among preterm infants. No adverse effects were observed. Relevance to clinical practice: This article presents the feasibility and efficacy of swaddling as a non-pharmacological and non-invasive intervention to relieve pain during the heelstick procedures among preterm infants. Swaddling can contribute to control minor procedural pain in neonates as one of the simple, safe, cost effective, humanistic and natural analgesia alternatives.