A modified developmental care bundle reduces pain and stress in preterm infants undergoing examinations for retinopathy of prematurity: A randomised controlled trial.

AIMS AND OBJECTIVES: To determine the comparative efficacy of developmental care versus standard care for reducing pain and stress in preterm infants during examinations for retinopathy of prematurity (ROP).

BACKGROUND: ROP examinations are routinely performed in neonatal intensive care units to detect these lesions. Pain scores recorded during and after eye examinations have revealed physiological and behavioural manifestations of pain and stress.

DESIGN: A randomised crossover trial was conducted.

METHODS: Fourteen preterm infants were evaluated. The modified developmental care bundle included environmental modifications, positioning and containment, oxygen supplementation, interaction and approach and cue-based individual care, which were applied before, during and after the ROP examination. The primary outcomes were obtained from pain and stress scores using the premature infant pain profile-revised (PIPP-R) and a behavioural evaluation. The secondary outcomes were recovery time to the baseline of the vital signs and oxygen saturation.

RESULTS: Statistical significances were found in the care type comparison (p = 0.013), time comparison (p < 0.001) and type-by-time interaction (p = 0.005) in the PIPP-R, and also in the care type comparison (p < 0.001), time comparison (p < 0.001) and type-by-time interaction (p = 0.001) in the behavioural evaluation scores using a generalised estimating equation (GEE) analysis. Recovery time for the developmental care (N = 13, mean = 8.6 ± 11.5 min, 95% CI = 1.68-15.57) was significantly shorter than for the standard care (N = 11, mean = 25.5 ± 20.8 min, 95% CI = 11.45-39.46), which was found to be statistically significant according to the Wilcoxon signed-rank test (N = 11, p = 0.003).

CONCLUSIONS: A bundled developmental care intervention significantly reduced pain and stress responses and the time needed for infants to recover their physiological status following the procedure.

RELEVANCE TO CLINICAL PRACTICE: Since the results show the benefits of developmental care in an ROP examination, it can be the practical evidence basis by which to develop a standard of procedure or guideline for clinical practice.