The feasibility, acceptability and preliminary efficacy of parent-targeted interventions in vaccination pain management of infants: a pilot randomized control trial (RCT)

Abstract

Aim: To evaluate the feasibility, acceptability and preliminary efficacy of parent interventions for improving the use of pain management strategies during vaccination of infants, a two-armed pilot randomized control trial (RCT) was conducted. Materials & methods: 151 parents were randomized in two groups: Group 1) 'Be Sweet to Babies' videos and a tip sheet (n = 76); Group 2) As per Group 1 plus a motivational interviewing informed Affirmative Statements and Questions (AS&Q) (n = 75). Results & conclusion: Feasibility was evaluated by success of the recruitment (151 people in a week), rates of completed consent forms (85%), and surveys (59%). Over 94% satisfaction with interventions, processes and 88% intention to recommend the strategies to others determined the acceptability. Preliminary efficacy was evident by over 95% use of pain management strategies following the interventions. Clinical trial registration number: NCT03968432.

Keywords: acute pain; pain; pain management; parent intervention; pediatric vaccination; pilot randomized controlled trial; vaccination.