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

Financial & competing interests disclosure

S Modanloo has received International Admission Scholarship and International Doctoral Scholarship from University of Ottawa, Ottawa, Ontario. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.

Ethical conduct of research

The authors state that they have obtained appropriate institutional review board approval or have followed the principles outlined in the Declaration of Helsinki for all human or animal experimental investigations. In addition, for investigations involving human subjects, informed consent has been obtained from the participants involved.

Data sharing statement

The authors certify that this manuscript reports original clinical trial data; clinical trial registration number: NCT03968432. The final data from this will be available from the time of publication to study participants and the journal’s audiences, by publications and knowledge consumer pamphlets.