Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial

Abstract

Background: Parents have reported that they want to learn how to reduce pain in infants during vaccinations. Our objective was to compare different levels of intensity of postnatal education about pain mitigation on parental self-reported use of interventions at future infant vaccinations.

Methods: We conducted a longitudinal, 3-group parallel, add-on, randomized controlled trial on the postnatal ward of a hospital. New mothers, unaware of the hypothesis, were randomly assigned to 1 of 3 intervention groups and 3 follow-up groups (i.e., 9 groups, 3 × 3). The 3 intervention groups were control (general immunization information), pain pamphlet (pain mitigation information), and pain pamphlet and pain video (pain mitigation information). Both pain mitigation education groups also received general immunization information. The 3 follow-up groups were 2-, 4- and 6-month infant vaccinations. Mothers reported use of breastfeeding, sucrose and topical anesthetics during infant vaccinations in a telephone survey.

Results: Of 3420 participants, follow-up was available for 2549 (75%): 36.1%, 34.2% and 29.7% reported on pain mitigation practices at 2-, 4- and 6-month vaccinations, respectively (p = 0.9). Maternal characteristics did not differ (p > 0.05): mean age, 33.6 years; 58% were primipara. Utilization of any intervention (breastfeeding, sucrose or topical anesthetics) was 53.2%, 61.4% and 63.0% for control, pain pamphlet, and pain pamphlet and pain video groups, respectively (p < 0.001); both pain education groups had higher utilization than the control group, but did not differ from one another. Uptake differed among intervention groups at 2 and 4 months but not at 6 months.

Interpretation: Hospital-based postnatal education increased parental use of pain interventions at infant vaccinations and can be added to existing education.

Trial registration: ClinicalTrials.gov, no. NCT01937143.

Conflict of interest statement

Competing interests: Anna Taddio has received a research grant from Pfizer (investigator initiated) and supplies for a separate study from Natus Medical and Ferndale Pharma Group. Lucie Bucci has received research grants from Pfizer Canada, Merck Canada, Sanofi Pasteur, GlaxoSmithKline and Seqirus Canada. No other competing interests were declared.

© 2018 Joule Inc. or its licensors.

Figures

Figure 1:

Flow diagram showing random allocation of participants, exclusions, follow-up and analysis groups. *Control = participants received a pamphlet and video with general information about immunization. †Pain pamphlet = participants received a pamphlet about pain and a video with general information about immunization (and a pamphlet with general information about immunization). ‡Pain pamphlet and pain video = participants received a pamphlet and video about pain (and a pamphlet and video with general information about immunization).