NCT03968432

Parent Targeted Interventions in Vaccination Pain Management of Infants

Completed NA Last updated 30 May 2019

What this trial tests

NA trial testing MIAS&Q in Procedural Pain in 151 participants. Completed in 1 May 2019.

Timeline

1 August 2018

Primary endpoint
30 December 2018

1 May 2019

Quick facts

Lead sponsor	University of Ottawa
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	supportive care
Enrollment	151
Start date	1 August 2018
Primary completion	30 December 2018
Estimated completion	1 May 2019
Sites	1 location across Canada

Drugs / interventions tested

• MIAS&Q
• Be Sweet to Babies Videos and Pamphlet

Conditions studied

• Procedural Pain — all drugs for Procedural Pain →

Sponsor

University of Ottawa

Who can join

Adults 1 Month to 6 Months, any sex, with Procedural Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The overall aim of this study is to investigate the feasibility, acceptability, preliminary effectiveness and sustainability of parent-targeted interventions for pain management during vaccination of infants. To achieve the goal, a two-phase pilot randomized control trial is planned. Study one, currently in the data collection phase, aims i) to evaluate the feasibility and acceptability of data collection tools, participants' recruitment procedures and implementation process of parent-targeted interventions prior to infant vaccination at two, four, or six months. ii) to evaluate the preliminary effectiveness of parent-targeted interventions prior to infant vaccination in promoting the use of pain management strategies during vaccinations of infants at two, four, or six months. iii) to identify the parent's knowledge, use, intention and recommendation to use the recommended pain management strategies, and facilitators and barriers influencing the implementation of the parent-targeted interventions during vaccinations of infants at two, four, or six months. Methods. This study is a prospective multi-faceted two-armed pilot randomized control trial (RCT). a pilot randomized control trial. The participants are parents of infants, recruited before the infants receive their 2, 4, or 6- month vaccinations, who responded to the online invitation and consent to participate in this study. Parents living in Canada and prior to the infant receiving one of the three vaccinations were invited to participate through an online recruitment process. A sample of 50 parent/infant dyads in each group of control and intervention is estimated to be sufficient to achieve the study's goals. The outcome measurements are being done by five brief study questionnaires; Brief information of the study goals and the researchers' affiliation followed by a hyperlink to the survey were posted on different online platforms. Eligible parents of infants who respond to the study invitation are being randomly allocated to 1 of 2 groups (Intervention and control). There are two interventions in the study one being compared: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS\&Q. After the intervention, the impact of the vaccination pain management video and brochure followed by MIAS\&Q questions are being evaluated by a brief online survey exploring the use of pain management (breastfeeding or sucrose and upright secure holding) during infants' vaccination in both groups. Following that, the opinion of parents about the understandability, applicability, feasibility, and acceptability of this study are evaluated. All data are being collected electronically using REDCap survey tool. SPSS version 23.0 (SPSS Inc, Chicago, Illinois) will be used to perform all descriptive and inferential statistical analyses. NVivo version 11.0 (Qualitative data analysis Software; QSR International Pty Ltd) will be used for content analysis and descriptive statistical analysis and thematic analysis will be used for the analysis of the qualitative data.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The feasibility, acceptability and preliminary efficacy of parent-targeted interventions in vaccination pain management of infants: a pilot randomized control trial (RCT).
   Modanloo S, Dunn S, Stacey D, Harrison D. · · 2021 · cited 4× · PMID 33593096 · DOI 10.2217/pmt-2020-0072