Parent Targeted Interventions in Vaccination Pain Management of Infants

NCT03968432 | Completed

• 1 other identifier: H-04-18-405
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Procedural Pain

Keywords

Childhood Vaccination,; Knowledge Translation,; Pain management,; Parents.

Outcome Measures

Primary Outcomes (1)

• The primary outcome: Feasibility and acceptability of study procedure

  This outcome will be measured by the numbers of completed consent forms, number of completed surveys, and number of lost-to-fallow-up people.

  after the study completion (4 months after the baseline survey)

Secondary Outcomes (1)

• The secondary outcome: increase in use of pain management strategies

  After the intervention (2 months after the baseline survey)

Study Arms (2)

Standard Care

SHAM COMPARATOR

Be Sweet to Babies Videos and Pamphlet. Be Sweet to Babies vaccination pain management videos showing parents how to use breastfeeding, upright secure holding, and a small volume of the sweet solution during vaccination will be used.

Behavioral: Be Sweet to Babies Videos and Pamphlet

Intervention

ACTIVE COMPARATOR

Be Sweet to Babies Videos, pamphlet, and MIAS\&Q. MIAS\&Q includes five questions and statements based on MI approach which was developed by the researcher and was reviewed further by a panel of parent representatives and HCPs representatives and the research team consisting of the supervisor and two Ph.D. committee members. This MIAS\&Q intervention consists of four scaled questions and two open-ended questions and presents brief informative and affirmative questions and statements. This aims to help the parents reflect on their own thoughts, and support them to advocate for the use of the recommended pain management strategies during their infant's vaccination.

Behavioral: MIAS&Q; Behavioral: Be Sweet to Babies Videos and Pamphlet

Interventions

MIAS&Q BEHAVIORAL

There were two interventions compared in this study: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS\&Q. The Be Sweet to Babies vaccination pain management videos and pamphlet were provided to all participants as this information is publicly available, and demonstrates the effectiveness of the evidence-based recommended vaccination pain management strategies for infants. In addition, a pamphlet was used which was developed in partnership with CHEO and Ottawa Public Health as a knowledge translation tool. Those in the intervention arm were also given MIAS\&Q included five questions and statements based on the MI approach consisted of four scaled questions and two open-ended questions, aimed to present brief informative and affirmative questions and statements to help the parents reflect on their own thoughts and support them to advocate for the use of the recommended pain management strategies during their infant's vaccination.

Also known as: MI based affirmation statements and questions

Intervention

Be Sweet to Babies Videos and Pamphlet BEHAVIORAL

The Be Sweet to Babies vaccination pain management videos and pamphlet will be provided to all participants. Be Sweet to Babies vaccination pain management videos showing parents how to use breastfeeding, upright secure holding, and a small volume of sweet solution during vaccination, will be used. This pamphlet is a knowledge translation tool previously developed in partnership with the Children Hospital of Eastern Ontario (CHEO) and Ottawa Public Health and has been publicly available on the Ottawa Public Health Website since June 2013. The content presented about pain management for infants during vaccination is the same information as the video.

Intervention; Standard Care

Eligibility Criteria

• Age: 1 Month - 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Parents of infants,
• Recruited before the infants receive their 2, 4, or 6-month vaccinations,
• Respond to the online invitation,
• Consent to participate in this study
• Parents living in Canada
• Read, speak and understand English sufficiently to understand the videos and complete the surveys.

You may not qualify if:

• Parents who cannot understand, read or communicate in English
• Do not plan to have their infant vaccinated

Sponsors & Collaborators

• University of Ottawa: lead

Study Sites (1)

University of Ottawa

Ottawa, Ontario, Canada

Location

Related Publications (1)

• Modanloo S, Dunn S, Stacey D, Harrison D. The feasibility, acceptability and preliminary efficacy of parent-targeted interventions in vaccination pain management of infants: a pilot randomized control trial (RCT). Pain Manag. 2021 May;11(3):287-301. doi: 10.2217/pmt-2020-0072. Epub 2021 Feb 17.

  PMID: 33593096 DERIVED

MeSH Terms

Conditions

Pain, Procedural; Agnosia

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Candidate

Study Record Dates

• First Submitted: May 13, 2019
• First Posted: May 30, 2019
• Study Start: August 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: May 1, 2019
• Last Updated: May 30, 2019

Record last verified: 2019-05

Locations

CA (1)