Clinical trial NCT03968432: Parent Targeted Interventions in Vaccination Pain Management of Infants
Official title: The Feasibility, Acceptability, and Preliminary Effectiveness of Parent Targeted Interventions in Vaccination Pain Management of Infants: A Pilot Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Procedural Pain
Keywords: Childhood Vaccination,
Knowledge Translation,
Pain management,
Parents.
Lead sponsor: University of Ottawa
Sponsor class: OTHER
First posted: 2019-05-30
Enrollment: 151
Sex: ALL
Minimum age (years): 1
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: Early childhood vaccination is the most important public health intervention to protect against life-threatening infectious diseases worldwide. However, vaccinations are painful and result in distress and anxiety for infants and, in many cases, their parents. If vaccination pain is not addressed, this pain can lead to subsequent non-adherence with vaccination schedules, fears of needles and avoidance of health care. Clinical practice guidelines and high-quality synthesized evidence shows that breastfeeding, sucrose, and upright secure holding effectively reduce pain during vaccination in infants. Despite the evidence, these strategies are not consistently used in practice highlighting an important gap in translating this knowledge into practice. Aims. 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. Parents were eligible if they have an infant scheduled to receive their 2, 4, or 6-month routine vaccination as per the childhood immunization schedule of the province the parents are living in, and they read, speak and understand English sufficiently to understand the videos and complete the surveys. 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; Baseline demographic questionnaire, Baseline knowledge questionnaire, Knowledge utilization questionnaire, Acceptability, and feasibility questionnaire. All recruited parents of infants before their 2, 4, or 6-month vaccination were invited to take part in a baseline survey, aimed to assess current awareness, previous use and future intent to use one of the recommended pain care strategies (breastfeeding, sucrose/other sweet solutions and holding). Different methods were taken for online recruiting of the participants. Brief information of the study goals and the researchers' affiliation followed by a hyperlink to the survey were posted on different online platforms. When participants clicked on the survey link, they were directed to a REDCap (Research Electronic Data Capture) survey.

If the respondents are not eligible, a brief message containing a thank-you note and explanation about their in-eligibility to continue the study was sent to them. However, if they meet the listed screening criteria, they are directed to the next page which is the study's consent form. They are invited to read the forms and provide online informed consent to participate in this study. They are then being directed to the next page which is the demographic questionnaires. A hyperlink directs participants to a brief survey asking questions about previous awareness and intention to use specified recommended pain management strategies in their infants' future immunization episodes. In addition, they were asked to provide an email address to be contacted for the following steps of the study. Eligible parents of infants who respond to the study invitation are being randomly allocated to 1 of 2 groups (Intervention and control) in a 1:1 ratio before the infants' 2, 4, or 6-months vaccination. Participants were stratified according to the infant's age of receiving the vaccine (two, four, or six months). 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. The Be Sweet to Babies vaccination pain management videos and pamphlet are provided to all participants. Those in the intervention arm is also be given MIAS\&Q. 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, are used. In addition, the pamphlet is a knowledge translation tool developed in partnership with the Children Hospital of Eastern Ontario (CHEO) and Ottawa Public Health. MIAS\&Q includes five questions and statements based on MI approach consists of four scaled questions and two open-ended questions, aimed to present brief informative and affirmative questions and statements. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Primary outcomes:
measure: The primary outcome: Feasibility and acceptability of study procedure
timeFrame: after the study completion (4 months after the baseline survey)
Secondary outcomes:
measure: The secondary outcome: increase in use of pain management strategies
timeFrame: After the intervention (2 months after the baseline survey)
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: University of Ottawa
state: Ontario
Study officials:
References:
citation: 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.