Testing Educational Materials in a Paediatric Setting

Study Overview
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Brief Summary
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Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline, led by Taddio et al., created evidence-based strategies for management of immunization pain. User-friendly educational tools outlining these strategies were made. The goal of cluster randomized controlled trial is to assess whether these educational materials increase utilization of pain-relieving strategies by parents during infant immunizations.

Detailed Description
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Immunization procedures are a common source of iatrogenic pain for infants. A recently developed clinical practice guideline led by Taddio et al. provides evidence-based recommendations for the management of immunization pain in children. User-friendly educational tools based on the guideline have also been developed, including a factsheet and educational video. The primary objective of this study is to assess whether these materials can increase utilization of pain -relieving strategies by parents during immunizations. Parents will be recruited during their infant's 2-month or 4-month scheduled visit to receive either the educational material related to immunization pain management (intervention group) or general information about immunization (control group). The study team will then follow these infants at their current and upcoming immunizations visit and document the pain management strategies utilized, infant pain responses, and parental satisfaction with pain management.

Official Title
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Testing Educational Materials About Immunizations in a Paediatric Setting

Conditions
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Immunization

Intervention / Treatment
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* Behavioral: Pain management education
* Behavioral: No pain management education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Parents of 2 or 4-month old healthy infants during routine immunization appointments Parent accompanies infant at immunization appointments Exclusion Criteria: Parents of infants <30 weeks gestational age (GA) Parents delaying infant immunization for >2 months Parents who are unable to read and understand English Infants with congenital anomalies, neurological conditions, and maternal psychiatric conditions

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pain management education<br>Parents are provided with educational material on how to manage child pain during immunization. | Behavioral: Pain management education<br>* Parents are provided with educational material on how to manage child pain during immunization.<br>|
| Other: No pain management education<br>Control - parents receive general information about childhood immunization. | Behavioral: No pain management education<br>* Control - parents receive general information about childhood immunization.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of pain management strategies utilized | The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor. | During immunization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain during infant immunizations | Pain during infant immunizations, as measured by a validated measure of pain in infants, the Modified Behavioural Pain Scale (MBPS), by trained and blinded research assistants. | During immunization | 
| Parent behaviour during infant immunizations | Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants. | During immunization | 
| Pain during infant immunizations as reported by parents | Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time. | During immunization | 
| Parent-reported satisfaction with immunization experience | Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale. | During immunization | 
| Duration of infant crying during immunizations | Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor. | During immunization | 
| Pain during infant immunizations | Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS) | During immunizations | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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infant, parent education, pain management, immunization