Testing Educational Materials in a Paediatric Setting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Immunization |
Behavioral: Pain management education Behavioral: No pain management education |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Testing Educational Materials About Immunizations in a Paediatric Setting |
- Number of pain management strategies utilized [ Time Frame: During immunization ] [ Designated as safety issue: No ]The number of pain management strategies utilized during immunization injections measured post-intervention from videotapes by a blinded assessor.
- Pain during infant immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]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.
- Parent behaviour during infant immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]Parent behaviour during infant immunizations, as measured by Measure of Adult and Infant Soothing and Distress (MAISD) tool by trained and blinded research assistants.
- Pain during infant immunizations as reported by parents [ Time Frame: During immunization ] [ Designated as safety issue: No ]Pain during immunization appointments, as reported by parents using the Numerical Rating Scale (NRS), in real-time.
- Parent-reported satisfaction with immunization experience [ Time Frame: During immunization ] [ Designated as safety issue: No ]Parent-reported satisfaction with their immunization experience in their infant during immunization appointments on a 5-point Likert scale.
- Duration of infant crying during immunizations [ Time Frame: During immunization ] [ Designated as safety issue: No ]Duration of infant crying during infant immunizations, measured in seconds, will be assessed from videotapes by a trained and blinded assessor.
- Pain during infant immunizations [ Time Frame: During immunizations ] [ Designated as safety issue: No ]Pain during infant immunizations will be assessed by researchers, in real time, using the Numerical Rating Scale (NRS)
| Estimated Enrollment: | 160 |
| Study Start Date: | November 2012 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Pain management education
Parents are provided with educational material on how to manage child pain during immunization.
|
Behavioral: Pain management education
Parents are provided with educational material on how to manage child pain during immunization.
|
|
No pain management education
Control - parents receive general information about childhood immunization.
|
Behavioral: No pain management education
Control - parents receive general information about childhood immunization.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Anna Taddio, PhD | 416-978-8822 | anna.taddio@utoronto.ca |
| Contact: Michael Sgro, MD | 416-864-6060 ext 6560 | sgrom@smh.ca |
| Canada, Ontario | |
| St. Michael's Health Center, Pediatric Clinic. | Recruiting |
| Toronto, Ontario, Canada, M5B 1W8 | |
| Contact: Micheal Sgro, MD 416-864-6060 ext 6560 SgroM@smh.ca | |
| Contact: Anna Taddio, PhD 416-978-8822 anna.taddio@utoronto.ca | |
| Sub-Investigator: Micheal Sgro, MD | |
| Principal Investigator: | Anna Taddio, PhD | University of Toronto |
More Information
No publications provided
| Responsible Party: | Anna Taddio, Associate Professor, University of Toronto |
| ClinicalTrials.gov Identifier: | NCT01713322 History of Changes |
| Other Study ID Numbers: | 12-195C |
| Study First Received: | October 21, 2012 |
| Last Updated: | December 21, 2012 |
| Health Authority: | Canada: Research Ethics Committee |
Keywords provided by University of Toronto:
|
parent education pain management immunization infant |
ClinicalTrials.gov processed this record on June 18, 2013