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Testing Educational Materials in a Paediatric Setting

NCT ID: NCT01713322

Last Updated: 2012-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

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.

Conditions

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Immunization

Keywords

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parent education pain management immunization infant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Pain management education

Parents are provided with educational material on how to manage child pain during immunization.

Group Type EXPERIMENTAL

Pain management education

Intervention Type BEHAVIORAL

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.

Group Type OTHER

No pain management education

Intervention Type BEHAVIORAL

Control - parents receive general information about childhood immunization.

Interventions

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Pain management education

Parents are provided with educational material on how to manage child pain during immunization.

Intervention Type BEHAVIORAL

No pain management education

Control - parents receive general information about childhood immunization.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Unity Health Toronto

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anna Taddio

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

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St. Michael's Health Center, Pediatric Clinic.

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Anna Taddio, PhD

Role: CONTACT

Phone: 416-978-8822

Email: [email protected]

Michael Sgro, MD

Role: CONTACT

Phone: 416-864-6060

Email: [email protected]

Facility Contacts

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Micheal Sgro, MD

Role: primary

Anna Taddio, PhD

Role: backup

Other Identifiers

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12-195C

Identifier Type: -

Identifier Source: org_study_id