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Prenatal Education About Infant Immunization Pain Management

NCT ID: NCT01707212

Last Updated: 2013-10-29

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

197 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2013-07-31

Brief Summary

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There are numerous pain management strategies available for the management of infant immunization pain. The majority of infants, however do not benefit from these interventions, which causes them to suffer pain unnecessarily. This study will assess the impact of educating parents about pain management strategies on their knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

Detailed Description

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There is ample literature outlining effective pain management strategies for immunization including psychological, physical and pharmacological interventions; however their use in clinical practice has been limited. Teaching parents about these strategies in an enriching setting such as prenatal education classes has the potential to increase utilization of these strategies, and empower parents to take on a more active role in the management of their infant's pain during routine immunization. Educating parents about pain-management for infant immunization has not been previously investigated in this setting. The aim of this cluster-randomized controlled trial is to evaluate the effectiveness of an immunization pain-management education module added to the prenatal education program at Mount Sinai Hospital on parental knowledge and behaviour regarding pain management during routine 2-month infant immunization injections.

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

Education about pain management during infant immunization

Group Type EXPERIMENTAL

Pain management education

Intervention Type BEHAVIORAL

Education about pain management during infant immunization

No pain management education

Control - general information about immunization only

Group Type OTHER

No pain management education

Intervention Type BEHAVIORAL

Control - no education about pain management during infant immunization

Interventions

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Pain management education

Education about pain management during infant immunization

Intervention Type BEHAVIORAL

No pain management education

Control - no education about pain management during infant immunization

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* mothers attending weekend prenatal classes
* delivery of a healthy newborn \> 35 weeks gestational age
* available for followup for infant's 2-month immunization

Exclusion Criteria

* mothers who do not plan to immunize their infants
* infant with major birth defect or hospitalized at time of immunization
* mothers who need to attend the prenatal class at a separate time when education not offered
Minimum Eligible Age

16 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Sinai Hospital, New York

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

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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12-0134-E

Identifier Type: -

Identifier Source: org_study_id