A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

NCT ID: NCT01637779

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-02-28

Brief Summary

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There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

Detailed Description

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Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Conditions

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Mothers of Newborn Infants

Keywords

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randomized controlled trial parent education pain management infant immunization

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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fact sheet review

mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward

Group Type EXPERIMENTAL

Fact sheet

Intervention Type BEHAVIORAL

fact sheet about pain management during immunization

control unrelated material

mothers will review material unrelated to pain management during immunization then complete a knowledge test

Group Type PLACEBO_COMPARATOR

Fact sheet

Intervention Type BEHAVIORAL

fact sheet about pain management during immunization

pre-test, review of fact sheet

mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test

Group Type EXPERIMENTAL

Fact sheet

Intervention Type BEHAVIORAL

fact sheet about pain management during immunization

pre-test, control unrelated information

mothers do a pre-test, then read unrelated material, then repeat the test

Group Type PLACEBO_COMPARATOR

Fact sheet

Intervention Type BEHAVIORAL

fact sheet about pain management during immunization

Interventions

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Fact sheet

fact sheet about pain management during immunization

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* new mothers with health full-term infants
* 5 minute Apgar 7 or more

Exclusion Criteria

* non-english speaking mothers
* mothers with psychiatric conditions
* infants admitted to intensive care unit
Minimum Eligible Age

15 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role lead

Responsible Party

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Anna Taddio

Associate Professor, Leslie Dan Faculty of Pharmacy

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anna Taddio, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

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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1000032989

Identifier Type: OTHER

Identifier Source: secondary_id

11-0231-E

Identifier Type: -

Identifier Source: org_study_id