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

A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01637779

Enrollment

120

Registered

2012-07-11

Start date

2012-07-31

Completion date

2013-02-28

Last updated

2013-10-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mothers of Newborn Infants

Keywords

randomized controlled trial, parent education, pain management, infant, immunization

Brief summary

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

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.

Interventions

BEHAVIORALFact sheet

fact sheet about pain management during immunization

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
knowledge	10 minutes after intervention (educational material)	maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)

Secondary

Measure	Time frame	Description
utilization of pain relieving interventions	2 months after intervention	maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026