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

Mothers of Newborn Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01637779
• Other study ID #: 11-0231-E
• Secondary ID: 1000032989
• Status: Completed
• Phase: Phase 3
• First received: July 8, 2012
• Last updated: October 26, 2013
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: October 2013
• Source: University of Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

• Mothers of Newborn Infants

Intervention

Behavioral:
• Fact sheet
fact sheet about pain management during immunization

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	knowledge	maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)	10 minutes after intervention (educational material)	No
Secondary	utilization of pain relieving interventions	maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations	2 months after intervention	No