Prenatal Education About Infant Immunization Pain Management

Immunization Clinical Trial

Official title:

A Prenatal Education Module for Parents to Improve the Use of Pain-management Strategies for Immunization in Two-month Old Infants: a Randomized Controlled Trial of Knowledge Translation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707212
• Other study ID #: 12-0134-E
• Status: Completed
• Phase: Phase 3
• First received: October 11, 2012
• Last updated: October 26, 2013
• Start date: October 2012
• Est. completion date: July 2013

Study information

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

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Immunization

Intervention

Behavioral:
• Pain management education
Education about pain management during infant immunization
• No pain management education
Control - no education about pain management during infant immunization

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Toronto	Mount Sinai Hospital, New York

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infant pain during immunization	Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)	within 2 months of immunization	No
Primary	Utilization of pain management strategies during infant immunization	Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization	within 2 months of immunization	No
Secondary	Attempted use of pain management strategies during infant immunization	Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization	within 2 months of immunization	No
Secondary	Knowledge	Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections	within 2 months of immunization	No