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Completed

NCT Number: NCT01707212

Prenatal Education About Infant Immunization Pain Management

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.

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Key information

Age range

16 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pain management education

Behavioral

Education about pain management during infant immunization

No pain management education

Behavioral

Control - no education about pain management during infant immunization

Primary outcomes

  1. Utilization of pain management strategies during infant immunization

    Time frame: within 2 months of immunization

    Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization

Secondary outcomes

  1. Attempted use of pain management strategies during infant immunization

    Time frame: within 2 months of immunization

    Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization

  2. Knowledge

    Time frame: within 2 months of immunization

    Parents will answer questions regarding their knowledge about the effectiveness of various pain management strategies for infant immunization injections

Other outcomes

  1. Infant pain during immunization

    Time frame: within 2 months of immunization

    Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS)

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • Mount Sinai Hospital, New York

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 16, 2012
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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