Prenatal Education About Infant Immunization Pain Management

University of Toronto

Status and phase

Completed

Phase 3

Conditions

Immunization

Treatments

Behavioral: No pain management education

Behavioral: Pain management education

Study type

Interventional

Funder types

Other

Identifiers

NCT01707212

12-0134-E

Details and patient eligibility

About

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.

Full 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.

Enrollment

197 patients

Sex

Female

Ages

16+ years old

Volunteers

Accepts Healthy Volunteers

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