Immunization
Conditions
Keywords
parent education, pain management, immunization, infant
Brief 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.
Detailed 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.
Interventions
BEHAVIORALPain management education
Education about pain management during infant immunization
BEHAVIORALNo pain management education
Control - no education about pain management during infant immunization
Sponsors
Mount Sinai Hospital, New York
University of Toronto
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
16 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Utilization of pain management strategies during infant immunization | within 2 months of immunization | Parents will self-report utilization of specific pain management strategies during routine 2-month infant immunization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Attempted use of pain management strategies during infant immunization | within 2 months of immunization | Parents will self-reported attempted utilization of specific pain management strategies at 2-month infant immunization |
| Knowledge | 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
| Measure | Time frame | Description |
|---|---|---|
| Infant pain during immunization | within 2 months of immunization | Parents will self-report infant pain during 2-month immunization using an 11-point Numerical Rating Scale (NRS) |
Countries
Canada
Outcome results
None listed