Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
Phase 3
- Conditions
- Pain
- Interventions
- Behavioral: Educational Video - ShamBehavioral: Educational video - Active
- Registration Number
- NCT01503060
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
The aim of this study is to find out the effects of routinely using different types of pain-relieving strategies during routine immunization injections performed in infants.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 352
Inclusion Criteria
- Healthy infants undergoing vaccination.
Exclusion Criteria
- preterm birth (<37 weeks gestation)
- prior hospitalization/surgery (other than postnatal care),
- documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
- mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group 1 Educational Video - Sham * Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 1 Sucrose Placebo (water) * Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 2 Educational video - Active * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 3 Educational video - Active * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 4 Educational video - Active * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 2 Sucrose Placebo (water) * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 1 Lidocaine Placebo * Visit 1-4 (2,4,6,12 month vaccinations): Patients will receive standard care * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 2 Lidocaine Placebo * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 3 Lidocaine Placebo * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 4 Sucrose * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 3 Sucrose * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions. Group 4 Lidocaine * Visit 1-4 (2,4,6,12 month vaccinations): Parents will be taught about managing pain and their infant will be given sugar water and a topical anesthetic * Visit 5 (15 month vaccination): At the last visit all 4 groups will receive all three active interventions.
- Primary Outcome Measures
Name Time Method Hypersensitivity to pain At 15 month vaccination (Visit 5) This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months
- Secondary Outcome Measures
Name Time Method Effectiveness of interventions At 2,4,6,12 month vaccinations (Visit 1-4) This will be assessed by comparing the pain scores between groups
Trial Locations
- Locations (2)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
Outpatient Clinic
🇨🇦Toronto, Ontario, Canada