Effectiveness of Parent-Led Interventions in Reducing Inf... | NCT01503060

NCT01503060

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1	Placebo Comparator	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.	Behavioral: Educational Video - Sham Drug: Sucrose Placebo (water) Drug: Lidocaine Placebo
Group 2	Active Comparator	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.	Behavioral: Educational video - Active Drug: Sucrose Placebo (water) Drug: Lidocaine Placebo
Group 3	Active Comparator	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.	Behavioral: Educational video - Active Drug: Sucrose Drug: Lidocaine Placebo
Group 4	Active Comparator	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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Educational video - Active	Behavioral	The active video will instruct parents in techniques related to optimal infant soothing.	Group 2 Group 3 Group 4

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Hypersensitivity to pain	This will be assessed by comparing the pain scores between each active group and the placebo group at 15 months	At 15 month vaccination (Visit 5)

Measure	Description	Time Frame
Effectiveness of interventions	This will be assessed by comparing the pain scores between groups	At 2,4,6,12 month vaccinations (Visit 1-4)

Eligibility Module

Contacts/Locations Module

Name	Role	Phone	Extension	Email
Anna Taddio, PhD	Contact	416-813-6235		anna.taddio@sickkids.ca

Name	Affiliation	Role
Anna Taddio, PhD	The Hospital for Sick Children	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Outpatient Clinic	Recruiting	Toronto	Ontario	M4V 2S2	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28455250	Derived	Taddio A, Riddell RP, Ipp M, Moss S, Baker S, Tolkin J, Dave M, Feerasta S, Govan P, Fletcher E, Wong H, McNair C, Mithal P, Stephens D. A Longitudinal Randomized Trial of the Effect of Consistent Pain Management for Infant Vaccinations on Future Vaccination Distress. J Pain. 2017 Sep;18(9):1060-1066. doi: 10.1016/j.jpain.2017.04.002. Epub 2017 Apr 26.
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Condition Browse Module

ID	Term
D010146	Pain

ID	Term
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module