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Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain

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ClinicalTrials.gov Identifier: NCT01503060
Recruitment Status : Unknown
Verified November 2015 by Anna Taddio, The Hospital for Sick Children.
Recruitment status was:  Recruiting
First Posted : January 2, 2012
Last Update Posted : November 10, 2015
Sponsor:
Information provided by (Responsible Party):
Anna Taddio, The Hospital for Sick Children

Tracking Information
First Submitted Date  ICMJE December 29, 2011
First Posted Date  ICMJE January 2, 2012
Last Update Posted Date November 10, 2015
Study Start Date  ICMJE December 2011
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
Hypersensitivity to pain [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 29, 2011)
Effectiveness of interventions [ Time Frame: At 2,4,6,12 month vaccinations (Visit 1-4) ]
This will be assessed by comparing the pain scores between groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain
Official Title  ICMJE Effectiveness of Parent-Led Interventions in Reducing Infant Hypersensitivity to Pain: A Longitudinal Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Pain
Intervention  ICMJE
  • Behavioral: Educational video - Active
    The active video will instruct parents in techniques related to optimal infant soothing.
  • Behavioral: Educational Video - Sham
    The sham video will provide general information about immunization immunization pain management.
  • Drug: Sucrose Placebo (water)
    Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
  • Drug: Sucrose
    Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
  • Drug: Lidocaine Placebo
    Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
  • Drug: Lidocaine
    Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
Study Arms  ICMJE
  • Placebo Comparator: Group 1
    • 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.
    Interventions:
    • Behavioral: Educational Video - Sham
    • Drug: Sucrose Placebo (water)
    • Drug: Lidocaine Placebo
  • Active Comparator: Group 2
    • 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.
    Interventions:
    • Behavioral: Educational video - Active
    • Drug: Sucrose Placebo (water)
    • Drug: Lidocaine Placebo
  • Active Comparator: Group 3
    • 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.
    Interventions:
    • Behavioral: Educational video - Active
    • Drug: Sucrose
    • Drug: Lidocaine Placebo
  • Active Comparator: Group 4
    • 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:
    • Behavioral: Educational video - Active
    • Drug: Sucrose
    • Drug: Lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: November 9, 2015)
352
Original Estimated Enrollment  ICMJE
 (submitted: December 29, 2011)
312
Study Completion Date  ICMJE Not Provided
Estimated Primary Completion Date April 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

1. Healthy infants undergoing vaccination.

Exclusion Criteria:

  1. preterm birth (<37 weeks gestation)
  2. prior hospitalization/surgery (other than postnatal care),
  3. documented/ suspected sensitivity/allergy to amide anaesthetics/vaccines,
  4. mother plans to breastfeed or to use topical anesthetics or sugar water during injection.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Months to 15 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01503060
Other Study ID Numbers  ICMJE 1000025726
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Anna Taddio, The Hospital for Sick Children
Study Sponsor  ICMJE The Hospital for Sick Children
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Anna Taddio, PhD The Hospital for Sick Children
PRS Account The Hospital for Sick Children
Verification Date November 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP