NCT01937143

Brief Summary

Immunization injections are the most common recurring painful medical procedure undertaken in childhood. Numerous evidence-based and feasible interventions are available to mitigate immunization pain, however, there is low uptake of these interventions in clinical practice, revealing a knowledge-to-care gap between what is known about pain and pain management. This is a 4-year single-centre, randomized, parallel 3-group add-on trial that will enrol 3420 mothers hospitalized following the birth of an infant at Mount Sinai Hospital (MSH) in Toronto. The trial will evaluate and compare the impact of two levels of intensity of maternal education about pain management during infant immunizations ('low': pamphlet vs. 'high': pamphlet + video) compared to placebo control after the birth of an infant on maternal behaviour during future infant immunizations at up to 6 months of age (use of analgesic interventions), maternal knowledge and attitudes about pain and pain management up to 6 months after birth.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
3,420

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Oct 2013

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 26, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

3.8 years

First QC Date

August 26, 2013

Last Update Submit

September 19, 2016

Conditions

Postpartum Women

Keywords

parent educationimmunizationvaccinationinfantpain management

Outcome Measures

Primary Outcomes (1)

  • Analgesic utilization

    Parent self-reported use of any of the 3 most effective analgesic interventions (breastfeeding, sugar water, or topical anesthetics) at infant immunization; the specific time period for the outcome assessment is at either 2, 4 or 6 month infant immunization, based on a random allocation process.

    Up to 6 months

Secondary Outcomes (4)

  • Knowledge

    Up to 6 months

  • Attitudes

    Up to 6 months

  • Specific analgesic utilization

    Up to 6 months

  • Immunization compliance

    Up to 6 months

Other Outcomes (1)

  • Attempted analgesic utilization

    Up to 6 months

Study Arms (3)

Control

PLACEBO COMPARATOR

General information about infant immunizations at birth of a newborn infant

Behavioral: Control

Low intensity intervention

ACTIVE COMPARATOR

Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Behavioral: Low intensity intervention

High intensity intervention

ACTIVE COMPARATOR

Pamphlet and video with information about pain management during infant immunizations at birth of a newborn infant

Behavioral: High intensity intervention

Interventions

Low intensity interventionBEHAVIORAL

Pamphlet with information about pain management during infant immunizations at birth of a newborn infant

Low intensity intervention
High intensity interventionBEHAVIORAL

Pamphlet and video with information about pain management during immunizations at birth of a newborn infant

High intensity intervention
ControlBEHAVIORAL

General information about infant immunizations at birth of a newborn infant

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • mothers rooming in with infants on postnatal ward

You may not qualify if:

  • mothers with significant psychiatric conditions
  • mothers unable to communicate in English
  • mothers sharing room whereby another mother already participated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (1)

  • Taddio A, Shah V, Bucci L, MacDonald NE, Wong H, Stephens D. Effectiveness of a hospital-based postnatal parent education intervention about pain management during infant vaccination: a randomized controlled trial. CMAJ. 2018 Oct 22;190(42):E1245-E1252. doi: 10.1503/cmaj.180175.

    PMID: 30348739DERIVED

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Anna Taddio, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Leslie Dan Faculty of Pharmacy

Study Record Dates

First Submitted

August 26, 2013

First Posted

September 9, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2017

Study Completion

September 1, 2018

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

CA(1)