A Hospital-based Postnatal Parent Education Intervention About Infant Immunizations (IIAP)

University of Toronto

Status and phase: Unknown; Phase 3

Conditions: Postpartum Women

Treatments: Behavioral: High intensity intervention; Behavioral: Control; Behavioral: Low intensity intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT01937143

126007 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 3,420 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• mothers rooming in with infants on postnatal ward

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,420 participants in 3 patient groups, including a placebo group

Control

Placebo Comparator group

Description:

General information about infant immunizations at birth of a newborn infant

Treatment:

Behavioral: Control

Low intensity intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: Low intensity intervention

High intensity intervention

Active Comparator group

Description:

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

Treatment:

Behavioral: High intensity intervention