A Randomized Controlled Trial About Teaching Parents How to Manage Childhood Immunization Pain

University of Toronto

Status and phase: Completed; Phase 3

Conditions: Mothers of Newborn Infants

Treatments: Behavioral: Fact sheet

Study type: Interventional

Funder types: Other

Identifiers

NCT01637779

1000032989 (Other Identifier)

11-0231-E

Details and patient eligibility

About

There is no effect of a parent-directed fact sheet about pain management during childhood immunization and pre-test on parent learning about evidence-based pain relieving methods.

Full description

Over 90% of young children demonstrate severe distress during vaccination. Pain relieving strategies are uncommonly used, despite a plethora of evidence for physical, pharmacological and psychological techniques. Parents commonly report pain as a harm-related concern for childhood immunizations and are dissatisfied with current practices. Unmitigated pain causes long-term adverse sequelae, including; anticipatory fear and hypersensitivity to pain at future procedures in children, and parental non-compliance with immunization schedules. Health providers and parents report the major barrier to routine use of pain management is parental lack of knowledge about effective strategies. Lack of time is reported as a secondary barrier. An educational tool about immunization pain management targeted to parents that can be practically implemented in the clinical setting within usual time constraints is needed.

Enrollment: 120 patients

Sex: Female

Ages: 15 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• new mothers with health full-term infants
• 5 minute Apgar 7 or more

Exclusion criteria

• non-english speaking mothers
• mothers with psychiatric conditions
• infants admitted to intensive care unit

Trial design

120 participants in 4 patient groups, including a placebo group

fact sheet review

Experimental group

Description:

mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward

Treatment:

Behavioral: Fact sheet

control unrelated material

Placebo Comparator group

Description:

mothers will review material unrelated to pain management during immunization then complete a knowledge test

Treatment:

Behavioral: Fact sheet

pre-test, review of fact sheet

Experimental group

Description:

mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test

Treatment:

Behavioral: Fact sheet

pre-test, control unrelated information

Placebo Comparator group

Description:

mothers do a pre-test, then read unrelated material, then repeat the test

Treatment:

Behavioral: Fact sheet