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Completed

NCT Number: NCT01637779

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

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.

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Key information

Conditions

Mothers of Newborn Infants Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

15 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fact sheet

Behavioral

fact sheet about pain management during immunization

Primary outcomes

  1. knowledge

    Time frame: 10 minutes after intervention (educational material)

    maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization)

Secondary outcomes

  1. utilization of pain relieving interventions

    Time frame: 2 months after intervention

    maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations

Sponsors and collaborators

Lead sponsor

University of Toronto

Other

Collaborators

  • The Hospital for Sick Children

Registry information

Official study title

A Randomized Clinical Trial to Evaluate the Impact of a Fact Sheet About Childhood Immunization Pain Management on Parental Knowledge

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jul 11, 2012
Registry last updated
Oct 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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