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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

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

Conditions
-----------------
Mothers of Newborn Infants

Intervention / Treatment
-----------------
* Behavioral: Fact sheet


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: fact sheet review<br>mothers will review a fact sheet containing information about pain management during immunization then complete a knowledge test afterward | Behavioral: Fact sheet<br>* fact sheet about pain management during immunization<br>|
| Placebo Comparator: control unrelated material<br>mothers will review material unrelated to pain management during immunization then complete a knowledge test | Behavioral: Fact sheet<br>* fact sheet about pain management during immunization<br>|
| Experimental: pre-test, review of fact sheet<br>mothers do a pre-test, then read a fact sheet about how to manage immunization pain, then repeat the test | Behavioral: Fact sheet<br>* fact sheet about pain management during immunization<br>|
| Placebo Comparator: pre-test, control unrelated information<br>mothers do a pre-test, then read unrelated material, then repeat the test | Behavioral: Fact sheet<br>* fact sheet about pain management during immunization<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| knowledge | maternal knowledge will be evaluated after reading the fact sheet or control (material unrelated to immunization) | 10 minutes after intervention (educational material) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| utilization of pain relieving interventions | maternal self-reported use of pain relieving interventions during routine 2-month infant immunizations | 2 months after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
randomized controlled trial, parent education, pain management, infant, immunization