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Pain Management Education for Infant Immunizations
Phase 3
Waitlist Available
Led By Anna Taddio, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during immunizations
Awards & highlights
Study Summary
This trial will test whether educational materials can increase the use of pain-relieving strategies by parents during infant immunizations.
Who is the study for?
This trial is for parents of healthy infants who are either 2 or 4 months old and present at routine immunization appointments. Parents must be able to read and understand English. Infants born before 30 weeks gestation, with congenital anomalies, neurological conditions, or whose mothers have psychiatric conditions cannot participate.Check my eligibility
What is being tested?
The study is testing if educational materials about pain management can increase the use of pain-relieving strategies by parents when their infants receive vaccinations. It's a randomized trial where some get the education and others do not.See study design
What are the potential side effects?
Since this trial involves educational materials rather than medical treatments, there are no direct side effects from interventions being studied.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during immunization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during immunization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of pain management strategies utilized
Secondary outcome measures
Duration of infant crying during immunizations
Pain during infant immunizations
Pain during infant immunizations as reported by parents
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Pain management educationExperimental Treatment1 Intervention
Parents are provided with educational material on how to manage child pain during immunization.
Group II: No pain management educationExperimental Treatment1 Intervention
Control - parents receive general information about childhood immunization.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pain management education
2012
Completed Phase 3
~200
No pain management education
2012
Completed Phase 3
~200
Find a Location
Who is running the clinical trial?
University of TorontoLead Sponsor
687 Previous Clinical Trials
1,018,135 Total Patients Enrolled
2 Trials studying Immunizations
317 Patients Enrolled for Immunizations
Unity Health TorontoOTHER
533 Previous Clinical Trials
446,303 Total Patients Enrolled
Anna Taddio, PhDPrincipal InvestigatorUniversity of Toronto
16 Previous Clinical Trials
18,520 Total Patients Enrolled
1 Trials studying Immunizations
120 Patients Enrolled for Immunizations
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- A parent will be with my infant at all vaccine appointments.I am a parent of a healthy 2 or 4-month old baby here for routine shots.My infant was born before 30 weeks of pregnancy.
Research Study Groups:
This trial has the following groups:- Group 1: No pain management education
- Group 2: Pain management education
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you please elaborate on the Pain management education program's safety procedures?
"There is some evidence from past clinical trials to support the efficacy of pain management education, as well as data from multiple rounds of testing to show that it is safe. Therefore, our team at Power gave it a score of 3."
Answered by AI
Are there any available spots left in this clinical trial?
"The clinical trial in question, which was posted on clinicaltrials.gov on 11/1/2012 and last updated on 12/21/2012, is not recruiting patients at this time. Although, there are six other trials actively recruiting patients."
Answered by AI
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