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Behavioral Intervention

Intervention Group (Pamphlet and video only) for Procedural Pain

N/A
Waitlist Available
Led By Melanie Noel, PhD
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 to 10 days after the first vaccination appointment
Awards & highlights

Study Summary

This trial will test whether a brief parent-led intervention can help kids have more accurate and positive memories of a needle procedure, and reduce fear and pain of needles in the future.

Eligible Conditions
  • Procedural Pain

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 to 10 days after the first vaccination appointment
This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 to 10 days after the first vaccination appointment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child pain during the second vaccination
Child pain-related fear during the second vaccination
Memory for pain during the first vaccination
+1 more
Secondary outcome measures
Acceptability (i.e., participants' perception of the intervention applicability and usefulness, as well as their satisfaction with the intervention)
Adherence
Child and parent self-efficacy
+4 more

Trial Design

3Treatment groups
Active Control
Group I: Intervention Group (Pamphlet and video only)Active Control1 Intervention
Intervention Group (Group 2; Pamphlet and video Only). Parents in this intervention group will receive a pamphlet containing evidence-based information on needle pain management and a pamphlet summarizing memory reframing principles. The pamphlet will have a link to a video summarizing the memory reframing strategies.
Group II: Intervention Group (Pamphlet, video, and verbal Instructions).Active Control1 Intervention
Intervention Group (Group 3; Handout and Verbal Instructions). Parents in this intervention group will receive a pamphlet containing evidence-based information on needle pain management, a pamphlet summarizing memory reframing principles (with a video link), and verbal instructions on how to use the intervention principles with their children. The instructions will be provided via telephone or video conferencing and will last approximately 10 to 15 minutes. Trained graduate students or post-doctoral fellows will deliver the instructions. Similar to previous interventions, to boost mastery of the material, the researcher will provide suggestions for specific questions and remarks to make while reminiscing. The instructions will be audio-recorded to allow fidelity coding.
Group III: Standard CareActive Control1 Intervention
Standard Care Control Group (Group 1). Parents in the standard care control group will receive a pamphlet containing evidence-based information on needle pain management. Parents in the standard care control group will not receive any information regarding pain memory reframing, nor will they be encouraged to talk about their children's pain vaccine injection experience. Parents in the standard care control group will receive text/email reminders to use needle pain management strategies before each second vaccination appointment.

Find a Location

Who is running the clinical trial?

Solutions for Kids in PainUNKNOWN
University of CalgaryLead Sponsor
795 Previous Clinical Trials
874,502 Total Patients Enrolled
Alberta Children's Hospital Research InstituteOTHER
11 Previous Clinical Trials
7,130 Total Patients Enrolled
~23 spots leftby Jun 2025
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