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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
870,071 Total Patients Enrolled
Alberta Children's Hospital Research InstituteOTHER
11 Previous Clinical Trials
7,130 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Will I be able to partake in this medical research study?

"This investigation is looking to enroll 300 children experiencing pain between the ages of 5 and 11. The criteria for inclusion are as follows: must be able to understand/speak English, have at least one guardian that has consented and can comprehend both written and spoken English, access to the Internet, receive a two-dose COVID-19 vaccine."

Answered by AI

What is the total enrollment of this medical experiment?

"Affirmative. Clinicaltrials.gov's records show that this clinical trial, first announced on February 1st 2022, is actively searching for participants. Approximately 300 patients are required across one medical site."

Answered by AI

Does this trial include participants aged 35 and over?

"Patients aged between 5 and 11 are eligible to join this clinical trial. For those below 18 or over 65, there are 13 studies available for the former age group and five targeted at seniors."

Answered by AI

Is recruitment still ongoing for this clinical experiment?

"Affirmative. According to the data hosted on clinicaltrials.gov, this clinical trial is currently recruiting patients--it was posted on February 1st 2022 and most recently updated May 16th 2022 with a need for 300 participants from one site."

Answered by AI

What results does the team behind this clinical trial hope to obtain?

"This clinical trial, within the pre-defined duration of 6 to 8 weeks post initial vaccination (subject to alteration depending on Canada Health regulations), seeks to improve pain remembrance from the first round of inoculation. Secondary objectives include Adherence - self-reported utilisation of various techniques for managing discomfort and altering memories; Feasibility - recruitment/enrollment rates, completion statistics and researchers'/parents' ratings regarding motivation levels, understanding of intervention and rapport with personnel in verbal instruction groups; Child Self-Efficacy - children's ability to rate their own efficacy against COVID vaccine shot related pain through an 11 point Likert scale (with"

Answered by AI
~24 spots leftby May 2025