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Reframing Needle-related Pain

NCT05217563 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 77

Last updated 2023-02-06

No results posted yet for this study

Summary

The present research study aims to examine the efficacy of a brief parent-led memory reframing intervention to foster more adaptive (i.e., more accurate and positive) pain memories and less future needle pain and fear for a two-series needle procedure (approved vaccines to protect against COVID-19; e.g., BioNTech Pfizer). The intervention will draw from recent data and extant memory reframing and narrative-based intervention techniques to promote more accurate/positive pain memories by teaching parents more adaptive styles of reminiscing with their children about a needle procedure (i.e., a COVID-19 vaccine).

Conditions

  • Pain, Procedural

Interventions

BEHAVIORAL

Memory-reframing intervention (Reframe the Pain)

Parents will be taught to reminisce with their children about the vaccination experience by emphasizing positive aspects of the child's pain memory, using less utterances about pain and fear, correcting negative exaggerations in memory, and enhancing children's self-efficacy regarding their ability to cope with pain (e.g., when children used coping methods such as deep breathing, highlighting that they were brave). Parents will be instructed to reminisce with their children about the vaccine experience using the intervention strategies. Parents in the intervention groups will receive text/email reminders to use needle pain management strategies before each second vaccination appointment. Additionally, parents randomized to the intervention groups will receive text/email reminders approximately once every two weeks to use the memory-reframing principles until the second vaccination appointment.

Sponsors & Collaborators

  • Alberta Children's Hospital Research Institute

    collaborator OTHER

  • Solutions for Kids in Pain

    collaborator UNKNOWN

  • University of Calgary

    lead OTHER

Principal Investigators

  • Melanie Noel, PhD · University of Calgary

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2023-01-27
Completion
2023-01-27

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05217563 on ClinicalTrials.gov