Clinical Trial Details
— Status: Terminated
Administrative data
NCT number |
NCT05217563 |
Other study ID # |
REB21-1997 |
Secondary ID |
|
Status |
Terminated |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 1, 2022 |
Est. completion date |
January 27, 2023 |
Study information
Verified date |
February 2022 |
Source |
University of Calgary |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial 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).
Description:
Pain is a common experience in childhood. Healthy children who adhere to recommended medical
care undergo up to 20 painful procedures by the age of 5. Pain from, and fear of, medical
experiences are neither short lasting or benign and can influence children long after the
painful stimulus is removed. Children's memories of needle-related, experimental,
post-surgical, and procedural pain are a powerful predictor of future pain experiences, and
are sometimes more influential to future pain than the initial experience of pain itself.
Memory is susceptible to distortion. Negative biases in pain memories (i.e., recalling higher
levels of pain as compared to initial pain report) are associated with higher subsequent
pain, distress, and worse medical compliance. Children who are more anxious and who
experience greater pain are more likely to develop negatively biased pain memories, which
then leads to greater fear and pain at subsequent pain experiences. Parents and adolescents
who think in more catastrophic ways about child pain tend to develop more negatively biased
pain memories months later. In particular, adolescents who felt helpless in the face of pain
(lack of self-efficacy in their ability to deal with pain) prior to surgery went on to
develop more negatively-biased memories. Moreover, parents' catastrophic thinking about child
pain was found to be the single most important predictor of children's memory biases and
subsequent pain trajectories. It has been suggested that parental and child anxiety lead to
memory biases because of the ways in which parents and children talk about pain following
painful events (e.g., by emphasizing threatening aspects of the experience). Needle fear and
vaccine hesitancy have also been argued to play an important role in children's and parent
reactions to needle pain.
There have only been a few studies examining memory reframing interventions in the context of
children's recall of (needle) pain. In a systematic review, existing trials of memory
reframing interventions were found to be efficacious in reducing negative memory biases,
which is thought to be due to increases in self-efficacy. Indeed, parent-child language-based
interactions about past negative events play a powerful role in how autobiographical memories
of those events are subsequently retrieved and reframed. Parent-child narrative style also
influences children's coping and psychological functioning. Young children whose parents are
topic-extending and elaborative (e.g., who ask open-ended questions to pull for richer, more
detailed accounts of the past) and who use emotional language, have children who are more
accurate and detailed in recalling their pasts, which is adaptive.
Recent data provides compelling evidence that parents who reminisce with their children about
surgery using a particular style (e.g., more elaborative, less topic-switching) and content
(e.g., less content about pain, fear, medical procedures; more explanations) have children
who later remember post-surgical pain in a more accurate and positively biased way. In a
recently published pilot randomized controlled trial, the investigators demonstrated that a
parent-led memory-reframing intervention is efficacious in reducing negative biases in
children's memories for post-surgical pain. However, the intervention has not been examined
in the context of needle procedures. The potential impact of the intervention on children's
future pain experiences has not yet been examined. Finally, the parent-led memory-reframing
intervention has only been tested in children aged 4 to 7 years. A recent RCT has
demonstrated that a parent-led memory-reframing intervention is feasible and acceptable in
youth aged 10 to 18 years undergoing major surgeries. Yet, the intervention efficacy for
needle pain in older children is unknown.
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
the 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). All
participating parents will receive evidence-based information on pain management techniques.
Parents randomized to the control group will receive a pamphlet outlining pain management
strategies. Parents randomized to the intervention group will receive this same pamphlet and
additionally receive a pamphlet and video link with memory-reframing instructions based on a
previously published study. The third group will receive the pamphlet outlining pain
management strategies, the memory-reframing pamphlet and video, as well as brief verbal
instructions via telephone or zoom on how to deliver the intervention to their children.
Parents randomized to the intervention groups will receive text reminders to use the
intervention after the vaccine injection.
This study will be the first to test a brief, parent-led intervention aimed at changing the
way children recall their pain after a needle procedure and examine the impact of the
intervention on children's future needle pain intensity and fear at a second vaccine
injection. This study has great potential to contribute an accessible and feasible pediatric
pain management intervention and foster more adaptive pain trajectories and medical
experiences in childhood.
Novelty and urgency. At this moment in time, a global health crisis is unfolding. The need
for vaccinating all population, including children, must outpace the spread of COVID-19 and
its variants. On November 19, 2021, Health Canada approved the Pfizer vaccine for use in
children aged 5 to 11 years in Canada. Only days later parents began booking their children
for these vaccinations. These vaccinations have already started. There is a considerable
challenge that needs to be overcome. Two thirds of children report having needle fears. In
the wake of misinformation and concerns around needle fears and needle pain, vaccine
hesitancy is growing. Approximately 7-8% of parents delay or avoid having their child
vaccinated due to their child's fear of needles. One way to conquer the fears increase
vaccine confidence is by providing children and parents with simple yet effective strategies
for managing needle pain and fear and fostering more positive memories of these procedures to
improve the rate of subsequent vaccine injections. This project aims to achieve these goals.
The need to do this work is urgent.
STUDY AIMS
This 3-arm randomized controlled trial seeks to achieve the following:
Primary Aims
1. To examine the efficacy of a parent-led memory reframing intervention on children's
memories for pain associated with vaccine needle injections.
Hypothesis 1. The magnitude of the intervention effect will differ depending on the
group allocation. Children in the intervention group that will receive the pain
management and memory intervention pamphlets (with a video link) and verbal instructions
(Group 3) will recall needle-related pain in a more accurate or positively biased way as
compared to the intervention group that will receive the pain management and memory
intervention pamphlets (with a video link) (Group 2), followed by the pain management
pamphlet only (Group 1).
2. To examine the efficacy of a parent-led memory reframing intervention on reducing
children's future pain intensity and pain-related fear associated with vaccine needle
injections.
Hypothesis 2. The magnitude of the intervention effect will differ depending on the
group allocation. Children in the intervention group that will receive the pain
management and memory intervention pamphlets (with a video link) and verbal instructions
(Group 3) will report lower levels of pain intensity and pain-related fear associated
with the second vaccine injection shot as compared to the intervention group that will
receive the pain management and memory pamphlets (with a video link) only (Group 2),
followed by the pain management pamphlet only (Group 1).
Secondary Aims
3. To examine the acceptability, feasibility, and adherence of different modes of
intervention delivery.
Hypothesis 3. There will be no significant differences in acceptability and feasibility
across the two pamphlet(s) (with a video link) only intervention groups (Groups 2 and
3). Group 2 (pain management and memory intervention pamphlets (with a video link) only)
would be lower in adherence, as compared to Group 3 (pain management and memory
pamphlets + verbal instructions).
4. To examine the changes in children's and parent self-efficacy and children's expected
levels of pain and pain-related fear.
Hypothesis 4. The magnitude of the intervention effect will differ depending on the group
allocation. Children in the intervention group that will receive the pain management and
memory intervention pamphlets (with a video link) and verbal instructions (Group 3) will
report higher levels of self-efficacy and lower levels of expected pain and pain-related fear
(prior to the second vaccination injection), as compared to children in the that receive the
pain management and memory intervention pamphlets (with a video link) only (Group 2),
followed by the pain management pamphlet only (Group 1). Similarly, parents in the
intervention group that will receive the pain management and memory intervention pamphlets
and verbal instructions (Group 3) will report higher levels of self-efficacy as compared to
children in the intervention group that will receive the pain management and memory pamphlets
(with a video link) only (Group 2), followed by the pain management pamphlet only (Group 1).
Procedure
Participants will be recruited via advertising the study on social media (e.g., Facebook,
Twitter) and through KT collaborators (e.g., Solutions for Kids in Pain [SKIP]). Families
interested in participating in the study will contact the research team and be screened for
eligibility via telephone by the research staff. Eligible participants will provide verbal
consent and will be sent a written consent form via a secure online software (i.e., REDCap)
several days prior to the first vaccine appointment. Caregivers will provide consent for the
child's participation; children, who are 7 years old or over or turn 7 during participation
in the study, will provide assent. Participants will also complete baseline questionnaires
assessing past child's experiences with needle procedures, child's and parent trait anxiety,
needle fears, parent catastrophizing about child's pain, and vaccine hesitancy. Caregivers
will report socio-demographic information.
Upon completion of the consent form, parents will be randomized into one of three groups
using a random numbers generator. Parents in all three groups will receive a pamphlet with
evidence-based information regarding needle pain management (Pain Management Pamphlet).
Caregivers randomized to the two memory intervention groups (Groups 2 & 3) will also receive
the latter pain management pamphlet and a pamphlet outlining the memory reframing principles
and strategies (Memory Reframing Pamphlet with a video link; the video summarizes the memory
reframing principles and is available at
https://www.youtube.com/watch?v=lvCabG6_ekI&ab_channel=MegFoundationforPain). Caregivers
randomized to the intervention group with additional instructions from a researcher (Group 3)
will receive a telephone or video conference call in addition to the intervention pamphlet.
During the call, a trained researcher (i.e., a graduate student or a post-doctoral fellow)
will provide brief 10- to 15-minute verbal instructions on how to use memory-reframing
principles with their child (Intervention Script). Randomization will be conducted by an
external researcher using a computer random number generator.
On the day of the first vaccine appointment, caregivers will receive an online survey link to
have children report their pain intensity and pain-related fear ratings after the vaccine
injection using validated measures (described below). All parents will receive reminders to
use evidence-based needle pain management prior the vaccine appointments. Parents randomized
to the intervention groups will receive a text or an email reminder to use the
memory-reframing strategies after the first vaccine injection. Reminders to use
memory-reframing strategies will be sent once every two weeks until the second vaccine
appointment.
Seven to ten days after the first vaccine injection, children will complete an established
memory interview5 via telephone or video conference with a researcher blinded to group
allocation. During the interview, children will report their memories for pain intensity and
pain-related fear using the same measures as before, however this time based on recall.
Children will also report how much pain intensity and pain-related fear they expect that they
will experience during the second vaccine injection.
On the day of the second vaccine appointment, caregivers will receive an online survey link
to have children report their pain and pain-related fear ratings after the vaccine injection
using the same validated measures as before. Parents will report what pain management and
memory reframing techniques they have used.
Following study completion, parents randomized to the intervention groups will complete brief
measures of intervention acceptability. Forty parents randomized to the memory intervention
groups (20 in each group) will be invited to participate in a brief semi-structured interview
to provide their feedback on intervention. Parents in the control group will receive a
pamphlet and video with memory-reframing principles after they complete the study.