Reframing Needle-related Pain

NCT05217563 | Terminated

• 1 other identifier: REB21-1997
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

pediatric pain; parents; needle-related pain; vaccination injection; memory for pain; memory-reframing intervention

Outcome Measures

Primary Outcomes (4)

• Memory for pain during the first vaccination

  Children will be asked to recall the first vaccination appointment and complete a pain intensity rating scale (i.e., Faces Pain Scale-Revised; range of scores 0 to 10; higher scores mean higher levels of pain) based on their memories of that time period. Biases in memory will be defined as the deviation in recalled and initial/experienced pain reports. Similar to our previous research, statistical models predicting pain memories will control for initial pain ratings that correspond to each memory question. Negatively-biased pain memories will be defined as children who remember more pain as compared to their initial pain reports. Positively biased pain memories will be defined as recalled pain that is less than initial pain reports. Accurate memories reflect no difference between recalled and experienced levels of pain.

  7 to 10 days after the first vaccination appointment

• Memory for pain-related fear during the first vaccination

  Children will be asked to recall the first vaccination appointment and complete a pain-related fear rating scale (i.e., Children's Fear Scale; CFS; range of scores 0 to 4; higher scores mean higher levels of pain-related fear) based on their memories of that time period. Biases in memory will be defined as the deviation in recalled and initial/experienced pain-related fear reports. Similar to our previous research, statistical models predicting pain-related fear memories will control for initial pain-related fear ratings that correspond to each memory question. Negatively-biased memories will be defined as children who remember more pain-related fear as compared to their initial pain-related fear reports. Positively biased pain-related fear memories will be defined as recalled pain-related fear that is less than initial pain-related fear reports. Accurate memories reflect no difference between recalled and experienced levels of pain-related fear.

  7 to 10 days after the first vaccination appointment

• Child pain during the second vaccination

  Pain intensity will be assessed using a well-validated single-item faces pain scale (Faces Pain Scale-Revised; FPSR; range of scores 0 to 10; higher scores mean higher levels of pain) by children

  6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)

• Child pain-related fear during the second vaccination

  Children's pain-related fear will be assessed using the Children's Fear Scale (CFS; range of scores 0 to 4; higher scores mean higher levels of pain-related fear).

  6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)

Secondary Outcomes (7)

• Child self-efficacy

  Baseline and 7 to 10 days after the first vaccination appointment

• Child and parent self-efficacy

  Baseline and 7 to 10 days after the first vaccination appointment

• Feasibility of intervention (i.e., how many participants assigned to intervention groups received the intervention)

  Baseline, pre-intervention, post-intervention, follow-up (i.e., 6 to 8 weeks after the first vaccination appointment)

• Acceptability (i.e., participants' perception of the intervention applicability and usefulness, as well as their satisfaction with the intervention)

  6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)

• Adherence

  6 to 8 weeks after the first vaccination appointment (subject to change depending on the Canada Health guidelines)

Study Arms (3)

Standard Care

NO 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.

Intervention Group (Pamphlet and video only)

ACTIVE COMPARATOR

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.

Behavioral: Memory-reframing intervention (Reframe the Pain)

Intervention Group (Pamphlet, video, and verbal Instructions).

ACTIVE COMPARATOR

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.

Behavioral: Memory-reframing intervention (Reframe the Pain)

Interventions

Memory-reframing intervention (Reframe the Pain) BEHAVIORAL

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.

Intervention Group (Pamphlet and video only); Intervention Group (Pamphlet, video, and verbal Instructions).

Eligibility Criteria

• Age: 4 Years - 11 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• are aged between 4 and 11 years old at the time of the recruitment;
• plan to receive a two-dose COVID-19 vaccine;
• are able to understand and speak English;
• have at least one of their caregivers' consent to participate in the study, and this caregiver is able to speak and read English
• have Internet access.

You may not qualify if:

• serious developmental disabilities (e.g., Autism Spectrum Disorder) or speech/language delays, as it may make it difficult for the participants to complete all necessary study tasks (e.g., assent, memory interview);
• child's or caregiver's inability to speak and/or understand English

Sponsors & Collaborators

• University of Calgary: lead
• Alberta Children's Hospital Research Institute: collaborator
• Solutions for Kids in Pain: collaborator

Study Sites (1)

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

MeSH Terms

Conditions

Pain, Procedural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Melanie Noel, PhD

  University of Calgary

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel arm design

Study Record Dates

• First Submitted: December 14, 2021
• First Posted: February 1, 2022
• Study Start: February 1, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: February 6, 2023

Record last verified: 2022-02

Locations

CA (1)