L-WebTIPS for Postoperative Pain in Children
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on reducing anxiety and pain after surgery in Latinx children using a culturally adapted mobile health tool called L-WebTIPS. The goal is to determine if this tool can help Latinx children and their families feel less anxious and experience less pain after outpatient surgery. The trial compares L-WebTIPS to a standard information tool to evaluate which one is more effective. Eligible participants are Latinx children ages 2 to 7, who speak Spanish as their primary language, and are scheduled for outpatient surgery.
As an unphased trial, this study provides a unique opportunity for families to contribute to research that could enhance post-surgery experiences for Latinx children.
Will I have to stop taking my current medications?
The trial requires that children who are taking psychotropic or pain medications that affect emotion modulation be excluded, so if your child is on such medications, they would not be eligible to participate.
What prior data suggests that L-WebTIPS is safe for Latinx children undergoing surgery?
Research has shown that web-based mobile health programs, like L-WebTIPS, are generally safe and helpful. They can reduce anxiety before surgery and increase parental satisfaction with their child's care. Previous studies have not identified any major safety issues with these programs.
L-WebTIPS is a version of the existing program WebTIPS, initially tested with mostly White non-Latinx children, which showed good results in reducing anxiety and pain. L-WebTIPS has been adapted with input from Latinx communities to better meet their needs.
Since this trial tests an app, no drugs are involved, typically resulting in fewer side effects or risks. The main goal is to help children feel less anxious and manage pain better after surgery by providing information and teaching coping skills through the app.
Overall, L-WebTIPS is a promising tool designed to support Latinx children and their families during surgery, with no current evidence of safety concerns.12345Why are researchers excited about this trial?
Researchers are excited about L-WebTIPS because it offers a novel way to manage postoperative pain in children without medication. Unlike traditional treatments that rely on drugs like opioids or NSAIDs, L-WebTIPS is a digital tool designed to provide cognitive and psychological support, potentially reducing the need for pharmaceuticals. This method could minimize side effects associated with medication and improve recovery experiences for young patients.
What evidence suggests that L-WebTIPS is effective for reducing postoperative pain in Latinx children?
Research has shown that online tools like WebTIPS can reduce anxiety in children before surgery and increase parental satisfaction. Early results suggest that WebTIPS lowers anxiety and pain by providing information, examples, and coping strategies. This tool is available at all times, allowing families to prepare for surgery and manage recovery. In this trial, participants will receive either L-WebTIPS, a version specially designed for Latinx children to make the content more relatable and effective, or L-WebINFO, which serves as a control. This adaptation aims to better meet the needs of Latinx children and their families.12467
Are You a Good Fit for This Trial?
This trial is for Latinx children aged 2-7, who speak Spanish and are scheduled for outpatient surgery. They must be generally healthy (ASA I-III) and not on medications affecting emotions. Their parents should identify as Latinx and primarily speak Spanish.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention Development and Feasibility Testing
Web programming of L-WebTIPS and a feasibility randomized control trial to test the intervention
Multi-center Randomized Control Trial
Determine the effectiveness of L-WebTIPS compared to attention control intervention in decreasing postoperative pain, opioids consumption, and lowering anxiety in Latinx children undergoing outpatient surgery
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, emergence delirium, and parent satisfaction
What Are the Treatments Tested in This Trial?
Interventions
- L-WebTIPS
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Irvine
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator