L-WebTIPS for Postoperative Pain in Children

Overseen By Haydee Cortes, BA

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Irvine

Must not be taking: Psychotropic, Pain medications

Disqualifiers: ASA status IV-V, Non-Latinx, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

120 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{1 2 4 6 7}

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

I am a child of Latinx parents and primarily speak Spanish, but may also speak English.

My child is developing normally according to their age.

My child is generally healthy or has mild to severe but not life-threatening health issues.

Exclusion Criteria

Children whose parents do not identify as Latinx will be excluded from this study

My child does not have a severe systemic disease that is a constant threat to life.

I am not taking any medication for mood or pain that affects my emotions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention Development and Feasibility Testing

Web programming of L-WebTIPS and a feasibility randomized control trial to test the intervention

6 months

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

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of pain intensity, emergence delirium, and parent satisfaction

2 weeks

Daily assessments for 14 days post-surgery

What Are the Treatments Tested in This Trial?

Interventions

• L-WebTIPS

Trial Overview

The study tests L-WebTIPS, a culturally adapted mobile health intervention designed to reduce anxiety, pain, and improve recovery after surgery in Latinx children compared to standard care.

How Is the Trial Designed?

Group I: L-WebTIPS Experimental Treatment 1 Intervention

Group II: L-WebINFO Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of California, Irvine

Lead Sponsor

Trials

580

Recruited

4,943,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

In a study of 472 children undergoing routine dental treatment, 38% experienced post-operative pain (PDP), with the highest incidence occurring after root canal treatments (62.5%) and preformed crowns (60.8%).

The use of analgesic agents was common, with 60.9% of children who experienced PDP receiving pain relief, but the type of anaesthesia used (intrasulcular vs local infiltration) did not increase the incidence of PDP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. Ashkenazi, M., Blumer, S., Eli, I.[2022]

Untreated pain in children after surgery can lead to serious complications, highlighting the importance of effective postoperative pain management.

Recent advancements in pain management techniques, including multimodal approaches and the use of new analgesics, have improved the ability of pediatric anesthesiologists to provide safe and effective pain relief, reducing recovery times and minimizing side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute pain management in children. Verghese, ST., Hannallah, RS.[2022]

Chronic postsurgical pain in children is a significant issue, but it occurs less frequently than in adults, highlighting the need for more research in this area.

Current literature is limited, and there is a call for more prospective studies that include clinical examinations and long-term follow-ups to better understand the prevalence, risk factors, and mechanisms behind chronic postsurgical pain in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Chronic pain after surgery in children. Nikolajsen, L., Brix, LD.[2015]

Severe postoperative pain in children can have long-lasting negative effects, making effective pain management crucial, especially after ambulatory surgery.

The review provides guidelines for evaluating and managing pain in children, highlighting both pharmacological options (opioids and non-opioids) and non-pharmacological techniques (like hypnosis and distraction) to improve pain outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postoperative pain management in children and infants: an update. Brasher, C., Gafsous, B., Dugue, S., et al.[2022]

A comprehensive analysis of 4022 publications on postoperative pain in children revealed that pharmacological treatments and pain prevention strategies are the primary focus of current research, indicating a growing maturity in this field.

The study identified opioid stewardship and regional anesthesia as key trends for future research, highlighting the need for improved management practices in pediatric postoperative pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bibliometric and Visual Analysis of the Current Status and Trends of Postoperative Pain in Children from 1950-2021. Wang, C., Liu, LD., Bai, X.[2022]

Citations

1.

withpower.com

withpower.com/trial/phase-pain-postoperative-8-2023-18efb

L-WebTIPS for Postoperative Pain in Children

In a study of 472 children undergoing routine dental treatment, 38% experienced post-operative pain (PDP), with the highest incidence occurring after root canal ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4367120/

Web-Based Tailored Intervention for Preparation of Parents ...

It was hypothesized that WebTIPS would result in significantly less preoperative anxiety in both children and parents compared to children receiving standard ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4617604/

Pain after surgery in children: clinical recommendations

To summarize recent data related to the safety and efficacy of postoperative analgesia in children that influence clinical practice recommendations.

4.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/jan.14381

The effectiveness of web‐based mobile health ...

Web-based mobile health interventions can reduce children's pre-operative anxiety and increase parental satisfaction.

5.

escholarship.org

escholarship.org/content/qt01q3b6vr/qt01q3b6vr_noSplash_990ccfce2bd2d5b4ee32f9c68a024d85.pdf

HHS Public Access

WebTIPS, which is Web-based, is a transformative alternative in that: 1) It is available 24-hours a day/7 days a week starting 5-days before surgery to 10 days ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4367194/

Web-based Tailored Intervention for Preparation of Parents ...

We surveyed 6 pediatric surgeons of various specialties and incorporated their suggestions for postoperative pain management based on the particular surgery.

7.

jmir.org

jmir.org/2025/1/e68348

Virtual Reality for Pediatric Postoperative Pain Management

Ineffective postoperative pain management affects more than 25% of hospitalized children, leading to increased morbidity, impaired physical ...