120 Participants Needed

L-WebTIPS for Postoperative Pain in Children

HC
Overseen ByHaydee Cortes, BA
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of California, Irvine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

Over 60 million persons in the United States (US) identify themselves as Latinx and 25.6% are children under the age of 16. Surgical disparities for adults and children have been identified as a major problem in the US and can be experienced at multiple points along a patient's health care trajectory. Data from the investigator's center indicates that a substantial portion of Latinx children who undergo surgery experience high anxiety and postoperative pain as well as postoperative impairments in psychological and physical functioning as compared to White non-Latin children who undergo surgery. Recent growth in use of mobile devices provides us an opportunity to create low-cost mobile health (mHealth) behavioral interventions to reduce this disparity in surgical outcomes. In a previous National Institutes of Health (NIH) award, the principal investigator (PI) developed and tested an evidence based mHealth tailored intervention (WebTIPS) that aims to prepare and be a companion of a child and their family during a surgical event. WebTIPS aims to enhance the recovery of the child in several ways such as reducing anxiety and pain and is based on information provision, modeling, and teaching of coping skills. WebTIPS, however, was developed and validated with a population of primarily White non-Latinx English-speaking children and their parents. Unfortunately, it is well established that mHealth interventions are significantly less effective when used with specific ethnic minorities unless they underwent a process of cultural adaptation. Over the past 4-years, the investigators have established multiple academic and community collaborations, conducted extensive participatory research with Latinx stakeholders and used the heuristic framework and a modified ecological validity model to culturally adapt WebTIPS. The culturally adapted intervention is called L-WebTIPS. The overall aim of this application is to reduce surgical disparities in a population of Latinx children undergoing surgery. The first phase of this application (R61) includes web programming of L-WebTIPS, and a feasibly randomized control trial (RCT) to test this intervention. The second phase (R33) includes a multi-center RCT which aims to 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. Secondary aims of the R33 include examining the impact of L-WebTIPS on home-based clinical recovery parameters such as pain, analgesic requirements, new onset behavioral changes and return to normal daily activity in Latinx children undergoing outpatient surgery. The investigators also plan to determine if the use of L-WebTIPS reduces anxiety and improve experience among the parents of Latinx children undergoing surgery. Finally, the investigators plan to determine if the use of L-WebTIPS reduces anxiety and enhance experience among the parents of Latinx children undergoing surgery. The investigators submit that using a cultural adaption process for an existing validated intervention will accelerate the process of reducing surgical disparities and bringing an effective intervention to clinical settings and routine use.

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.

How is the treatment L-WebTIPS different from other treatments for postoperative pain in children?

L-WebTIPS is unique because it may incorporate nonpharmacological techniques like hypnosis or distraction, which are not typically part of standard drug-based pain management strategies for children after surgery.12345

Eligibility Criteria

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.
See 1 more

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.
See 3 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: L-WebTIPSExperimental Treatment1 Intervention
Group II: L-WebINFOActive Control1 Intervention

Find a Clinic Near You

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+

Findings from Research

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

References

Post-operative pain and use of analgesic agents in children following intrasulcular anaesthesia and various operative procedures. [2022]
Acute pain management in children. [2022]
Chronic pain after surgery in children. [2015]
Postoperative pain management in children and infants: an update. [2022]
Bibliometric and Visual Analysis of the Current Status and Trends of Postoperative Pain in Children from 1950-2021. [2022]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security