L-WebTIPS for Postoperative Pain in Children
Trial Summary
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?
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.
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
Exclusion Criteria
Timeline
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
Treatment Details
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