Viewing Study NCT06020677



Ignite Creation Date: 2024-05-06 @ 7:28 PM
Last Modification Date: 2024-10-26 @ 3:07 PM
Study NCT ID: NCT06020677
Status: RECRUITING
Last Update Posted: 2023-10-26
First Post: 2023-02-17

Brief Title: Latinx Children and Surgery
Sponsor: University of California Irvine
Organization: University of California Irvine

Study Overview

Official Title: Latinx Children and Surgery
Status: RECRUITING
Status Verified Date: 2023-10
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Over 60 million persons in the United States US identify themselves as Latinx and 256 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 patients health care trajectory Data from the investigators 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 conduct formative evaluation and conduct 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None