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NCT06020677 · ClinicalTrials.gov registry record · NA

Latinx Children and Surgery

A NA study of Pain, Postoperative and Pain, Acute, sponsored by University of California, Irvine.

Recruiting
Registry status
NA
Development phase
120
Enrollment target
1
Study location

NCT06020677 is a NA study of Pain, Postoperative and Pain, Acute that is actively recruiting participants, run by University of California, Irvine. The registered enrollment target is 120 participants, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (56% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT06020677, a NA study of Pain, Postoperative and Pain, Acute, is actively recruiting participants, sponsored by University of California, Irvine.

RECRUITING
Registry status
NA
Development phase
120 participants
Enrollment target
1
Study location

Study Summary

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

Interventions

  • OTHER L-WebTIPS

Study Locations (1)

California

  • Children's Hospital of Orange County - Orange

Trial Details

FieldValue
Enrollment Target 120 participants
Start Date 2023-08-23
Est. Completion 2027-08-31
Phase NA

Sponsor

University of California, Irvine

368 total trials

What the Registry Record Tells You About NCT06020677

The ClinicalTrials.gov registry entry for NCT06020677 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 272-participant average among 108 other Pain, Postoperative trials with a reported enrollment target (56% lower). The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Pain, Postoperative appearing as the primary indexed condition, and to 1 intervention - of which L-WebTIPS is the first listed.

NCT06020677 reports 1 study location spanning 1 distinct geographic area - top geographies include California.

Frequently Asked Questions

What is clinical trial NCT06020677 about?

NCT06020677 is a clinical study titled "Latinx Children and Surgery". 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 trajecto...

What is the current status of trial NCT06020677?

This trial is currently recruiting. It is a NA study. The enrollment target is 120 participants. The study started on 2023-08-23. Estimated completion is 2027-08-31.

What conditions does trial NCT06020677 study?

This clinical trial studies the following conditions: Pain, Postoperative, Pain, Acute.

What interventions are being tested in trial NCT06020677?

The interventions under investigation include: L-WebTIPS (OTHER).

Who is sponsoring clinical trial NCT06020677?

This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06020677 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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