Improving surgical outcomes for Latinx children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on addressing surgical disparities experienced by Latinx children, particularly in terms of anxiety and postoperative pain. It utilizes a mobile health intervention called L-WebTIPS, designed to prepare children for outpatient surgery and support them during recovery. The intervention targets children aged 2-7 who are scheduled for surgery and come from Latinx backgrounds, with an emphasis on those who primarily speak Spanish. The goal is to enhance psychological and physical functioning post-surgery through tailored behavioral support.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Children:

1. Children age 2-12 who are scheduled to undergo outpatient surgery.
2. Children of Latinx parents, who speak Spanish as a primary language and who may speak English
3. Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study. ASA status I refers to "patients who are normal and healthy with no known systemic disease". ASA status II refers to "patients who have mild or well-controlled systemic diseases," such as non-insulin dependent diabetes, upper respiratory conditions, well-controlled asthma or allergies. ASA status III refers to patients who have moderate or severe systemic disease, which does limit their activities (e.g., stable angina or diabetes with systemic sequellae). This criteria was chosen as this group of children will typically undergo surgery in an outpatient setting. ASA status IV children will most likely undergo surgery in an inpatient setting and represents a much sicker population of children with different barriers.
4. Only children who are in the normal range of development will be recruited for this study. This will be assessed by report from the parents at the time of recruitment. The rationale for excluding patients with developmental delay is that it is unknown whether parents manage their children's postoperative pain differently than in the general population. To generalize the findings to the general population, children with developmental delays will be excluded.

Exclusion Criteria:

1. Children with health status defined by ASA status IV-V will be excluded from this study. ASA status IV refers to "patients with an incapacitating systemic disease that is a constant threat to life". ASA status V "patients are considered moribund".
2. Children whose parents do not identify as Latinx will be excluded from this study.
3. Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study because of the potential for confounding effects on pain.
4. Children with current malignant or any other disease or pain condition will be excluded as this may impact postoperative pain and thus be a confounding variable.

Parent:

Inclusion Criteria:

1\. Latinx Parents of children who are enrolled in the study who speak Spanish as a primary language and who may speak English.

Exclusion Criteria:

1. Parents who refuse to be part of the study.
2. Parents who do not speak Spanish as the primary language.

Where it's running

• Children's Hospital of Orange County
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Haydee Cortes, BA
• Email: cortesh@hs.uci.edu
• Phone: 7144562838

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.