Improving surgical outcomes for Latinx children

Latinx Children and Surgery

This study is testing a mobile health program to help Latinx children aged 2-7 feel less anxious and manage pain better before and after their outpatient surgeries.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 2 Years to 7 Years
• Sex: All
• Sponsor: University of California, Irvine (Academic / other)
• Locations: 1 site (Orange, California)
• Trial ID: NCT06020677 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are Latinx children aged 2-7 who are scheduled for outpatient surgery and primarily speak Spanish.

Not a fit: Patients who do not identify as Latinx or are not scheduled for outpatient surgery may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly reduce anxiety and postoperative pain in Latinx children undergoing surgery.

How similar studies have performed: Previous studies have shown promise in using mobile health interventions to improve surgical outcomes, indicating that this approach may be effective.

Eligibility criteria

Inclusion Criteria:

Children:

1. Children age 2-7 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 this trial is running

Orange, California

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

Study contacts

• Study coordinator: Haydee Cortes, BA

Conditions Pain, Postoperative; Pain, Acute