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Behavioural Intervention
L-WebTIPS for Postoperative Pain in Children
Orange, CA
N/A
Recruiting
Research Sponsored by University of California, Irvine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Only children who are in the normal range of development will be recruited for this study
Children age 2-7 who are scheduled to undergo outpatient surgery
Must not have
Children with health status defined by ASA status IV-V will be excluded from this study
Children who are taking psychotropic or pain medications that affect emotion modulation will be excluded from this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day of surgery
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to reduce surgical disparities in Latinx children undergoing surgery by using a culturally adapted version of an existing mHealth intervention.
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Who is the study for?
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.Check my eligibility
What is being tested?
The study tests L-WebTIPS, a culturally adapted mobile health intervention designed to reduce anxiety, pain, and improve recovery after surgery in Latinx children compared to standard care.See study design
What are the potential side effects?
As L-WebTIPS is a behavioral intervention involving information provision and coping skills training via mobile devices, it does not have direct medical side effects like drugs do.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child is developing normally according to their age.
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My child, aged 2-7, is scheduled for outpatient surgery.
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Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My child does not have a severe systemic disease that is a constant threat to life.
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I am not taking any medication for mood or pain that affects my emotions.
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My parents do not consent to participate in the study.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ days 1-14 after surgery, once a day
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 1-14 after surgery, once a day
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Child Anxiety
Secondary study objectives
Assess Pediatric Anesthesia Emergence Delirium [Emergence status and Psychometric Evaluation in children]
Assess parent satisfaction outcomes using the National Research Council (NRC) Picker satisfaction survey
Change in children's pain intensity using the Postoperative Pain Measure (PPPM)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: L-WebTIPSExperimental Treatment1 Intervention
Group II: L-WebINFOActive Control1 Intervention
Find a Location
Closest Location:Children's Hospital of Orange County· Orange, CA
Who is running the clinical trial?
University of California, IrvineLead Sponsor
578 Previous Clinical Trials
4,942,997 Total Patients Enrolled
1 Trials studying Postoperative Pain
60 Patients Enrolled for Postoperative Pain
National Institute of Mental Health (NIMH)NIH
3,004 Previous Clinical Trials
2,852,032 Total Patients Enrolled