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Behavioural Intervention

L-WebTIPS for Postoperative Pain in Children

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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up days 1-14 after surgery, once a day
Awards & highlights

Study Summary

This trial aims to reduce surgical disparities in Latinx children undergoing surgery by using a culturally adapted version of an existing mHealth intervention.

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 below
Select...
My child is developing normally according to their age.
Select...
My child, aged 2-7, is scheduled for outpatient surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~child anxiety when the child becomes aware of the mask and ends when they are asleep.
This trial's timeline: 3 weeks for screening, Varies for treatment, and child anxiety when the child becomes aware of the mask and ends when they are asleep. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Child Anxiety
Secondary outcome measures
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 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: L-WebTIPSExperimental Treatment1 Intervention
Group II: L-WebINFOActive Control1 Intervention

Find a Location

Who is running the clinical trial?

University of California, IrvineLead Sponsor
544 Previous Clinical Trials
1,922,923 Total Patients Enrolled
1 Trials studying Postoperative Pain
1,200 Patients Enrolled for Postoperative Pain

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the capacity of this trial still available to accommodate new participants?

"This clinical trial is open for recruitment, as per the information provided on clinicaltrials.gov. The original posting was made September 1st of this year and has been edited since then."

Answered by AI

Are geriatrics over 75 years included in the criteria of this medical experiment?

"The age requirements for inclusion in this clinical trial are between 2 and 7 years old. There are 87 different trials recruiting participants aged 18 or below, while 494 studies seek patients over 65."

Answered by AI

Am I eligible to participate in this research project?

"Eligibility for this clinical trial requires that patients suffer from postoperative pain and are between the ages of two to seven. The total number of participants needed is 120."

Answered by AI

What is the enrollment capacity of this research project?

"Affirmative. Evidence on clinicaltrials.gov indicates that this medical investigation, which was first publicized on September 1st 2023 is actively recruiting. This study demands around 120 participants to be recruited from a single centre."

Answered by AI
~40 spots leftby Aug 2024