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Web-based Tailored Intervention Preparation for Surgery for Anxiety (WebTIPS Trial)

N/A
Waitlist Available
Led By Zeev Kain, MD, MBA
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
Children whose health status is American Society of Anesthesiologists (ASA) physical status I-III will be recruited for this study.
Only children who are in the normal range of development will be recruited for this study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 15 minutes for 1-2 hours while patient is in the post-anesthesia care unit
Awards & highlights

WebTIPS Trial Summary

This trial will study whether a tailored internet intervention can reduce anxiety and improve recovery for children undergoing surgery, compared to an attention control group who will only receive general information about anxiety and pain management.

Eligible Conditions
  • Anxiety
  • Pain
  • Postoperative Care

WebTIPS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

WebTIPS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~days 5, 7, and 14 after surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and days 5, 7, and 14 after surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assess children's domains of behavior indicating anxiety [Activity, Emotional expressivity, State of arousal, Vocalization and Use of parents]
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 Faces Pain Scale-Revised (FPS-R)
+7 more
Other outcome measures
Assess children's temperament using the Emotional, Activity, Sociability, and Impulsivity temperament scale (adjusting variable)
Assess parent behavioral coping and style using Miller Behavioral style scale (adjusting variable)

WebTIPS Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: WebTIPSExperimental Treatment1 Intervention
A Tailored Program for Perioperative Anxiety and Pain (WebTIPS) aims at reducing perioperative anxiety and pain in children via an internet and mobile platform with short message service (SMS) two-way communication between a healthcare provider and patient/parent. The Web-based Tailored Intervention Preparation for Surgery (WebTIPS) program is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent surgical experience, and reduced resource utilization during the surgical episode.
Group II: ControlActive Control1 Intervention
Subjects in this attention control group, the Web-based Information (WebINFO) group will not be provided tailored content or access to two-way communication. Instead, this group will only receive basic information regarding the management of perioperative anxiety and postoperative pain via the internet and/or mobile platform.

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Who is running the clinical trial?

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,953 Previous Clinical Trials
2,659,900 Total Patients Enrolled
7 Trials studying Anxiety
4,187 Patients Enrolled for Anxiety
University of California, IrvineLead Sponsor
536 Previous Clinical Trials
1,920,941 Total Patients Enrolled
3 Trials studying Anxiety
4,201 Patients Enrolled for Anxiety
Zeev Kain, MD, MBAPrincipal Investigator - UC Irvine Medical Center, Dept. of Anesthesiology and Perioperative Care
University of California-Irvine Medical Center
Ben Gurion University Of The Negev (Medical School)
Yale New Haven Hospital (Residency)

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~111 spots leftby Mar 2025