N/A
N=1,274
An Innovative Tailored Intervention for Improving Children's Postoperative Recovery (WebTIPS)
Anxiety · Pain · Postoperative Behavior
Bottom Line
View on ClinicalTrials.gov: NCT03730259 ↗Enrolled (actual)
1,274
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents] — 43.5; 42.3 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Web-based Tailored Intervention Preparation for Surgery (Other)
- Age
- Pediatric · 1+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Assess Children's Domains of Behavior Indicating Anxiety [Activity, Emotional Expressivity, State of Arousal, Vocalization and Use of Parents] |
43.5; 42.3 | — |
| SECONDARY Assess Pediatric Anesthesia Emergence Delirium [Emergence Status and Psychometric Evaluation in Children] |
8.9; 9.6 | — |
| SECONDARY Change in Children's Pain Intensity Using the Postoperative Pain Measure (PPPM) |
4.89; 6.08; 4.84; 5.88; 3.48; 4.87 | — |
| SECONDARY Change in Children's Postoperative Maladaptive Behaviors Using the Post-Hospitalization-Behavior-Questionnaire for Ambulatory Surgery |
2.99; 3.13; 3.02; 3.10; 2.89; 2.95 | — |
| SECONDARY Change in Children's Return to Normal Activity Using the Pediatric Quality of Life (PedsQL) Questionnaire |
82.3; 78.8; 89.1; 81.3; 80; 75 | — |
| SECONDARY State-Trait Anxiety Inventory (STAI) (Parent Self-report) |
37.7; 40.1; 40.95; 44.50 | — |
| SECONDARY Assess Parent Satisfaction Outcomes Using the National Research Council (NRC) Picker Satisfaction Survey |
2.9; 2.9 | — |
| SECONDARY Children's Postoperative Pain Using the Faces, Legs, Arms, Cry and Consolability Pain Scale (FLACC) |
0.0; 0.0 | — |
| SECONDARY Change in Children's Pain Intensity Using the Faces Pain Scale-Revised (FPS-R) |
1.9; 2.7; 1.2; 2.2 | — |
Summary
The goal of this randomized trial is to examine the effectiveness of a tailored Internet-based Preparation Program (WebTIPS) in reducing anxiety and improving the recovery process in children undergoing surgery. Two hospitals and all parent-child dyads will be randomized to either a Web-based Tailored Intervention Preparation for Surgery (WebTIPS) Group or to a Web-based Information (WebINFO) Group, the attention control group. The WebTIPS group will receive the newly developed intervention with short message service (SMS), while the WebINFO Group will only receive an internet and mobile platform with information on the management of preoperative anxiety and perioperative pain. The aims of this study are to:
Primary aim:
Quality of Clinical Care:
Determine whether and to what extent WebTIPS is more effective than an attention control intervention in reducing preoperative anxiety among children ages 1-12 years old undergoing anesthesia and outpatient surgery.
Secondary aims:
Quality of Clinical Care:
1. Examine the impact of WebTIPS on Post-Anesthesia care unit based postoperative clinical recovery parameters, such as pain and emergence delirium.
2. Examine the impact of WebTIPS on home-based postoperative clinical recovery parameters such as pain, new onset behavioral changes and return to normal daily activity over 2 weeks.
3. Determine if the use of WebTIPS reduces parental preoperative anxiety.
Experience of Care:
Examine the effects of WebTIPS on parental satisfaction with the overall experience of the surgical episode.
Eligibility Criteria
Inclusion Criteria
Children:
- Children scheduled to undergo anesthesia and outpatient surgery.
- 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
Parents:
- Parents of children who are enrolled in the study.
Healthcare Providers:
- Anesthesia care providers in the two study hospitals
- Nurses who provide preoperative nursing care to children who are about to undergo surgery in the two study hospitals
Exclusion Criteria
Children:
- Patients with health status defined by ASA status IV-V
- Children who are not in the normal range of development and who are visually impaired will be excluded from this study.
- Children with visual impairment.
Parents:
- Parents who refuse to be part of the study and whose children are not eligible for the study.
- Parents who are visually impaired.
Healthcare Providers:
- Anesthesiologists who refuse to be part of the study
- Nurses who refuse to be part of the study
Data sourced from ClinicalTrials.gov (NCT03730259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.