N/A
N=84
Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone on Anxiety of Children
Anxiety State · Parent-Child Relations
Bottom Line
View on ClinicalTrials.gov: NCT02246062 ↗Enrolled (actual)
84
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcome: Primary: Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. — 27.8; 24.18; 23.79; 24.98 units on a scale m-YPAS
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- info (Behavioral); smartphone (Behavioral)
- Age
- Pediatric · 4+ yrs
- Sex
- All
- Sponsor
- Faculdade de Ciências Médicas da Santa Casa de São Paulo
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Impact of Preanesthetic Information and Behavioral Intervention Using Smartphone Application on Anxiety of Children Measure by m-YPAS. |
51.13; 30.29; 36.55; 28.23 | — |
Summary
Background: Preoperative Anxiety is a negative factor in anesthetic and surgical experience. Among the strategies for reducing children's anxiety, non-pharmacological strategies are as important as the pharmacological ones, but their its validity is still controversial.
Objectives: The aim of this study is to verify if the information provided to relatives as well as and smartphone application provided to children interferes in prevalence and level of child preoperative anxiety.
Methods: Eighty four children, 4-8 years old, ASA I, II and III, undergoing elective surgical procedures and their relatives are randomly allocated into four groups: control group (CG) where the relative received conventional information about anesthesia; info group (IG), relative received an information leaflet about anesthesia; device group (DG), relative received only conventional verbal information and the child received smartphone application immediately before entering the operating room; device and info group (DIG) relative received a leaflet containing information and the child received smartphone application. Children's anxiety will be assessed using the modified Yale Preoperative Anxiety Scale (m-YPAS) on three occasions: at the ward (W), surgical theater in the waiting room (WR) and at the operating room (OR). Statistics analysis will employ by Kruskall-Wallis and Mann-Whitney tests for prevalence and level of anxiety in the groups.
Eligibility Criteria
Inclusion Criteria
- ASA physical status I, II and III a
- age between 4 and 8 years
- undergoing minor-medium elective surgical procedures
- indication of general anesthesia
- not receive premedication
- parents are not illiterate.
Exclusion Criteria
- psychomotor deficits
- use of psychoactive drugs
- hearing and visual impairment
- previous surgery
- for relatives, illness or mental disorder clinically recognized and decline to participate.
Data sourced from ClinicalTrials.gov (NCT02246062). 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.