Comparison of Usual Care and Distraction (Tablet) in Children 3-5 Years Old

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

137 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-07

Study Completion Date

2019-03-08

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Randomized control trial comparing usual care and distraction (tablet) on anxiety, emergence delirium, sedation/agitation, and vomiting in children 3-5 years old

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Clown Doctors and a Sedative Premedicant for Children Undergoing Surgery

NCT00886314

Insomnia

UNKNOWN NA

Clowns as Treatment for Preoperative Anxiety in Children: A Randomized Controlled Trial

NCT00609960

Pre Operative Anxiety

COMPLETED NA

A Controlled Trial of Daily Cognitive-Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

NCT00369642

Obsessive-Compulsive Disorder

COMPLETED PHASE3

Brief, Remote Treatment of Youth Injection Phobia and Measurement of Novel, Disorder-congruent Cognitive Bias Tasks

NCT04972006

Anxiety Disorder of Childhood

UNKNOWN NA

Efficacy of Targeted Memory Reactivation for Enhancing Exposure Therapy

NCT04663672

Claustrophobia Obsessive-Compulsive Disorder Arachnophobia

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Two group RCT comparing usual care (midazolam) and distraction (tablet) on preoperative anxiety, emergence delirium, sedation/agitation, and vomiting in preschool children 3-5 years old.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1: usual care Group 2: distraction

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Not a blinded study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Usual care

Usual care (midazolam) is administered pre-operatively

Group Type ACTIVE_COMPARATOR

Usual care

Intervention Type OTHER

Anxiolytic ordered by anesthesiologist is usual care

Distraction

Distraction (interactive tablet) is given to children pre-operatively

Group Type EXPERIMENTAL

Distraction

Intervention Type BEHAVIORAL

Distraction (interactive tablet)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Distraction

Distraction (interactive tablet)

Intervention Type BEHAVIORAL

Usual care

Anxiolytic ordered by anesthesiologist is usual care

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Anxiolytic per anesthesia

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 3-5 year old children
* Scheduled for elective surgery
* American Society of Anesthesiologists physical status classification system: I - II

Exclusion Criteria

* Children younger than 3 or older than 6
* Allergy to midazolam
* Cognitive or developmental delays
* American Society of Anesthesiologists physical status classification system: III - VI
* Anesthesia provider determines child is not eligible
* Children that are transferred to ICU after surgery

Minimum Eligible Age

3 Years

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes