Behavior Management Using Audiovisual Tools

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

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

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-09-30

Brief Summary

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

The aim of the study was to assess whether the behavior, anxiety, and pain of pediatric patients during dental treatment improves when a cartoon film is viewed or a videogame is played as methods of distraction.

Related Clinical Trials

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

Evaluation of Different Modelling Techniques on Child Anxiety (RCT)

NCT03159793

Anxiety

UNKNOWN NA

Effectiveness of Active and Passive Distraction Techniques on Reducing Fear and Anxiety and Improving Oral Health Knowledge of Children Undergoing Extraction in the Dental Operatory- A Randomized Controlled Trial

NCT03247959

Fear Anxiety

UNKNOWN NA

Evaluation of Custom-designed Dental Storybook on the Dental Anxiety and Behavior of Children

NCT06711367

Child Behavior Dental Anxiety

NOT_YET_RECRUITING NA

Efficacy of Film Modelling in Paediatric Dentistry

NCT01908127

Cooperative Behaviour Dental Anxiety

COMPLETED NA

Positive Pre-Visit Imagery Does Not Reduce Dental Anxiety in Children

NCT06966726

Dental Anxiety Dental Fear and Anxiety

COMPLETED NA

Detailed Description

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

Each patient required a minimum of 2 visits for restorative treatment in a mandibular quadrant and had undergone a previous restorative dental experience. All parents or guardians of the children who participated in the study were informed about the study before enrolment, and gave their voluntary consent. Each visit lasted approximately 35 minutes and involved restorative treatment in a mandibular quadrant with an alveolar nerve block. The parents were not present in the operating room during the treatment. The maximum time between the 2 treatment sessions was 2 weeks. Before the start of each treatment session, as a part of the standard process of a paediatric dental visit, the child was given an explanation as to what the visit would comprise, with the aim of interrupting the treatment as little as possible. The children knew at the beginning of the first appointment (control) that they would be able to watch a movie or play a videogame during their next visit.

Conditions

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

Disruptive Global Behavior During Previous Treatment Visits

Study Design

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

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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

Control group

Patients with conventional treatment. No distraction method during the treatment visits.

Group Type ACTIVE_COMPARATOR

No distraction method

Intervention Type BEHAVIORAL

Patients with conventional treatment. No distraction method during the treatment visits.

Experimental group 1

Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.

Group Type EXPERIMENTAL

Distraction method

Intervention Type BEHAVIORAL

Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.

Experimental group 2

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Group Type EXPERIMENTAL

Distraction method

Intervention Type BEHAVIORAL

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Interventions

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

No distraction method

Patients with conventional treatment. No distraction method during the treatment visits.

Intervention Type BEHAVIORAL

Distraction method

Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.

Intervention Type BEHAVIORAL

Distraction method

Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.

Intervention Type BEHAVIORAL

Eligibility Criteria

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

Inclusion Criteria

* Patients aged 4-9 years.
* Patients who required a minimum of 2 visits for restorative treatment.
* Patients who had previously shown disruptive behavior (Frankl Behavior Rating Scale 1 or 2) during dental restorative treatment or pulp therapy.