Disruptive Global Behavior During Previous Treatment VisitsNCT01643915
Behavior Management Using Audiovisual Tools
A study testing No distraction method and Distraction method in people with Disruptive Global Behavior During Previous Treatment Visits, run by Universitat Internacional de Catalunya at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Disruptive Global Behavior During Previous Treatment Visits
- What is being tested?
- No distraction method and Distraction method
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2012to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- Patients with reduced audiovisual capabilities.
- Patients with psychological disorders.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Universitat Internacional de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
About this study
Official title: Behavior Management Using Audiovisual Tools in Pediatric Dental Patients
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.
Read the detailed description
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.
- Being tested
- No distraction method, Distraction method
- Keywords
- Audiovisual distraction, Pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No distraction methodBehavioural
Patients with conventional treatment. No distraction method during the treatment visits.
Distraction methodBehavioural
Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
Distraction methodBehavioural
Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients with conventional treatment. No distraction method during the treatment visits. Receives: Behavioral: No distraction method |
| Experimental group 1 | Experimental | Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit. Receives: Behavioral: Distraction method |
| Experimental group 2 | Experimental | Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. Receives: Behavioral: Distraction method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global behavior during the treatment
Measured: 14 days
Secondary outcomes (5)
Parental perception of patients' anxiety
Measured: 14 days
Self-reported anxiety during the treatment
Measured: 14 days
Pain during the treatment
Measured: 14 days
Heart rate during the treatment measures in different time points
Measured: 14 days
Degree of acceptance of the distraction method by the pediatric patient
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2012 (estimated)
- Study startSep 2012
- Primary completionJul 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Disruptive Global Behavior During Previous Treatment VisitsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat Internacional de Catalunya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Guinot-Jimeno, Universitat Internacional de Catalunya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01643915
- Sponsor's protocol ID
- UIC-ODP-2
- Status last verified
- May 2021
- First submitted
- 16 Jul 2012
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Ram D, Shapira J, Holan G, Magora F, Cohen S, Davidovich E. Audiovisual video eyeglass distraction during dental treatment in children. Quintessence Int. 2010 Sep;41(8):673-679.
PubMed 20657857El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.
PubMed 22583875
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavior Management Using Audiovisual Tools in Pediatric Dental Patients
- ClinicalTrials.gov ID
- NCT01643915
- Acronym / sponsor ID
- UIC-ODP-2
- Keywords
- Audiovisual distraction, Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Jul 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 18 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: No distraction methodPatients with conventional treatment. No distraction method during the treatment visits. |
| Experimental group 1 | Experimental | Behavioral: Distraction methodPatients 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 | Experimental | Behavioral: Distraction methodPatients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. |
Who may qualify
- Ages
- 4 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Patients with reduced audiovisual capabilities.
- Patients with psychological disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No distraction methodPatients with conventional treatment. No distraction method during the treatment visits. | Behavioural | Control group |
| Distraction methodPatients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit. | Behavioural | Experimental group 1 |
| Distraction methodPatients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. | Behavioural | Experimental group 2 |
Primary outcome
Global behavior during the treatment
Time frame: 14 days
5 secondary outcomes
Parental perception of patients' anxiety
Time frame: 14 days
Self-reported anxiety during the treatment
Time frame: 14 days
Pain during the treatment
Time frame: 14 days
Heart rate during the treatment measures in different time points
Time frame: 14 days
Degree of acceptance of the distraction method by the pediatric patient
Time frame: 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2021.
- Background: PubMed 20657857Ram D, Shapira J, Holan G, Magora F, Cohen S, Davidovich E. Audiovisual video eyeglass distraction during dental treatment in children. Quintessence Int. 2010 Sep;41(8):673-679.
- Background: PubMed 22583875El-Sharkawi HF, El-Housseiny AA, Aly AM. Effectiveness of new distraction technique on pain associated with injection of local anesthesia for children. Pediatr Dent. 2012 Mar-Apr;34(2):e35-8.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No distraction method and Distraction method in people with Disruptive Global Behavior During Previous Treatment Visits, run by Universitat Internacional de Catalunya at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global behavior during the treatment (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01643915, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2021.