Global Behaviour MeasureNCT02180386
Effect of PlayStation Distraction in the Dental Setting
A study testing Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. in people with Global Behaviour Measure, 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 dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction. Read more about this study
- Who is it for?
- Ages 6 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Global Behaviour Measure
- What is being tested?
- Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2014to Jul 2016
- 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 6 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 6-8 years.
- Patients who required a minimum of 2 visits for restorative treatment.
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: Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting
The aim of the study was to assess whether the behavior, anxiety, and dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.
Read the detailed description
global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate
- Conditions
- Global Behaviour Measure
- Being tested
- Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
- Keywords
- Audiovisual distraction, Pediatric dentistry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.Behavioural
videogame can be considered as a method of distraction.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. Receives: Behavioral: Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global behavior during the treatment
we will use the Frankl Scale
Measured: 14 days
Secondary outcomes (5)
Parental perception of patient's anxiety
we will use the Modified Corah Anxiety Scale Questionnaire
Measured: 14 days
Self-reported anxiety during the treatment
we will use the Venham Picture Test
Measured: 14 days
Dental pain during the treatment
We will use the Wong-Baker Faces Scale
Measured: 14 days
Heart rate during the treatment measures in different time points
We will use the the pulse oximeter
Measured: 14 days
Degree of acceptance of the distraction method by the pediatric patient
"Did you enjoy seeing the cartoon film during the dental visit?" (Yes/No)
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 posted2 Jul 2014 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionJul 2016
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 Global Behaviour MeasureStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 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
- NCT02180386
- Sponsor's protocol ID
- UIC-ODP-3
- Status last verified
- May 2021
- First submitted
- 27 Jun 2014
- Last updated
- 10 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
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
- Effect of PlayStation Distraction on Children's Behavior and Pain in the Dental Setting
- ClinicalTrials.gov ID
- NCT02180386
- Acronym / sponsor ID
- UIC-ODP-3
- Conditions
- Global Behaviour Measure
- Keywords
- Audiovisual distraction, Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Universitat Internacional de CatalunyaUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 2 Jul 2014 (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 dental pain of pediatric patients during dental treatment improves when a video game is played as method of distraction.
Detailed description
global behavior Parental perception of patients' anxiety Patient's anxiety dental pain Heart Rate
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. |
Who may qualify
- Ages
- 6 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients aged 6-8 years.
- Patients who required a minimum of 2 visits for restorative treatment.
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 |
|---|---|---|
| Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.videogame can be considered as a method of distraction. | Behavioural | Experimental group |
Primary outcome
Global behavior during the treatment
Time frame: 14 days
we will use the Frankl Scale
5 secondary outcomes
Parental perception of patient's anxiety
Time frame: 14 days
Self-reported anxiety during the treatment
Time frame: 14 days
Dental 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.
Related trials for Global Behaviour Measure
RecruitingObservational study
AXIS MG Patient Registry
Myasthenia Gravis (MG), Myasthenia Gravis, Generalized
RecruitingObservational study
LHC-CIDI-5 in Hong Kong
Major Depressive Episode (MDE), Major Depressive Disorder (MDD)
Recruiting
Evaluation of Global Smart Drinking Goals Initiative
Binge Drinking, Underage Drinking, Drinking and Driving, Alcohol-Related Harms
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 Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit. in people with Global Behaviour Measure, 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 2 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 NCT02180386, 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.