Anxiety, DentalNCT03229720
Evaluation of Audio-Visual Distraction Technique on Child's Anxiety
A study testing Nibiru 3D Virtual Reality Headset in people with Anxiety, Dental and Fear, Dental, run by Cairo University.
Trial summary
Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients. Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Dental, Fear, Dental
- What is being tested?
- Nibiru 3D Virtual Reality Headset
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2017to 1 Sep 2018
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 5-8 years old.
- Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
- Cooperative children and potentially cooperative
- Physically and mentally normal children.
- No previous dental experience involving local anaesthetic administration for the last 2 years
Who cannot join
- Children with visual impairment.
- Children with hearing disabilities.
- Children with disability complicating the dental treatment as trismus, or TMJ problems.
- Children with highly inflamed pulp tissue inducing pain during dental visit.
- Patients or caregivers who refuse to sign the consent.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial
Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.
This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.
Read the detailed description
[I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.
[II] Intervention:
-Steps:
- The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
- The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
- Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
- Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
- Above steps will be done in both visits, with and without the intervention.
- If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
- The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
- The operator will apply topical and dental anaesthesia
- Pulse rate will be measured every 5 minutes.
- The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
- Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.
Intervention modifications:
In case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.
- Conditions
- Anxiety, Dental, Fear, Dental
- Being tested
- Nibiru 3D Virtual Reality Headset
- Keywords
- Audio Visual Distraction
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nibiru 3D Virtual Reality HeadsetDevice
This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.
| Study group | Role | What they receive |
|---|---|---|
| Audio-Visual Distraction Group | Active comparator | In this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group. Receives: Device: Nibiru 3D Virtual Reality Headset |
| Normal Dental Environment Group | No intervention | Normal Dental Environment without any distractions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Facial Image Scale
To measure dental Anxiety by using Facial Image Scale
Measured: Immediately right after the dental visit.
Secondary outcomes (1)
Oxygen Saturation (using Pulse oximetry)
to assess the amount of oxygen saturation and relate to the stress level.
Measured: During the dental visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2017
- Study start1 Sep 2017 (estimated)
- Primary completion1 Jul 2018 (estimated)
- Study completion1 Sep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety, DentalStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherif Adel Khalaf Zakhary, Cairo University
- Investigators
- Mahmoud Hamdy, Professor, Study director, Cairo UniversityNada Wassef, Ass. Prof, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03229720
- Sponsor's protocol ID
- Protocol CairoU
- Status last verified
- Jul 2017
- First submitted
- 23 Jul 2017
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Audio-Visual Distraction Technique Versus Normal Dental Environment for Management of Anxiety in Pediatric Dental Patients, A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03229720
- Acronym / sponsor ID
- Protocol CairoU
- Conditions
- Anxiety, Dental, Fear, Dental
- Keywords
- Audio Visual Distraction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Sep 2017 (estimated)
- Primary completion
- 1 Jul 2018 (estimated)
- Study completion
- 1 Sep 2018 (estimated)
- First posted
- 25 Jul 2017 (actual)
- 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.
Audio-Visual (AV) Distraction is a recent modality introduced to the entertaining market technology for adults and children. Some practitioners started using this modality of distraction in the dental practice to aid in psychological management of patients.
This study is designed to compare between conventional dental visits (No Distraction) and dental visits aided with audio-visual distraction. Providing a safe, comfortable and entertaining dental environment will give pediatric children a better perception regarding the dental environment and motivate them for repetitive dental visits for better dental health care.
Detailed description
[I] Recruitment: Children aged 5~8 years old with teeth decay requiring restorative dental treatment will be randomly selected according to the Intrusion and Extrusion Criteria.
[II] Intervention:
-Steps:
- The operator will select the teeth; child must have decayed tooth requiring restorative dental treatment.
- The visit will be started by using the tell-show-do technique to explain the procedure. After that the Facial Image Scale is validated to assess dental anxiety and will be explained to the child. The dentist will ask the child to choose one of the six faces that best represented his/her current emotional state.
- Pulse oximeter sensor will then be placed and initial pulse rate will be obtained.
- Patient will choose from a bowl a piece of paper to decide if AV-distraction will be used or not.
- Above steps will be done in both visits, with and without the intervention.
- If the toss had AV-distraction, The operator will introduce the Audio-visual device (Virtual Reality Eye Glasses) to the patient and how it works and will allow the patient to choose his favorite show to watch during the dental visit.
- The operator will instruct the patient with the rules that will be applied during the dental visit to assure complete cooperation.
- The operator will apply topical and dental anaesthesia
- Pulse rate will be measured every 5 minutes.
- The operator will allow extra time if the dental visit ended before the child finishes the tv-show.
- Then operator will ask the patient to choose from the face scale diagrams about his anxiety state at the end of the visit.
Intervention modifications:
In case the child interrupted the dental visit for questions or any reason, the last record of pulse oximeter will be repeated.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Audio-Visual Distraction Group | Active comparator | Device: Nibiru 3D Virtual Reality HeadsetIn this arm, the patient will be introduced to the audio-visual distraction device and given some instruction on how to use it and rules while using it. other than that, the dental procedure is as same as the other arm group. |
| Normal Dental Environment Group | No intervention | –Normal Dental Environment without any distractions. |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children aged 5-8 years old.
- Children with decayed teeth requiring pulp therapy (excluding cases with acute pulpitis)
- Cooperative children and potentially cooperative
- Physically and mentally normal children.
- No previous dental experience involving local anaesthetic administration for the last 2 years
Key exclusion criteria (5 listed)
- Children with visual impairment.
- Children with hearing disabilities.
- Children with disability complicating the dental treatment as trismus, or TMJ problems.
- Children with highly inflamed pulp tissue inducing pain during dental visit.
- Patients or caregivers who refuse to sign the consent.
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 |
|---|---|---|
| Nibiru 3D Virtual Reality HeadsetThis device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings. | Device | Audio-Visual Distraction Group |
Primary outcome
Facial Image Scale
Time frame: Immediately right after the dental visit.
To measure dental Anxiety by using Facial Image Scale
1 secondary outcome
Oxygen Saturation (using Pulse oximetry)
Time frame: During the dental visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2017.
- Individual participant dataSharing planned: Undecided
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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.
Mahmoud Hamdy, Professor study director
Cairo University
Nada Wassef, Ass. Prof study chair
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing Nibiru 3D Virtual Reality Headset in people with Anxiety, Dental and Fear, Dental, run by Cairo University.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 25 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sherif A Zakhary, B.D.S (+2001224579366, Sherif_zakhary@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial Image Scale (time frame: Immediately right after the dental visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2017.