PainNCT03902158
Use of Virtual Reality Glasses During Anesthesia in Behavior, Anxiety and Pain Perception of Children
A study testing Glasses and Distraction techniques in people with Pain, run by Federal University of Pelotas at 1 site in Brazil.
Trial summary
One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. Read more about this study
- Who is it for?
- Ages 5 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Glasses and Distraction techniques
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteBrazil
- Study dates
- 15 Apr 2019to 1 Aug 2020
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- good general health;
- no prior dental experience involving anesthesia in the last 2 years;
- need for restorative treatment or exodontia under local anesthesia.
Who cannot join
- physical or mental disabilities;
- report of poor behavior during dental treatment.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
School of Dentistry
Pelotas, Rio Grande do Sul, 96015080
Marília L Goettems, PhD, 555332606741, mariliagoettems@hotmail.com
About this study
Official title: Use of Virtual Reality Glasses as an Audiovisual Distraction Technique During Anesthesia in Behavior, Anxiety and Pain Perception in Children
One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).
The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.
Read the detailed description
One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Anxiety is often manifested by children during dental appointments, and may represent a challenge in the dental surgeon's clinical practice. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. In view of the basic techniques used to manage children's behavior, distraction has been widely used to provide a more relaxed and effective experience during dental treatment for children. Thus, this study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized through the draw of envelopes at the time of the service, being 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).
The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman\'s terms using the basic techniques of behavior management, such as the \"tell-show-do\" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98) will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.
- Conditions
- Pain
- Being tested
- Glasses, Distraction techniques
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlassesDevice
The patient will wear virtual reality glasses during anesthesia
Distraction techniquesBehavioural
The patient will undergo distraction techniques
| Study group | Role | What they receive |
|---|---|---|
| Glasses | Experimental | Not described Receives: Device: Glasses; Behavioral: Distraction techniques |
| Distraction techniques | No intervention | No glasses will be used |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perception of pain
Visual analogue scale (VAS) will be used to measure pain immediately after treatment
Measured: 5 minutes after anesthesia, i.e., after anesthesia, VAS will be performed in a maximum of 5 minutes after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start15 Apr 2019 (estimated)
- Primary completion31 Dec 2019 (estimated)
- Study completion1 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Pelotas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maximiliano Sergio Cenci, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03902158
- Sponsor's protocol ID
- PPGO 0028
- Status last verified
- Apr 2019
- First submitted
- 22 Jan 2019
- Last updated
- 3 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality Glasses as an Audiovisual Distraction Technique During Anesthesia in Behavior, Anxiety and Pain Perception in Children
- ClinicalTrials.gov ID
- NCT03902158
- Acronym / sponsor ID
- PPGO 0028
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Federal University of PelotasUniversity, hospital or other
- Study start
- 15 Apr 2019 (estimated)
- Primary completion
- 31 Dec 2019 (estimated)
- Study completion
- 1 Aug 2020 (estimated)
- First posted
- 3 Apr 2019 (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.
One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. This study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized with 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).
The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman's terms using the basic techniques of behavior management, such as the "tell-show-do" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98') will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.
Detailed description
One of the most challenging aspects of Pediatric Dentistry is the management of child behavior. Anxiety is often manifested by children during dental appointments, and may represent a challenge in the dental surgeon's clinical practice. Among the procedures performed, local anesthesia is one of the factors that influence the increase in fear and anxiety in children in relation to dental procedures. In view of the basic techniques used to manage children's behavior, distraction has been widely used to provide a more relaxed and effective experience during dental treatment for children. Thus, this study aims to evaluate the effect of the use of virtual reality glasses as an audiovisual distraction technique during anesthesia in behavior, anxiety and pain perception, comparing it with traditional behavior management techniques. A sample of 44 children was estimated and will be selected with the following inclusion criteria: be between 5 and 9 years of age; good general health; no prior dental experience involving anesthesia in the last 2 years; need for restorative treatment or exodontia under local anesthesia. Children with physical or mental disabilities will be excluded and those who report poor behavior in dental consultations will be excluded. The sample will be randomized through the draw of envelopes at the time of the service, being 22 envelopes for the group that will use the glasses during the procedure(G0) and 22 envelopes containing group that will not use the glasses in consultation (G1).
The treatments will be performed in 2 visits, the first for initial examination, and the other for performing the procedures are either extraction or restorative treatment with the use of local anesthesia. During dental treatment, the dentist will explain the procedure in layman\'s terms using the basic techniques of behavior management, such as the \"tell-show-do\" technique, positive reinforcement, conventional distraction in all consultations. When using the distraction technique with virtual reality during the procedure, the virtual stereo glasses model HDMI-MHL 98 Inches (98) will be used. In all two consultations, VENHAM anxiety will be assessed through VENHAM scale and heart rate measurement at the beginning, during and at the end of the visit, as well as the perception of pain during the procedure (FLACC) and after finishing the service through the FPS-R scale. During the visits, the data will be collected using a previously tested tab. The data will be entered into a worksheet in the Microsoft® Excel® 2016 program and analyzed in the Stata 14.0 program. There will be a single blind blinding: both for the typist and who will analyze the data. A descriptive analysis of the data will be performed, obtaining the absolute and relative frequencies. Comparisons in the outcomes of interest between groups G0 and G1 will be performed using the chi-square test for dichotomous variables and the t-test for comparison of means. A significance level of 5% will be adopted for all analyzes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glasses | Experimental | Device: Glasses, Behavioral: Distraction techniques |
| Distraction techniques | No intervention | –No glasses will be used |
Who may qualify
- Ages
- 5 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- good general health;
- no prior dental experience involving anesthesia in the last 2 years;
- need for restorative treatment or exodontia under local anesthesia.
Key exclusion criteria (2 listed)
- physical or mental disabilities;
- report of poor behavior during dental treatment.
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 |
|---|---|---|
| GlassesThe patient will wear virtual reality glasses during anesthesia | Device | Glasses |
| Distraction techniquesThe patient will undergo distraction techniques | Behavioural | Glasses |
Primary outcome
Perception of pain
Time frame: 5 minutes after anesthesia, i.e., after anesthesia, VAS will be performed in a maximum of 5 minutes after anesthesia
Visual analogue scale (VAS) will be used to measure pain immediately after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glasses and Distraction techniques in people with Pain, run by Federal University of Pelotas at 1 site in Brazil.
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: status not confirmed, as of the sponsor's last update on 3 Apr 2019. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perception of pain (time frame: 5 minutes after anesthesia, i.e., after anesthesia, VAS will be performed in a maximum of 5 minutes after anesthesia). 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 3 Apr 2019.