Anxiety and FearNCT06315816
Virtual Reality Used During Tooth Extraction and Extirpation Treatment
A study testing virtual reality glasses used during tooth extraction and extirpation treatment in people with Anxiety and Fear and Tooth Disease, run by Murat Bektaş at 2 sites in Turkey (Türkiye).
Trial summary
This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety and Fear, Tooth Disease
- What is being tested?
- virtual reality glasses used during tooth extraction and extirpation treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2024to 30 Sep 2024
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children who will between the ages of 7-10,
- Children who have Tooth Extraction
- Children who have Extirpation Treatment
- Have no cognitive development problems,
Who cannot join
- Children who will not want to participate in the study,
- Leave the research during the study,
- Have an audio-visual disorder that could prevent the use of virtual glasses.
Trial locations and contacts
2 sites in 1 country.
Turkey (Türkiye)2 sites
Hakkari University
Hakkari, Merkez
Hakkari University
Hakkari
About this study
Official title: The Effect of Virtual Reality Glasses Used During Tooth Extraction and Extirpation Treatment Under Local Anesthesia on Anxiety and Fear in 7-10 Years Old Children
This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.
Read the detailed description
Aims and Objectives: Virtual reality glasses can be used as a distraction method in dental practices for children. This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.
Design: A randomized controlled experimental study design will use. Methods: The sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. Data collection tools included a Child and Family Information Form, the Children's Fear Scale, and the Child Anxiety Scale-State. During the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. No intervention will apply to the control group. Data will analyz using the Chi-square test, t-test, Shapiro-Wilk, mean, and percentage distributions.
- Conditions
- Anxiety and Fear, Tooth Disease
- Being tested
- virtual reality glasses used during tooth extraction and extirpation treatment
- Keywords
- Tooth extraction, Extirpation, Child, Anxiety, fear, Nursing, virtual reality
- Medical subject headings
- Anxiety Disorders, Tooth Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glasses used during tooth extraction and extirpation treatmentBehavioural
The effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in 7-10 years old children
| Study group | Role | What they receive |
|---|---|---|
| Experimantal | Experimental | The children will ask to choose a three-dimensional cartoon from the list to watch during the procedure, it will run, the mobile phone will placed into the virtual reality glasses, and the children wear the VR glasses and start watching the cartoon. During the procedure, the children's parents and the researcher will present, and the children watch the cartoon through virtual reality glasses. After the procedure, the virtual reality glasses will removed, and ten minutes after the procedure will completed, the CFS and the CAS-S will apply as a post-test. Receives: Behavioral: virtual reality glasses used during tooth extraction and extirpation treatment |
| Control | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Means
Anxiety score will be measured with the Child Fear and Anxiety Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's anxiety increases. In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety. Getting a low score from the scale will indicate that their anxiety about the procedure is low.
Measured: 1-4 Weeks
Fear Means
Fear score will be measured with the Children's fear and anxiety scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's fear increases. In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high. A low score on the scale will indicate that fears about the procedure are low.
Measured: 1-4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety and FearStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The population will consist of children between the ages of 7-10 who presented to the pediatric dental clinic of an oral and dental health center Turkey. The sample size of the study was calculated as GPOWER 3.1 statistical analysis software, based on a significance level of 0.05, a power value of 80%, and an effect size of 0.15 (medium effect size). Considering 10% attrition, it will plan to sample a total of 80 children, including 40 in the experimental group and 40 in the control group. Eventually, a total of 120 children, 60 in the experimental group and 60 in the control group,will include in the study to reveal the relationship between the variables more clearly.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murat Bektaş
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Bektaş, Dokuz Eylul University
- Investigators
- Dilek Demir, PhD, Principal investigator, Hakkari University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315816
- Sponsor's protocol ID
- DokuzEU-1
- Status last verified
- Mar 2025
- First submitted
- 29 Dec 2023
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: There is a plan to make IPD and related data dictionaries available. The data will be shared anonymously if the justification is deemed appropriate.
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Virtual Reality Glasses Used During Tooth Extraction and Extirpation Treatment Under Local Anesthesia on Anxiety and Fear in 7-10 Years Old Children
- ClinicalTrials.gov ID
- NCT06315816
- Acronym / sponsor ID
- DokuzEU-1
- Conditions
- Anxiety and Fear, Tooth Disease
- Keywords
- Tooth extraction, Extirpation, Child, Anxiety, fear, Nursing, virtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Murat BektaşUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 18 Mar 2024 (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.
This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.
Detailed description
Aims and Objectives: Virtual reality glasses can be used as a distraction method in dental practices for children. This study carriy out to evaluate the effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in children aged 7-10 years.
Design: A randomized controlled experimental study design will use. Methods: The sample of the study consisted of 120 seven to ten-year-old children, including 60 in the experimental group and 60 in the control group, who will receive tooth extraction and extirpation treatment in the pediatric dental clinic of an oral and dental health center. Data collection tools included a Child and Family Information Form, the Children's Fear Scale, and the Child Anxiety Scale-State. During the procedure, the children in the experimental group will watch a video that they chose through virtual reality glasses. No intervention will apply to the control group. Data will analyz using the Chi-square test, t-test, Shapiro-Wilk, mean, and percentage distributions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The population will consist of children between the ages of 7-10 who presented to the pediatric dental clinic of an oral and dental health center Turkey. The sample size of the study was calculated as GPOWER 3.1 statistical analysis software, based on a significance level of 0.05, a power value of 80%, and an effect size of 0.15 (medium effect size). Considering 10% attrition, it will plan to sample a total of 80 children, including 40 in the experimental group and 40 in the control group. Eventually, a total of 120 children, 60 in the experimental group and 60 in the control group,will include in the study to reveal the relationship between the variables more clearly.
| Arm | Type | Receives |
|---|---|---|
| Experimantal | Experimental | Behavioral: virtual reality glasses used during tooth extraction and extirpation treatmentThe children will ask to choose a three-dimensional cartoon from the list to watch during the procedure, it will run, the mobile phone will placed into the virtual reality glasses, and the children wear the VR glasses and start watching the cartoon. During the procedure, the children's parents and the researcher will present, and the children watch the cartoon through virtual reality glasses. After the procedure, the virtual reality glasses will removed, and ten minutes after the procedure will completed, the CFS and the CAS-S will apply as a post-test. |
| Control | No intervention | –No intervention |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children who will between the ages of 7-10,
- Children who have Tooth Extraction
- Children who have Extirpation Treatment
- Have no cognitive development problems,
Key exclusion criteria (3 listed)
- Children who will not want to participate in the study,
- Leave the research during the study,
- Have an audio-visual disorder that could prevent the use of virtual glasses.
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 |
|---|---|---|
| virtual reality glasses used during tooth extraction and extirpation treatmentThe effect of virtual reality glasses used during tooth extraction and extirpation treatment under local anesthesia on anxiety and fear in 7-10 years old children | Behavioural | Experimantal |
Primary outcome
Anxiety Means
Time frame: 1-4 Weeks
Anxiety score will be measured with the Child Fear and Anxiety Scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's anxiety increases. In this study, if children get high scores from the anxiety section of the scale, it will be determined that they have high procedural anxiety. Getting a low score from the scale will indicate that their anxiety about the procedure is low.
Fear Means
Time frame: 1-4 Weeks
Fear score will be measured with the Children's fear and anxiety scale. The lowest score from the scale can be 0 and the highest score can be 10. As the score obtained from the scale increases, the child's fear increases. In this study, if children score high on the fear section of the scale, it will be determined that their fear of the procedure is high. A low score on the scale will indicate that fears about the procedure are low.
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 21 Mar 2025.
- Individual participant dataSharing planned: Yes. There is a plan to make IPD and related data dictionaries available. The data will be shared anonymously if the justification is deemed appropriate.
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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.
Dilek Demir, PhD principal investigator
Hakkari University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing virtual reality glasses used during tooth extraction and extirpation treatment in people with Anxiety and Fear and Tooth Disease, run by Murat Bektaş at 2 sites in Turkey (Türkiye).
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 4 inclusion and 3 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 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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?
Anxiety Means (time frame: 1-4 Weeks). The study lists 2 primary outcomes in all. 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 21 Mar 2025.