Dental AnxietyNCT07375056
Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Anxiety in Children
A study testing Intervention 1: Therapeutic Play Group and Intervention 2: Virtual Reality Glasses Group in people with Dental Anxiety and Pain, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Background: A child's first dental experience plays a crucial role in treatment success and in fostering cooperation during future visits. In pediatric dentistry, various non-pharmacological approaches have been implemented to prepare children for dental procedures. Read more about this study
- Who is it for?
- Ages 6 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Anxiety, Pain
- What is being tested?
- Intervention 1: Therapeutic Play Group and Intervention 2: Virtual Reality Glasses Group
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 May 2023to 30 Jul 2023
- 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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 6 to 9 years
- Attending their first dental visit
- Participation voluntarily approved by both the child and the parent or legal guardian
Who cannot join
- Presence of acute dental pain
- Presence of systemic health problems
- Allergy to the modeling compound used in the playset
- Any visual or auditory impairment that could interfere with the use of virtual reality glasses
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry, Erzurum, Turkey
Erzurum, Türkiye, 34000
About this study
Official title: The Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Dental Anxiety Before Local Anesthesia in Children: A Randomized Controlled Trial
Background: A child's first dental experience plays a crucial role in treatment success and in fostering cooperation during future visits. In pediatric dentistry, various non-pharmacological approaches have been implemented to prepare children for dental procedures. This study aims to evaluate the effects of two such approaches-therapeutic play and virtual reality glasses-designed to familiarize children with dental instruments, on pain perception and dental anxiety.
Methods: A total of 66 healthy children aged 6-9 years attending their first dental visit at the Pediatric Dentistry Clinic of Ataturk University will be included. Participants will be randomly assigned into three groups: one group will receive therapeutic play before local anesthesia; the second group will use virtual reality glasses before local anesthesia; and the control group will receive local anesthesia without any preparatory intervention. Dental anxiety and pain will be assessed using the Modified Children's Dental Anxiety Scale (MCDAS), the Wong-Baker FACES Pain Rating Scale (WBS), and the FLACC scale. Physiological parameters including heart rate and oxygen saturation will be recorded before and after anesthesia.
Read the detailed description
Children often experience dental anxiety during their first dental visit, particularly before local anesthesia. Non-pharmacological approaches such as therapeutic play and virtual reality distraction may help reduce anxiety and pain perception. This randomized controlled trial compared the effectiveness of therapeutic play and virtual reality glasses with routine care in reducing dental anxiety and pain in children aged 6-9 years. Anxiety was assessed using the Modified Children's Dental Anxiety Scale, pain was evaluated using the Wong-Baker FACES Pain Rating Scale and FLACC scale, and physiological parameters were recorded.
- Conditions
- Dental Anxiety, Pain
- Being tested
- Intervention 1: Therapeutic Play Group, Intervention 2: Virtual Reality Glasses Group, control group
- Keywords
- Therapeutic play, Virtual reality glasses, Local anesthesia, Pediatric dentistry
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention 1: Therapeutic Play GroupDevice
Therapeutic play intervention before local anesthesia
Intervention 2: Virtual Reality Glasses GroupBehavioural
Use of virtual reality glasses before local anesthesia
control groupOther
Routine local anesthesia without preparatory intervention
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: Therapeutic Play Group | Active comparator | Therapeutic play intervention before local anesthesia Receives: Device: Intervention 1: Therapeutic Play Group |
| Arm 2: Virtual Reality Glasses Group | Active comparator | Use of virtual reality glasses before local anesthesia Receives: Behavioral: Intervention 2: Virtual Reality Glasses Group |
| Arm 3: Control Group | Active comparator | Routine local anesthesia without preparatory intervention Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)
Dental anxiety assessed using the Modified Child Dental Anxiety Scale (MCDAS), a validated questionnaire consisting of 8 items. Total scores range from 8 to 40, with higher scores indicating higher dental anxiety.
Measured: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain score measured by the Wong-Baker FACES Pain Rating Scale
Pain intensity assessed using the Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Measured: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain score measured by the FLACC scale
Pain intensity assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Measured: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Secondary outcomes (2)
Heart Rate (beats per minute)
Heart rate measured using a pulse oximeter
Measured: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Oxygen Saturation (SpO₂)
Oxygen saturation (SpO₂, %) measured using a pulse oximeter.
Measured: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2026
- Study start2 May 2023
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Ataturk 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehpare Yener, Ataturk University
- Investigators
- Mehpare yener, Principal investigator, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07375056
- Sponsor's protocol ID
- AU-ETHICS-2023-03-07
- Status last verified
- Jan 2026
- First submitted
- 29 Dec 2025
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rajeswari SR, Chandrasekhar R, Vinay C, Uloopi KS, RojaRamya KS, Ramesh MV. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):419-422. doi: 10.5005/jp-journals-10005-1661.
PubMed 32440048
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Therapeutic Play and Virtual Reality Glasses on Pain and Dental Anxiety Before Local Anesthesia in Children: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07375056
- Acronym / sponsor ID
- AU-ETHICS-2023-03-07
- Conditions
- Dental Anxiety, Pain
- Keywords
- Therapeutic play, Virtual reality glasses, Local anesthesia, Pediatric dentistry
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 2 May 2023 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 29 Jan 2026 (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.
Background: A child's first dental experience plays a crucial role in treatment success and in fostering cooperation during future visits. In pediatric dentistry, various non-pharmacological approaches have been implemented to prepare children for dental procedures. This study aims to evaluate the effects of two such approaches-therapeutic play and virtual reality glasses-designed to familiarize children with dental instruments, on pain perception and dental anxiety.
Methods: A total of 66 healthy children aged 6-9 years attending their first dental visit at the Pediatric Dentistry Clinic of Ataturk University will be included. Participants will be randomly assigned into three groups: one group will receive therapeutic play before local anesthesia; the second group will use virtual reality glasses before local anesthesia; and the control group will receive local anesthesia without any preparatory intervention. Dental anxiety and pain will be assessed using the Modified Children's Dental Anxiety Scale (MCDAS), the Wong-Baker FACES Pain Rating Scale (WBS), and the FLACC scale. Physiological parameters including heart rate and oxygen saturation will be recorded before and after anesthesia.
Detailed description
Children often experience dental anxiety during their first dental visit, particularly before local anesthesia. Non-pharmacological approaches such as therapeutic play and virtual reality distraction may help reduce anxiety and pain perception. This randomized controlled trial compared the effectiveness of therapeutic play and virtual reality glasses with routine care in reducing dental anxiety and pain in children aged 6-9 years. Anxiety was assessed using the Modified Children's Dental Anxiety Scale, pain was evaluated using the Wong-Baker FACES Pain Rating Scale and FLACC scale, and physiological parameters were recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Therapeutic Play Group | Active comparator | Device: Intervention 1: Therapeutic Play GroupTherapeutic play intervention before local anesthesia |
| Arm 2: Virtual Reality Glasses Group | Active comparator | Behavioral: Intervention 2: Virtual Reality Glasses GroupUse of virtual reality glasses before local anesthesia |
| Arm 3: Control Group | Active comparator | Other: control groupRoutine local anesthesia without preparatory intervention |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children aged 6 to 9 years
- Attending their first dental visit
- Participation voluntarily approved by both the child and the parent or legal guardian
Key exclusion criteria (4 listed)
- Presence of acute dental pain
- Presence of systemic health problems
- Allergy to the modeling compound used in the playset
- Any visual or auditory impairment that could interfere with the use of virtual reality 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 |
|---|---|---|
| Intervention 1: Therapeutic Play GroupTherapeutic play intervention before local anesthesia | Device | Arm 1: Therapeutic Play Group |
| Intervention 2: Virtual Reality Glasses GroupUse of virtual reality glasses before local anesthesia | Behavioural | Arm 2: Virtual Reality Glasses Group |
| control groupRoutine local anesthesia without preparatory intervention | Other | Arm 3: Control Group |
Primary outcome
Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS)
Time frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Dental anxiety assessed using the Modified Child Dental Anxiety Scale (MCDAS), a validated questionnaire consisting of 8 items. Total scores range from 8 to 40, with higher scores indicating higher dental anxiety.
Pain score measured by the Wong-Baker FACES Pain Rating Scale
Time frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the Wong-Baker FACES Pain Rating Scale, with scores ranging from 0 to 10, where higher scores indicate more severe pain.
Pain score measured by the FLACC scale
Time frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Pain intensity assessed using the FLACC scale (Face, Legs, Activity, Cry, Consolability), with scores ranging from 0 to 10, where higher scores indicate more severe pain.
2 secondary outcomes
Heart Rate (beats per minute)
Time frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
Oxygen Saturation (SpO₂)
Time frame: Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection
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 29 Jan 2026.
- Background: PubMed 32440048Rajeswari SR, Chandrasekhar R, Vinay C, Uloopi KS, RojaRamya KS, Ramesh MV. Effectiveness of Cognitive Behavioral Play Therapy and Audiovisual Distraction for Management of Preoperative Anxiety in Children. Int J Clin Pediatr Dent. 2019 Sep-Oct;12(5):419-422. doi: 10.5005/jp-journals-10005-1661.
- Individual participant dataSharing planned: No
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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.
Mehpare yener principal investigator
Ataturk University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention 1: Therapeutic Play Group and Intervention 2: Virtual Reality Glasses Group in people with Dental Anxiety and Pain, run by Ataturk University at 1 site 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 3 inclusion and 4 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 29 Jan 2026. 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 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?
Dental anxiety score measured by the Modified Child Dental Anxiety Scale (MCDAS) (time frame: Baseline (before intervention), Pre-anesthesia (before local anesthesia), Immediately after local anesthesia injection). The study lists 3 primary outcomes in all. 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 NCT07375056, which also lists 1 linked publication.
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 29 Jan 2026.