Dental AnxietyRCTNCT07911475
Evaluation of the Effects of Virtual Reality Applications on Salivary Cortisol Levels and Vital Signs in Adults With Dental Anxiety During Restorative Dental Treatments
An observational study of Dental Anxiety and Music Therapy, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
In this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Dental Anxiety, Music Therapy, Salivary Cortisol
- What is being tested?
- Music Therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 250 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Apr 2024to 10 Jan 2026
- How long will I take part?
- 1 Week
- Phase
- Observational
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: Participants administered to Dokuz Eylul University Restorative Dentistry department for their routine dental treatment.
Who may be able to join
- >= MDAS 13 score
- interproximal carious lesions in mandibular premolars
- systemically healthy participants
- no drug use 18-45 ages
Who cannot join
- unstable systemical diseases
- hearing problems
- eye/vision problems
- greater than 45 years old
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
DEU Restorative Dentistry, Faculty of Dentistry
Izmir, 35340
About this study
Official title: EVALUATION OF THE EFFECTS OF VIRTUAL REALITY APPLICATIONS ON SALIVARY CORTISOL LEVELS AND VITAL SIGNS IN ADULTS WITH DENTAL ANXIETY DURING RESTORATIVE DENTAL TREATMENTS
In this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed.
The aim of this study was to evaluate the effect of a VR-assisted audiovisual intervention on acute physiological stress responses and patient-reported post-treatment feelings in adults with dental anxiety undergoing restorative procedures. MDAS was used only to characterize eligibility at baseline; post-intervention subjective anxiety was not assessed.
- Being tested
- Music Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music TherapyBehavioural
Also called Virtual Reality
In this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed.
| Study group | Role | What they receive |
|---|---|---|
| Group 1- Intervention group | In the intervention group, VR and the headphones for the audiovisual distraction is administered. Physiological measurements and salivary cortisol measurements are done before and after the procedure. Receives: Behavioral: Music Therapy | |
| Group 2- Control group | VR and the headphones are not administered. Only physiological measurements and salivary cortisol measurements are done before and after the procedure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Salivary Cortisol Level
Salivary cortisol concentration was measured in micrograms per deciliter (µg/dL) using saliva samples collected before and after restorative dental treatment. Changes in salivary cortisol levels were calculated as the post-treatment value minus the baseline value to evaluate the physiological stress response associated with virtual reality exposure during dental treatment.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Change in Heart Rate
Heart rate was measured in beats per minute (bpm) using a digital pulse oximeter before and after restorative dental treatment. Changes in heart rate were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Change in Systolic Blood Pressure
Systolic blood pressure was measured in millimeters of mercury (mmHg) using a digital blood pressure monitor before and after restorative dental treatment. Changes in systolic blood pressure were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Change in Diastolic Blood Pressure
Diastolic blood pressure was measured in millimeters of mercury (mmHg) using a digital blood pressure monitor before and after restorative dental treatment. Changes in diastolic blood pressure were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Change in Body Temperature
Body temperature was measured in degrees Celsius (°C) using a digital thermometer before and after restorative dental treatment. Changes in body temperature were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Change in Peripheral Oxygen Saturation (SpO₂)
Peripheral oxygen saturation (SpO₂) was measured as a percentage (%) using a digital pulse oximeter before and after restorative dental treatment. Changes in oxygen saturation were calculated as the post-treatment value minus the baseline value and expressed in percentage points to evaluate physiological responses to virtual reality exposure during the procedure.
Measured: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Baseline Dental Anxiety Level
Baseline dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS), a five-item questionnaire with a total score ranging from 5 to 25. Higher scores indicate greater dental anxiety. The scale was administered before restorative dental treatment to determine participants' baseline dental anxiety levels.
Measured: Baseline (before restorative dental treatment, Day 1).
Secondary outcomes (1)
Patient Satisfaction Following Restorative Dental Treatment
Patient satisfaction with the restorative dental treatment experience was assessed immediately after the procedure using a five-point Likert-type satisfaction scale. Higher scores indicate greater patient satisfaction.
Measured: Immediately after completion of restorative dental treatment (Day 1).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Apr 2024
- Primary completion30 Jul 2025
- Study completion10 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (actual)
- Target duration
- 1 Week
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asli Silkü Oflioğlu, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911475
- Sponsor's protocol ID
- Approval No: 2024/13-11
- Acronym
- RCT
- Status last verified
- Oct 2026
- First submitted
- 20 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION OF THE EFFECTS OF VIRTUAL REALITY APPLICATIONS ON SALIVARY CORTISOL LEVELS AND VITAL SIGNS IN ADULTS WITH DENTAL ANXIETY DURING RESTORATIVE DENTAL TREATMENTS
- ClinicalTrials.gov ID
- NCT07911475
- Acronym / sponsor ID
- RCT / Approval No: 2024/13-11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 20 Apr 2024 (actual)
- Primary completion
- 30 Jul 2025 (actual)
- Study completion
- 10 Jan 2026 (actual)
- First posted
- 2 Nov 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.
In this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed.
The aim of this study was to evaluate the effect of a VR-assisted audiovisual intervention on acute physiological stress responses and patient-reported post-treatment feelings in adults with dental anxiety undergoing restorative procedures. MDAS was used only to characterize eligibility at baseline; post-intervention subjective anxiety was not assessed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Week
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1- Intervention group | – | Behavioral: Music TherapyIn the intervention group, VR and the headphones for the audiovisual distraction is administered. Physiological measurements and salivary cortisol measurements are done before and after the procedure. |
| Group 2- Control group | – | –VR and the headphones are not administered. Only physiological measurements and salivary cortisol measurements are done before and after the procedure. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Participants administered to Dokuz Eylul University Restorative Dentistry department for their routine dental treatment.
Key inclusion criteria (4 listed)
- >= MDAS 13 score
- interproximal carious lesions in mandibular premolars
- systemically healthy participants
- no drug use 18-45 ages
Key exclusion criteria (4 listed)
- unstable systemical diseases
- hearing problems
- eye/vision problems
- greater than 45 years old
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 |
|---|---|---|
| Music TherapyAlso: Virtual RealityIn this study, adults selected using an MDAS score ≥13 received a combined visual and auditory distraction intervention during restorative treatment. Salivary cortisol and vital signs were measured before and after treatment, and patients rated how they felt after treatment; subjective anxiety was not reassessed. | Behavioural | Group 1- Intervention group |
Primary outcome
Change in Salivary Cortisol Level
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Salivary cortisol concentration was measured in micrograms per deciliter (µg/dL) using saliva samples collected before and after restorative dental treatment. Changes in salivary cortisol levels were calculated as the post-treatment value minus the baseline value to evaluate the physiological stress response associated with virtual reality exposure during dental treatment.
Change in Heart Rate
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Heart rate was measured in beats per minute (bpm) using a digital pulse oximeter before and after restorative dental treatment. Changes in heart rate were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Change in Systolic Blood Pressure
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Systolic blood pressure was measured in millimeters of mercury (mmHg) using a digital blood pressure monitor before and after restorative dental treatment. Changes in systolic blood pressure were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Change in Diastolic Blood Pressure
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Diastolic blood pressure was measured in millimeters of mercury (mmHg) using a digital blood pressure monitor before and after restorative dental treatment. Changes in diastolic blood pressure were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Change in Body Temperature
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Body temperature was measured in degrees Celsius (°C) using a digital thermometer before and after restorative dental treatment. Changes in body temperature were calculated as the post-treatment value minus the baseline value to evaluate physiological responses to virtual reality exposure during the procedure.
Change in Peripheral Oxygen Saturation (SpO₂)
Time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)
Peripheral oxygen saturation (SpO₂) was measured as a percentage (%) using a digital pulse oximeter before and after restorative dental treatment. Changes in oxygen saturation were calculated as the post-treatment value minus the baseline value and expressed in percentage points to evaluate physiological responses to virtual reality exposure during the procedure.
Baseline Dental Anxiety Level
Time frame: Baseline (before restorative dental treatment, Day 1).
Baseline dental anxiety was assessed using the Modified Dental Anxiety Scale (MDAS), a five-item questionnaire with a total score ranging from 5 to 25. Higher scores indicate greater dental anxiety. The scale was administered before restorative dental treatment to determine participants' baseline dental anxiety levels.
1 secondary outcome
Patient Satisfaction Following Restorative Dental Treatment
Time frame: Immediately after completion of restorative dental treatment (Day 1).
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 2 Nov 2026.
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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.
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?
An observational study of Dental Anxiety and Music Therapy, run by Dokuz Eylul 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 4 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 2 Nov 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?
Change in Salivary Cortisol Level (time frame: Baseline (immediately before restorative dental treatment) and immediately after completion of the dental procedure (Day 1)). The study lists 7 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 2 Nov 2026.