HypnotherapyDADRDTNCT06629870
Dental Anxiety During Restorative Dental Treatment
A study testing virtual reality, hypnotherapy and mindfulness in people with Hypnotherapy and Virtual Reality, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
Anxiety refers to behavioural disorders associated with excessive fear and anxiety. Dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. This may cause patients to avoid dental treatments and may adversely affect oral health. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypnotherapy, Virtual Reality, Mindfulness
- What is being tested?
- virtual reality, hypnotherapy and mindfulness
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2023to 29 May 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A modified dental anxiety score of 20 and above
- A dental fear scale score of 59 and above
- D2 level caries according to radiographic caries classification system,
- Systemically healthy patients
Who cannot join
- Balance disorders such as nystagmus and vertigo,
- Pregnant woman
- Claustrophobia
- Physical or mental disability
- Not knowing how to read and write
- Psychological disturbance
- Taking antidepressants or anxiolytics
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University Faculty of Dentistry
Erzurum, Yakutiye, 25100
About this study
Official title: Evaluation of the Effect of Hypnotherapy, Virtual Reality and Mindfulness Applications on Dental Anxiety During Restorative Dental Treatment
Anxiety refers to behavioural disorders associated with excessive fear and anxiety. Dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. This may cause patients to avoid dental treatments and may adversely affect oral health.
This study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.
- Conditions
- Hypnotherapy, Virtual Reality, Mindfulness
- Being tested
- virtual reality, control group, hypnotherapy, mindfulness
- Keywords
- Dental anxiety, hypnotherapy, virtual reality glasses application, mindfulness-based meditation practice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual realityDevice
patients who received distraction using virtual reality glasses
control groupOther
no any anxiety-reducing application
hypnotherapyOther
patients receiving hypnotherapy
mindfulnessOther
patients who underwent mindfulness-based meditation
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Not described Receives: Other: control group |
| hypnotherapy | Active comparator | Not described Receives: Other: hypnotherapy |
| virtual reality | Active comparator | Not described Receives: Device: virtual reality |
| mindfulness-based meditation | Active comparator | Not described Receives: Other: mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Dental Anxiety Scale
The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'.
Measured: 5 minutes before procedure and 5 minutes after procedure
Secondary outcomes (2)
Dental Fear Survey
The items in this questionnaire refer to various situations, feelings, and reactions related to dental work
Measured: 5 minutes before procedure and 5 minutes after procedure
The Visual Analogue Scale
The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.
Measured: 5 minutes after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start26 Feb 2023
- Primary completion29 Feb 2024
- Study completion29 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypnotherapyStudies 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatih Alkan, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06629870
- Sponsor's protocol ID
- ATAUNIRESTORATIVE1
- Acronym
- DADRDT
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 8 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Joda T, Gallucci GO, Wismeijer D, Zitzmann NU. Augmented and virtual reality in dental medicine: A systematic review. Comput Biol Med. 2019 May;108:93-100. doi: 10.1016/j.compbiomed.2019.03.012. Epub 2019 Mar 15.
PubMed 31003184Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
PubMed 30908775
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hypnotherapy, Virtual Reality and Mindfulness Applications on Dental Anxiety During Restorative Dental Treatment
- ClinicalTrials.gov ID
- NCT06629870
- Acronym / sponsor ID
- DADRDT / ATAUNIRESTORATIVE1
- Conditions
- Hypnotherapy, Virtual Reality, Mindfulness
- Keywords
- Dental anxiety, hypnotherapy, virtual reality glasses application, mindfulness-based meditation practice
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 26 Feb 2023 (actual)
- Primary completion
- 29 Feb 2024 (actual)
- Study completion
- 29 May 2024 (actual)
- First posted
- 8 Oct 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.
Anxiety refers to behavioural disorders associated with excessive fear and anxiety. Dental anxiety refers to excessive fear and anxiety at the thought of going to the dentist. This may cause patients to avoid dental treatments and may adversely affect oral health.
This study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: control group |
| hypnotherapy | Active comparator | Other: hypnotherapy |
| virtual reality | Active comparator | Device: virtual reality |
| mindfulness-based meditation | Active comparator | Other: mindfulness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- A modified dental anxiety score of 20 and above
- A dental fear scale score of 59 and above
- D2 level caries according to radiographic caries classification system,
- Systemically healthy patients
Key exclusion criteria (7 listed)
- Balance disorders such as nystagmus and vertigo,
- Pregnant woman
- Claustrophobia
- Physical or mental disability
- Not knowing how to read and write
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 realitypatients who received distraction using virtual reality glasses | Device | virtual reality |
| control groupno any anxiety-reducing application | Other | Control |
| hypnotherapypatients receiving hypnotherapy | Other | hypnotherapy |
| mindfulnesspatients who underwent mindfulness-based meditation | Other | mindfulness-based meditation |
Primary outcome
Modified Dental Anxiety Scale
Time frame: 5 minutes before procedure and 5 minutes after procedure
The Modified Dental Anxiety Scale (MDAS) consists of 5 questions each with a 5 category rating scale, ranging from 'not anxious' to 'extremely anxious'.
2 secondary outcomes
Dental Fear Survey
Time frame: 5 minutes before procedure and 5 minutes after procedure
The Visual Analogue Scale
Time frame: 5 minutes after procedure
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 8 Oct 2024.
- Results publication: PubMed 31003184Joda T, Gallucci GO, Wismeijer D, Zitzmann NU. Augmented and virtual reality in dental medicine: A systematic review. Comput Biol Med. 2019 May;108:93-100. doi: 10.1016/j.compbiomed.2019.03.012. Epub 2019 Mar 15.
- Results publication: PubMed 30908775Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.
- 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.
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?
A study testing virtual reality, hypnotherapy and mindfulness in people with Hypnotherapy and Virtual Reality, 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 4 inclusion and 7 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 8 Oct 2024. 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. Some participants in this study may receive a placebo. 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?
Modified Dental Anxiety Scale (time frame: 5 minutes before procedure and 5 minutes after procedure). 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 NCT06629870, which also lists 2 linked publications.
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 8 Oct 2024.