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CompletedNCT06629870DADRDTUpdated Oct 8, 2024

Dental Anxiety During Restorative Dental Treatment

An interventional study of virtual reality and control group in Hypnotherapy, Virtual Reality and Mindfulness, sponsored by Ataturk University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-08.

Sponsored by Ataturk University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 7 months after the study started (first participant enrolled Feb 2023, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

This study aims to evaluate the effects of hypnotherapy, virtual reality distraction and mindfulness-based meditation practices on dental anxiety during restorative dental treatment.

02

Conditions studied

  • Hypnotherapy
  • Virtual Reality
  • Mindfulness

Keywords

  • Dental anxiety, hypnotherapy, virtual reality glasses application, mindfulness-based meditation practice
03

In context

Lead sponsor

Ataturk University is the lead sponsor of 456 studies on the registry; 124 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Placebo comparator
    Control

    Other: control group

  • Active comparator
    hypnotherapy

    Other: hypnotherapy

  • Active comparator
    virtual reality

    Device: virtual reality

  • Active comparator
    mindfulness-based meditation

    Other: mindfulness

Interventions

  • Devicevirtual reality

    patients who received distraction using virtual reality glasses

  • Othercontrol group

    no any anxiety-reducing application

  • Otherhypnotherapy

    patients receiving hypnotherapy

  • Othermindfulness

    patients who underwent mindfulness-based meditation

06

What researchers measure

Primary outcomes

  1. 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'.

    Time frame: 5 minutes before procedure and 5 minutes after procedure

Secondary outcomes

  1. Dental Fear Survey

    The items in this questionnaire refer to various situations, feelings, and reactions related to dental work

    Time frame: 5 minutes before procedure and 5 minutes after procedure

  2. 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.

    Time frame: 5 minutes after procedure

07

Study locations

1 site
  • Ataturk University Faculty of Dentistry
    Erzurum, Yakutiye 25100, Turkey (Türkiye)
08

References and documents

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 31003184 ↗
  • Prado 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 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2023 to primary completion in Feb 2024, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2024
First posted
Oct 8, 2024
StartActual
Feb 26, 2023
Primary completionActual
Feb 29, 2024
CompletionActual
May 29, 2024
Last update
Oct 8, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 8, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06629870
Lead sponsor
Ataturk University
Responsible party
Fatih Alkan (Research assistant dentist, Ataturk University) — Principal investigator
First posted
Oct 8, 2024
Start date
Feb 26, 2023
Primary completion
Feb 29, 2024
Completion
May 29, 2024
Last update
Oct 8, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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