Dental Anxiety During Restorative Dental Treatment
DADRDT
Evaluation of the Effect of Hypnotherapy, Virtual Reality and Mindfulness Applications on Dental Anxiety During Restorative Dental Treatment
1 other identifier
interventional
80
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 29, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 29, 2024
CompletedFirst Submitted
Initial submission to the registry
October 4, 2024
CompletedFirst Posted
Study publicly available on registry
October 8, 2024
CompletedOctober 8, 2024
October 1, 2024
1 year
October 4, 2024
October 4, 2024
Conditions
Keywords
Outcome Measures
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'.
5 minutes before procedure and 5 minutes after procedure
Secondary Outcomes (2)
Dental Fear Survey
5 minutes before procedure and 5 minutes after procedure
The Visual Analogue Scale
5 minutes after procedure
Study Arms (4)
Control
PLACEBO COMPARATORhypnotherapy
ACTIVE COMPARATORvirtual reality
ACTIVE COMPARATORmindfulness-based meditation
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ataturk University Faculty of Dentistry
Erzurum, Yakutiye, 25100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 31003184RESULTPrado 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.
PMID: 30908775RESULT
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research assistant dentist
Study Record Dates
First Submitted
October 4, 2024
First Posted
October 8, 2024
Study Start
February 26, 2023
Primary Completion
February 29, 2024
Study Completion
May 29, 2024
Last Updated
October 8, 2024
Record last verified: 2024-10