Dental Anxiety During Restorative Dental Treatment (DADRDT)

October 4, 2024 updated by: Fatih Alkan, Ataturk University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Yakutiye
      • Erzurum, Yakutiye, Turkey, 25100
        • Atatürk University Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Control
Other: control group
no any anxiety-reducing application
Active Comparator: hypnotherapy
Other: hypnotherapy
patients receiving hypnotherapy
Active Comparator: virtual reality
Device: virtual reality
patients who received distraction using virtual reality glasses
Active Comparator: mindfulness-based meditation
Other: mindfulness
patients who underwent mindfulness-based meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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'.
5 minutes before procedure and 5 minutes after procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dental Fear Survey
Time Frame: 5 minutes before procedure and 5 minutes after procedure
The items in this questionnaire refer to various situations, feelings, and reactions related to dental work
5 minutes before procedure and 5 minutes after procedure
The Visual Analogue Scale
Time Frame: 5 minutes after procedure
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.
5 minutes after procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ataturk University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2023

Primary Completion (Actual)

February 29, 2024

Study Completion (Actual)

May 29, 2024

Study Registration Dates

First Submitted

October 4, 2024

First Submitted That Met QC Criteria

October 4, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ATAUNIRESTORATIVE1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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