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The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia (VR-DENT)

Primary Purpose

Dental Phobia

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Behavior Therapy
Health Education
Sponsored by
Ruhr University of Bochum
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Phobia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- diagnosed Specific Dental Phobia

Exclusion Criteria:

  • Schizophrenia or other Psychotic Illnesses
  • Bipolar Disorder
  • Chronic Headache
  • other neurological disorders such as epilepsy
  • Hearing problems

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    VR-Video-Exposure

    Education-Video-

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in Subjective Dental Anxiety
    Assessed at time 0 (at inclusion) 1 (pre therapy, two weeks after inclusion), 2(post therapy, 2 weeks after time 1) and at follow up (4 month after time 0) with Dental Anxiety Scale (DAS, 4-item scale, range 4-20)
    Change in Dysfunctional Dental Cognitions
    Assessed with Dental Cognition Questionnaire (DCQ, 38 dichotomous items, range 0-38) Assessed at time 0 (at inclusion), time 1 (pre therapy, two weeks after time 0), time 2 (post therapy, 2 weeks after time 1) and at follow up (4 month after time 0)

    Secondary Outcome Measures

    Change in Psychophysiological defensive reactivity
    Participants will take part in a passive Picture viewing paradigm. They will be exposed to dental anxiety related Pictures, generally negative pictures, neutral, and positive pictures. Outcome measures will be withdrawal-related motor responding (assessed with the startle-reflex), as well as heart frequency change towards the pictures, The task will be applied at inclusion (time 0) and post therapy (4 weeks after inclusion)

    Full Information

    First Posted
    March 14, 2017
    Last Updated
    March 27, 2017
    Sponsor
    Ruhr University of Bochum
    Collaborators
    Ruhr University of Bochum (Dr. Andre Wannemüller), Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren), Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03098134
    Brief Title
    The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia
    Acronym
    VR-DENT
    Official Title
    The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2017 (Anticipated)
    Primary Completion Date
    December 31, 2017 (Anticipated)
    Study Completion Date
    May 1, 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Ruhr University of Bochum
    Collaborators
    Ruhr University of Bochum (Dr. Andre Wannemüller), Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren), Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dental Phobia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    VR-Video-Exposure
    Arm Type
    Experimental
    Arm Title
    Education-Video-
    Arm Type
    Active Comparator
    Intervention Type
    Behavioral
    Intervention Name(s)
    Behavior Therapy
    Intervention Description
    Virtual Reality and Video based Exposure Therapy
    Intervention Type
    Other
    Intervention Name(s)
    Health Education
    Intervention Description
    Video based health education covering common myths and false believes about dental surgeries
    Primary Outcome Measure Information:
    Title
    Change in Subjective Dental Anxiety
    Description
    Assessed at time 0 (at inclusion) 1 (pre therapy, two weeks after inclusion), 2(post therapy, 2 weeks after time 1) and at follow up (4 month after time 0) with Dental Anxiety Scale (DAS, 4-item scale, range 4-20)
    Time Frame
    4 month
    Title
    Change in Dysfunctional Dental Cognitions
    Description
    Assessed with Dental Cognition Questionnaire (DCQ, 38 dichotomous items, range 0-38) Assessed at time 0 (at inclusion), time 1 (pre therapy, two weeks after time 0), time 2 (post therapy, 2 weeks after time 1) and at follow up (4 month after time 0)
    Time Frame
    4 months
    Secondary Outcome Measure Information:
    Title
    Change in Psychophysiological defensive reactivity
    Description
    Participants will take part in a passive Picture viewing paradigm. They will be exposed to dental anxiety related Pictures, generally negative pictures, neutral, and positive pictures. Outcome measures will be withdrawal-related motor responding (assessed with the startle-reflex), as well as heart frequency change towards the pictures, The task will be applied at inclusion (time 0) and post therapy (4 weeks after inclusion)
    Time Frame
    4 weeks
    Other Pre-specified Outcome Measures:
    Title
    Change in dental avoidance behavior
    Description
    Each participant will be asked to arrange an appointment in a cooperating dental Hospital. It will be assessed (1) if participant makes a - (2) and attends to - first appointment (3) if participant tolerates oral inspection and dental treatment (4) how many further appointments will be made
    Time Frame
    within three month after the therapy took place

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - diagnosed Specific Dental Phobia Exclusion Criteria: Schizophrenia or other Psychotic Illnesses Bipolar Disorder Chronic Headache other neurological disorders such as epilepsy Hearing problems
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dirk Adolph, Dr.
    Phone
    +492343223177
    Email
    dirk.adolph@rub.de
    First Name & Middle Initial & Last Name or Official Title & Degree
    Andre Wannemueller, Dr.
    Phone
    +492343223106
    Email
    andre.wannemueller@rub.de

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia

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