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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03098134
Recruitment Status : Unknown
Verified March 2017 by Dirk Adolph, Ruhr University of Bochum.
Recruitment status was:  Not yet recruiting
First Posted : March 31, 2017
Last Update Posted : March 31, 2017
Sponsor:
Collaborators:
Ruhr University of Bochum (Dr. Andre Wannemüller)
Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren)
Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)
Information provided by (Responsible Party):
Dirk Adolph, Ruhr University of Bochum

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.

Condition or disease Intervention/treatment Phase
Dental Phobia Behavioral: Behavior Therapy Other: Health Education Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial
Estimated Study Start Date : April 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : May 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

Arm Intervention/treatment
Experimental: VR-Video-Exposure Behavioral: Behavior Therapy
Virtual Reality and Video based Exposure Therapy

Active Comparator: Education-Video- Other: Health Education
Video based health education covering common myths and false believes about dental surgeries




Primary Outcome Measures :
  1. Change in Subjective Dental Anxiety [ Time Frame: 4 month ]
    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)

  2. Change in Dysfunctional Dental Cognitions [ Time Frame: 4 months ]
    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 :
  1. Change in Psychophysiological defensive reactivity [ Time Frame: 4 weeks ]
    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)


Other Outcome Measures:
  1. Change in dental avoidance behavior [ Time Frame: within three month after the therapy took place ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03098134


Contacts
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Contact: Dirk Adolph, Dr. +492343223177 dirk.adolph@rub.de
Contact: Andre Wannemueller, Dr. +492343223106 andre.wannemueller@rub.de

Sponsors and Collaborators
Ruhr University of Bochum
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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Responsible Party: Dirk Adolph, Head of Clinical Psychophysiology Lab, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT03098134    
Other Study ID Numbers: VR-DENT-1
First Posted: March 31, 2017    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phobic Disorders
Anxiety Disorders
Mental Disorders