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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

Tracking Information
First Submitted Date  ICMJE March 14, 2017
First Posted Date  ICMJE March 31, 2017
Last Update Posted Date March 31, 2017
Estimated Study Start Date  ICMJE April 2017
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
  • 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)
  • 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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2017)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: March 27, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia
Official Title  ICMJE The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Dental Phobia
Intervention  ICMJE
  • Behavioral: Behavior Therapy
    Virtual Reality and Video based Exposure Therapy
  • Other: Health Education
    Video based health education covering common myths and false believes about dental surgeries
Study Arms  ICMJE
  • Experimental: VR-Video-Exposure
    Intervention: Behavioral: Behavior Therapy
  • Active Comparator: Education-Video-
    Intervention: Other: Health Education
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: March 27, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2018
Estimated Primary Completion Date December 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03098134
Other Study ID Numbers  ICMJE VR-DENT-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dirk Adolph, Ruhr University of Bochum
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE
  • Ruhr University of Bochum (Dr. Andre Wannemüller)
  • Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren)
  • Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)
Investigators  ICMJE Not Provided
PRS Account Ruhr University of Bochum
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP