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Exercise Treatment of Dental Anxiety

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01933191
First received: July 26, 2013
Last updated: August 30, 2013
Last verified: August 2013
  Purpose

A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia.


Condition Intervention
Dental Anxiety
Behavioral: Aerobic treadmill exercise
Behavioral: placebo exercise

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change from Baseline in VAS - visual analog scale [ Time Frame: Baseline and one hour after dental intervention ] [ Designated as safety issue: No ]
    Change in the visual analogue scale (VAS) for anxiety


Secondary Outcome Measures:
  • Change from Baseline in cortisol level [ Time Frame: Baseline and one hour ] [ Designated as safety issue: No ]
    Cortisol is one of the main hormones released by the body as a reaction to stress.

  • Change from Baseline in alpha-Amylase [ Time Frame: Baseline and one hour after dental intervention ] [ Designated as safety issue: No ]
    Salivary alpha-Amylase


Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: physical acticity
Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
Behavioral: Aerobic treadmill exercise
Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
Other Name: physical activity VO2-70%
Behavioral: placebo exercise
placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
Other Name: physical activity VO2-20%
Placebo Comparator: placebo exercise
Aerobic treadmill exercise (30 minutes, 20% VO2max)
Behavioral: Aerobic treadmill exercise
Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
Other Name: physical activity VO2-70%
Behavioral: placebo exercise
placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
Other Name: physical activity VO2-20%

Detailed Description:

The primary objective of the trial is to assess the anxiolytic efficacy of 30 minutes aerobic treadmill exercise versus placebo exercise in subjects experiencing high anxiety prior to a minor dental dental procedure.

Primary efficacy endpoint:

Change in the visual analogue scale (VAS) for anxiety before and after the intervention prior to the elective minor dental procedure

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatients 18 years of age or older
  • A total score of 12 points or more on the Dental Anxiety Scale at screening and baseline evaluations
  • Scheduled appointment for an elective minor dental procedure
  • Informed consent

Exclusion Criteria:

  • Pregnant or lactating women
  • Current diagnosis of any other DSM-IV, with the exception of other phobic disorders, social anxiety disorder or dysthymia
  • Serious medical disorders which put subjects at risk if they have to exercise 30 minutes at 70% VO2max
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01933191

Locations
Germany
Department of Psychiatry and Psychotherapy Campus Charité Mitte Recruiting
Berlin, Germany, 10117
Contact: Andreas Ströhle, Prof. Dr.    +4930 450517034    andreas.stroehle@charite.de   
Contact: Brigitt-Leila v. Lindenberger, M.Sc    +4930450517 273    brigitt-leila.lindenberger@charite.de   
Principal Investigator: Andreas Ströhle, Prof. Dr.         
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Andreas Ströhle, Prof. Dr. Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
  More Information

No publications provided

Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01933191     History of Changes
Other Study ID Numbers: 221014
Study First Received: July 26, 2013
Last Updated: August 30, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
Dental Anxiety, Physical Activity, Dental Phobia
Cortisol, Amylase

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014