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Exercise Treatment of Dental Anxiety

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01933191
First Posted: September 2, 2013
Last Update Posted: February 9, 2015
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.
Information provided by (Responsible Party):
Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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 Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Change from Baseline in VAS - visual analog scale [ Time Frame: Baseline and one hour after dental intervention ]
    Change in the visual analogue scale (VAS) for anxiety


Secondary Outcome Measures:
  • Change from Baseline in cortisol level [ Time Frame: Baseline and one hour ]
    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 ]
    Salivary alpha-Amylase


Enrollment: 30
Study Start Date: August 2011
Study Completion Date: October 2013
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT01933191


Locations
Germany
Department of Psychiatry and Psychotherapy Campus Charité Mitte
Berlin, Germany, 10117
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

Responsible Party: Prof. Dr. Andreas Ströhle, Prof. Dr., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01933191     History of Changes
Other Study ID Numbers: 221014
First Submitted: July 26, 2013
First Posted: September 2, 2013
Last Update Posted: February 9, 2015
Last Verified: February 2015

Keywords provided by Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany:
Dental Anxiety, Physical Activity, Dental Phobia
Cortisol, Amylase

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders