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CompletedNCT01933191Updated Feb 9, 2015

Exercise Treatment of Dental Anxiety

An interventional study of Aerobic treadmill exercise and placebo exercise in Dental Anxiety, sponsored by Charite University, Berlin, Germany. Completed at 1 site in Germany. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2015-02-09.

Sponsored by Charite University, Berlin, Germany · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the 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

02

Conditions studied

  • Dental Anxiety

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Keywords

  • Dental Anxiety, Physical Activity, Dental Phobia
  • Cortisol, Amylase
03

In context

Anxiety Disorders

4,868 studies on the registry are indexed under Anxiety Disorders; 1,390 are open to participants now.

This study's enrollment of 30 is below the median of 80 across 4,174 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Charite University, Berlin, Germany is the lead sponsor of 836 studies on the registry; 129 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    physical acticity

    Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)

    Behavioral: Aerobic treadmill exercise · Behavioral: placebo exercise

  • Placebo comparator
    placebo exercise

    Aerobic treadmill exercise (30 minutes, 20% VO2max)

    Behavioral: Aerobic treadmill exercise · Behavioral: placebo exercise

Interventions

  • BehavioralAerobic 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).

    Also known as: physical activity VO2-70%

  • Behavioralplacebo 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).

    Also known as: physical activity VO2-20%

06

What researchers measure

Primary outcomes

  1. Change from Baseline in VAS - visual analog scale

    Change in the visual analogue scale (VAS) for anxiety

    Time frame: Baseline and one hour after dental intervention

Secondary outcomes

  1. Change from Baseline in cortisol level

    Cortisol is one of the main hormones released by the body as a reaction to stress.

    Time frame: Baseline and one hour

  2. Change from Baseline in alpha-Amylase

    Salivary alpha-Amylase

    Time frame: Baseline and one hour after dental intervention

07

Study locations

1 site
  • Department of Psychiatry and Psychotherapy Campus Charité Mitte
    Berlin, 10117, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01933191
Lead sponsor
Charite University, Berlin, Germany
Responsible party
Prof. Dr. Andreas Ströhle (Prof. Dr., Charite University, Berlin, Germany) — Principal investigator
First posted
Sep 2, 2013
Start date
Aug 2011
Primary completion
Sep 2013
Completion
Oct 2013
Last update
Feb 9, 2015

Study contacts

Andreas Ströhle, Prof. Dr.
principal investigator · Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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