Exercise Treatment of Dental Anxiety

Not Applicable

Completed

• Conditions: Dental Anxiety
• Interventions: Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise

• Registration Number: NCT01933191
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

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

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-07-26
• Study First Submitted QC: 2013-08-30
• Primary Completion: 2013-09
• Study First Posted: 2013-09-02
• Study Completion: 2013-10
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-06
• Last Update Posted: 2015-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
physical acticity	placebo exercise	Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
placebo exercise	Aerobic treadmill exercise	Aerobic treadmill exercise (30 minutes, 20% VO2max)
physical acticity	Aerobic treadmill exercise	Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
placebo exercise	placebo exercise	Aerobic treadmill exercise (30 minutes, 20% VO2max)

Primary Outcome Measures

Name	Time	Method
Change from Baseline in VAS - visual analog scale	Baseline and one hour after dental intervention	Change in the visual analogue scale (VAS) for anxiety

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in cortisol level	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	Baseline and one hour after dental intervention	Salivary alpha-Amylase

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy Campus Charité Mitte; 🇩🇪 Berlin, Germany