Exercise Treatment of Dental Anxiety

N/ACompletedNCT01933191

Charite University, Berlin, Germany30 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Dental Anxiety

Interventions

Aerobic treadmill exerciseBEHAVIORAL

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).

placebo exerciseBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Psychiatry and Psychotherapy Campus Charité Mitte

Berlin, Germany

Outcomes

Primary Outcomes

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

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

Change from Baseline in alpha-Amylase

Salivary alpha-Amylase

Time frame: Baseline and one hour after dental intervention

Data from ClinicalTrials.gov

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