Exercise Treatment of Dental Anxiety

A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety

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

Study Overview

• Status: Completed
• Conditions: Dental Anxiety
• Intervention / Treatment: Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: 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 Names: 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 Names: physical activity VO2-20%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in VAS - visual analog scale	Change in the visual analogue scale (VAS) for anxiety	Baseline and one hour after dental intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in cortisol level	Cortisol is one of the main hormones released by the body as a reaction to stress.	Baseline and one hour
Change from Baseline in alpha-Amylase	Salivary alpha-Amylase	Baseline and one hour after dental intervention

Collaborators and Investigators

• Sponsor: Charite University, Berlin, Germany
• Investigators: Principal Investigator: Andreas Ströhle, Prof. Dr., Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin

Study record dates

Study Major Dates

• Study Start: August 1, 2011
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: July 26, 2013
• First Submitted That Met QC Criteria: August 30, 2013
• First Posted (Estimate): September 2, 2013

Study Record Updates

• Last Update Posted (Estimate): February 9, 2015
• Last Update Submitted That Met QC Criteria: February 6, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Dental Anxiety, Physical Activity, Dental Phobia; Cortisol, Amylase
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: 221014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No