Exercise Treatment of Dental Anxiety

NCT ID: NCT01933191

Last Updated: 2015-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2013-10-31

Brief Summary

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

Detailed Description

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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

Conditions

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Dental Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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physical acticity

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

Group Type EXPERIMENTAL

Aerobic treadmill exercise

Intervention Type BEHAVIORAL

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 exercise

Intervention Type BEHAVIORAL

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).

placebo exercise

Aerobic treadmill exercise (30 minutes, 20% VO2max)

Group Type PLACEBO_COMPARATOR

Aerobic treadmill exercise

Intervention Type BEHAVIORAL

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 exercise

Intervention Type BEHAVIORAL

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).

Interventions

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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).

Intervention Type 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).

Intervention Type BEHAVIORAL

Other Intervention Names

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physical activity VO2-70% physical activity VO2-20%

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Charite University, Berlin, Germany

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Andreas Ströhle

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Andreas Ströhle, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin

Locations

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Department of Psychiatry and Psychotherapy Campus Charité Mitte

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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221014

Identifier Type: -

Identifier Source: org_study_id

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