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Exercise Treatment of Dental Anxiety

Primary Purpose

Dental Anxiety

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Aerobic treadmill exercise
placebo exercise
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Anxiety focused on measuring Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy Campus Charité Mitte

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

physical acticity

placebo exercise

Arm Description

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

Aerobic treadmill exercise (30 minutes, 20% VO2max)

Outcomes

Primary Outcome Measures

Change from Baseline in VAS - visual analog scale
Change in the visual analogue scale (VAS) for anxiety

Secondary Outcome Measures

Change from Baseline in cortisol level
Cortisol is one of the main hormones released by the body as a reaction to stress.
Change from Baseline in alpha-Amylase
Salivary alpha-Amylase

Full Information

First Posted
July 26, 2013
Last Updated
February 6, 2015
Sponsor
Charite University, Berlin, Germany
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1. Study Identification

Unique Protocol Identification Number
NCT01933191
Brief Title
Exercise Treatment of Dental Anxiety
Official Title
A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety
Study Type
Interventional

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Anxiety
Keywords
Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical acticity
Arm Type
Experimental
Arm Description
Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max)
Arm Title
placebo exercise
Arm Type
Placebo Comparator
Arm Description
Aerobic treadmill exercise (30 minutes, 20% VO2max)
Intervention Type
Behavioral
Intervention Name(s)
Aerobic treadmill exercise
Other Intervention Name(s)
physical activity VO2-70%
Intervention Description
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
Intervention Name(s)
placebo exercise
Other Intervention Name(s)
physical activity VO2-20%
Intervention Description
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).
Primary Outcome Measure Information:
Title
Change from Baseline in VAS - visual analog scale
Description
Change in the visual analogue scale (VAS) for anxiety
Time Frame
Baseline and one hour after dental intervention
Secondary Outcome Measure Information:
Title
Change from Baseline in cortisol level
Description
Cortisol is one of the main hormones released by the body as a reaction to stress.
Time Frame
Baseline and one hour
Title
Change from Baseline in alpha-Amylase
Description
Salivary alpha-Amylase
Time Frame
Baseline and one hour after dental intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Ströhle, Prof. Dr.
Organizational Affiliation
Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy Campus Charité Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

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