Exercise Treatment of Dental Anxiety

NCT01933191 | Completed

• 1 other identifier: 221014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Anxiety

Keywords

Dental Anxiety, Physical Activity, Dental Phobia; Cortisol, Amylase

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change from Baseline in cortisol level

  Baseline and one hour

• Change from Baseline in alpha-Amylase

  Baseline and one hour after dental intervention

Study Arms (2)

physical acticity

EXPERIMENTAL

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

Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise

placebo exercise

PLACEBO COMPARATOR

Aerobic treadmill exercise (30 minutes, 20% VO2max)

Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise

Interventions

Aerobic treadmill exercise 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).

Also known as: physical activity VO2-70%

physical acticity; placebo exercise

placebo exercise 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).

Also known as: physical activity VO2-20%

physical acticity; placebo exercise

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Department of Psychiatry and Psychotherapy Campus Charité Mitte

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Andreas Ströhle, Prof. Dr.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr.

Study Record Dates

• First Submitted: July 26, 2013
• First Posted: September 2, 2013
• Study Start: August 1, 2011
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

DE (1)