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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| physical acticity | Experimental | Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max) |
|
| placebo exercise | Placebo Comparator | Aerobic treadmill exercise (30 minutes, 20% VO2max) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andreas Ströhle, Prof. Dr. | Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Psychiatry and Psychotherapy Campus Charité Mitte | Berlin | 10117 | Germany |
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| ID | Term |
|---|---|
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001519 | Behavior |
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|
| 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). |
|
|
| Baseline and one hour after dental intervention |