Dental AnxietyNCT01933191
Exercise Treatment of Dental Anxiety
A study testing Aerobic treadmill exercise in people with Dental Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
A single bout of physical activity (treadmill)immediately prior to the dental examination reduces anxiety in patients with dental phobia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Dental Anxiety
- What is being tested?
- Aerobic treadmill exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2011to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy Campus Charité Mitte
Berlin, 10117
About this study
Official title: 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.
Read the 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
- Conditions
- Dental Anxiety
- Being tested
- Aerobic treadmill exercise, placebo exercise
- Keywords
- Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic treadmill exerciseBehavioural
Also called physical activity VO2-70%
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 exerciseBehavioural
Also called physical activity VO2-20%
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).
| Study group | Role | What they receive |
|---|---|---|
| physical acticity | Experimental | Experimental: Aerobic treadmill exercise (30 minutes, 70% VO2max) Receives: Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise |
| placebo exercise | Placebo comparator | Aerobic treadmill exercise (30 minutes, 20% VO2max) Receives: Behavioral: Aerobic treadmill exercise; Behavioral: placebo exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in VAS - visual analog scale
Change in the visual analogue scale (VAS) for anxiety
Measured: Baseline and one hour after dental intervention
Secondary outcomes (2)
Change from Baseline in cortisol level
Cortisol is one of the main hormones released by the body as a reaction to stress.
Measured: Baseline and one hour
Change from Baseline in alpha-Amylase
Salivary alpha-Amylase
Measured: Baseline and one hour after dental intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2013 (estimated)
- Study startAug 2011
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Andreas Ströhle, Charite University, Berlin, Germany
- Investigators
- Andreas Ströhle, Prof. Dr., Principal investigator, Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01933191
- Sponsor's protocol ID
- 221014
- Status last verified
- Feb 2015
- First submitted
- 26 Jul 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Placebo Controlled Cross-over Trial on Exercise Treatment of Dental Anxiety
- ClinicalTrials.gov ID
- NCT01933191
- Acronym / sponsor ID
- 221014
- Conditions
- Dental Anxiety
- Keywords
- Dental Anxiety, Physical Activity, Dental Phobia, Cortisol, Amylase
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 2 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical acticity | Experimental | Behavioral: Aerobic treadmill exercise, Behavioral: placebo exerciseExperimental: Aerobic treadmill exercise (30 minutes, 70% VO2max) |
| placebo exercise | Placebo comparator | Behavioral: Aerobic treadmill exercise, Behavioral: placebo exerciseAerobic treadmill exercise (30 minutes, 20% VO2max) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic treadmill exerciseAlso: physical activity VO2-70%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). | Behavioural | physical acticity, placebo exercise |
| placebo exerciseAlso: physical activity VO2-20%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). | Behavioural | physical acticity, placebo exercise |
Primary outcome
Change from Baseline in VAS - visual analog scale
Time frame: Baseline and one hour after dental intervention
Change in the visual analogue scale (VAS) for anxiety
2 secondary outcomes
Change from Baseline in cortisol level
Time frame: Baseline and one hour
Change from Baseline in alpha-Amylase
Time frame: Baseline and one hour after dental intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andreas Ströhle, Prof. Dr. principal investigator
Department of Psychiatry and Psychotherapie, CCM, Charité-Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic treadmill exercise in people with Dental Anxiety, run by Charite University, Berlin, Germany at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in VAS - visual analog scale (time frame: Baseline and one hour after dental intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2015.