- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03165448
Validation of Universal Scale in Oral Surgery (USOS) for Patient's Psycho-emotional Status Rating
Study Overview
Status
Conditions
Detailed Description
Patient's discomfort ant doctor's negative emotional feelings in various dental procedures are related to patient's psycho-emotional status during the procedure. Three main factors, determining patient's psycho-emotional status, were determined in earlier studies: fear, stress and pain sensitivity.
Different elements cause patient's fear, stress and pain sensitivity, therefore in order to improve patient's psycho-emotional status, the causative element should be known. Multifactority o human's psycho-emotional status is described by anatomy - emotional state depends on amygdala (lat. corpus amygdaloideum) and cerebellum (lat. cerebellum), which interaction is related to development of fear to negative irritants. This process arise from two steps learning system - negative experience may cause fear and corresponding reactions. Dejean et al stated, that the main locations, in which memories causing fear are kept, are in dorsomedial prefrontal cortex. In this area 4Hz frequency vibrations are found during the fearful reactions. Neurologic examinations prove that emotional-physical relationships are firm and negative emotions may cause various reactions in organism. However, changes caused by fear, that are found in brain, are not specific. Various emotions may cause different vibrations in specific recurrent cortex locations, therefore it is important to rate full psycho-emotional status complex.
When the present of fears and phobias were examined, fear to dental treatment is in top-5 of all fears and in phobias - it is number one. The strength of dental fear may vary according to the upcoming procedure. Oosterink et al found that out of 67 dental procedures, oral surgery is the most terrifying for patients. When only oral surgery procedures were examined, third molar extraction was found as most fear producing.
Pain sensitivity - the other important part of patient's psycho-emotional status, which is described as patient's painful reaction to minimal stimulus and opportunity to maintain the maximum pain. Even though the pain is usually described as reaction to physical stimulus, it is closely related to patient's psychology. Previous pain experience may generate negative memories, which cause more sensitivity in repeated procedure. Also, it is known that stronger pain may be felt if it was expected before. Only physical methods to control the pain are not always effective - patient's psycho-emotional status correction is needed in better control of pain, which can be achieved with non-interventional methods.
Stress is usually described as physical reactions provoked by negative stimulus, which arise with active sympathetic nervous system and behavioral changes. It should be noted, that fear and felt pain may cause stress. Also, it was found that long term felt stress may cause chronic pains evaluations and vice versa - any pain felt provokes stressful reactions in human's body. Therefore, stress as physiological reactions arise because of painful interventions, same as for physiological fear - stimuli, that are constantly present during oral surgery procedures.
Nowadays there are various medication and non-medication methods to control patient's fear, stress and pain sensitivity in dental procedures. However, in order to examine effectivity of these methods and overall the problem of patient's psycho-emotional status, measures are needed. In earlier studies it was found that various general instruments are used to rate patient's fear and anxiety before teeth extraction procedures. Because of non-standardized rating, studies because such heterogeneous, that the results are incomparable between each other. The use of different questionnaires often showed different results even in the same situations. Because of their properties and actuality of the problem, there is a need to standardize patient's psycho-emotional status evaluation methods, with a use of practically adaptable measures.
Universal Scale in Oral Surgery (USOS) for patient's psycho-emotional status evaluation, composed from patient's reported part and doctor's reported part, was designed in earlier study by authors. The aim of present study is to assess the clinical effectivity and validate the USOS in case of outpatient tooth extraction for adult healthy patients.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adult patients (18 years and more), who need routine tooth extraction
- No contraindications for outpatient tooth extraction
- Tooth extraction with local anesthesia
- Voluntary participation in the study
- Patients, that can fill questionnaires and enroll in the study by selves
Exclusion Criteria:
- Under-age patients and adult patients, who need inpatient tooth extraction
- Contraindications for outpatients tooth extraction
- Tooth extraction with general anesthesia or sedation
- Disagreement of participation in study
- Patients, that were unable to fill questionnaires and enroll the study by selves
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Self-reported questions
All the participants will enroll the same study protocol, without any exceptions: pre-operative patient's self-reported questioning, post-operative doctor's questioning, 4-6 weeks patients retesting.
|
Patient has to self-report USOS questionnaire just before the procedure as main scale.
Patient has to sel-report SDPQ, MDAS and VAS questions as control scales.
Operating doctor has to fill the USOS doctor's part o questionnaire just after the procedure.
All the participants has to refill USOS questionnaire 4-6 weeks later.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Correlation between USOS and control scales
Time Frame: The same day of the tooth extraction procedure
|
The correlation degrees between USOS mean values and control scales mean values will be calculated.
|
The same day of the tooth extraction procedure
|
Correlation between patient's and doctor's results
Time Frame: The same day of the tooth extraction procedure
|
Correlations between patient's USOS part and doctor's USOS part will be calculated.
|
The same day of the tooth extraction procedure
|
Re-testing o USOS
Time Frame: At 4-6 weeks time period, when USOS is being re-tested
|
Correlation between USOS and re-tested USOS 4-6 weeks later will be calculated.
|
At 4-6 weeks time period, when USOS is being re-tested
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sex influence on patient's psycho-emotional status
Time Frame: The same day of the tooth extraction procedure
|
The differences among men and women will be observed
|
The same day of the tooth extraction procedure
|
Age influence on patient's psycho-emotional status
Time Frame: The same day of the tooth extraction procedure
|
The differences between people with different age will be observed
|
The same day of the tooth extraction procedure
|
Experience influence on patient's psycho-emotional status
Time Frame: The same day of the tooth extraction procedure
|
Calculations, weather injectional anesthesia and oral surgery procedures experience influence the outcomes, will be performed
|
The same day of the tooth extraction procedure
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- USOS validation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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