Fear, DentalNCT03165448
Validation of Universal Scale in Oral Surgery (USOS) for Patient's Psycho-emotional Status Rating
An observational study of Fear, Dental, run by Inesa Astramskaitė.
Trial summary
Patient's psycho-emotional status is being affected during various dental procedures causing patient's and doctor's discomfort. There are three basic factors, composing psycho-emotional status: fear, stress and pain sensitivity. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fear, Dental
- What is being tested?
- Pre-operative USOS scale testing, Pre-operative SDPQ, MDAS and VAS testing and Post-operative doctor's reported USOS
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2016to 1 Apr 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult patients that came to Lithuanian university o health sciences, Department o oral and maxillofacial surgery clinic or outpatient tooth extraction were randomly selected.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Patient's psycho-emotional status is being affected during various dental procedures causing patient's and doctor's discomfort. There are three basic factors, composing psycho-emotional status: fear, stress and pain sensitivity. There aren't any objective method that may help in standard evaluation of oral surgery patient's psycho-emotional status. In the present non-standardized evaluation, there is a problem of heterogeneity between studies, and also ineffective patient's evaluation. Therefore, Universal Scale in oral surgery for patient's psycho-emotional status rating (USOS) was designed. Clinical trial to validate the USOS was constructed.
Read the 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.
- Conditions
- Fear, Dental
- Being tested
- Pre-operative USOS scale testing, Pre-operative SDPQ, MDAS and VAS testing, Post-operative doctor's reported USOS, Re-testing 4-6 weeks later
- Keywords
- oral surgery, psychology, fear, pain, dentistry
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-operative USOS scale testingDiagnostic test
Patient has to self-report USOS questionnaire just before the procedure as main scale.
Pre-operative SDPQ, MDAS and VAS testingDiagnostic test
Patient has to sel-report SDPQ, MDAS and VAS questions as control scales.
Post-operative doctor's reported USOSDiagnostic test
Operating doctor has to fill the USOS doctor's part o questionnaire just after the procedure.
Re-testing 4-6 weeks laterDiagnostic test
All the participants has to refill USOS questionnaire 4-6 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Pre-operative USOS scale testing; Diagnostic Test: Pre-operative SDPQ, MDAS and VAS testing; Diagnostic Test: Post-operative doctor's reported USOS; Diagnostic Test: Re-testing 4-6 weeks later |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between USOS and control scales
The correlation degrees between USOS mean values and control scales mean values will be calculated.
Measured: The same day of the tooth extraction procedure
Correlation between patient's and doctor's results
Correlations between patient's USOS part and doctor's USOS part will be calculated.
Measured: The same day of the tooth extraction procedure
Re-testing o USOS
Correlation between USOS and re-tested USOS 4-6 weeks later will be calculated.
Measured: At 4-6 weeks time period, when USOS is being re-tested
Secondary outcomes (3)
Sex influence on patient's psycho-emotional status
The differences among men and women will be observed
Measured: The same day of the tooth extraction procedure
Age influence on patient's psycho-emotional status
The differences between people with different age will be observed
Measured: The same day of the tooth extraction procedure
Experience influence on patient's psycho-emotional status
Calculations, weather injectional anesthesia and oral surgery procedures experience influence the outcomes, will be performed
Measured: The same day of the tooth extraction procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study start1 May 2016
- Primary completion1 Dec 2016
- Study completion1 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fear, DentalStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inesa Astramskaitė
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Inesa Astramskaitė, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165448
- Sponsor's protocol ID
- USOS validation
- Status last verified
- May 2017
- First submitted
- 21 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participants data is not important or study outcomes and will not be shared in any circumstances.
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Universal Scale in Oral Surgery (USOS) for Patient's Psycho-emotional Status Rating
- ClinicalTrials.gov ID
- NCT03165448
- Acronym / sponsor ID
- USOS validation
- Conditions
- Fear, Dental
- Keywords
- oral surgery, psychology, fear, pain, dentistry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Inesa AstramskaitėUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 1 Apr 2017 (actual)
- First posted
- 24 May 2017 (actual)
- 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.
Patient's psycho-emotional status is being affected during various dental procedures causing patient's and doctor's discomfort. There are three basic factors, composing psycho-emotional status: fear, stress and pain sensitivity. There aren't any objective method that may help in standard evaluation of oral surgery patient's psycho-emotional status. In the present non-standardized evaluation, there is a problem of heterogeneity between studies, and also ineffective patient's evaluation. Therefore, Universal Scale in oral surgery for patient's psycho-emotional status rating (USOS) was designed. Clinical trial to validate the USOS was constructed.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Self-reported questions | – | Diagnostic Test: Pre-operative USOS scale testing, Diagnostic Test: Pre-operative SDPQ, MDAS and VAS testing, Diagnostic Test: Post-operative doctor's reported USOS, Diagnostic Test: Re-testing 4-6 weeks laterAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult patients that came to Lithuanian university o health sciences, Department o oral and maxillofacial surgery clinic or outpatient tooth extraction were randomly selected.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Pre-operative USOS scale testingPatient has to self-report USOS questionnaire just before the procedure as main scale. | Diagnostic test | Self-reported questions |
| Pre-operative SDPQ, MDAS and VAS testingPatient has to sel-report SDPQ, MDAS and VAS questions as control scales. | Diagnostic test | Self-reported questions |
| Post-operative doctor's reported USOSOperating doctor has to fill the USOS doctor's part o questionnaire just after the procedure. | Diagnostic test | Self-reported questions |
| Re-testing 4-6 weeks laterAll the participants has to refill USOS questionnaire 4-6 weeks later. | Diagnostic test | Self-reported questions |
Primary outcome
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.
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.
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.
3 secondary outcomes
Sex influence on patient's psycho-emotional status
Time frame: 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
Experience influence on patient's psycho-emotional status
Time frame: The same day of the tooth extraction procedure
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 24 May 2017.
- Individual participant dataSharing planned: No. Individual participants data is not important or study outcomes and will not be shared in any circumstances.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear, Dental, run by Inesa Astramskaitė.
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 5 inclusion and 5 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 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Correlation between USOS and control scales (time frame: The same day of the tooth extraction procedure). The study lists 3 primary outcomes in all. 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 24 May 2017.