Validation of Universal Scale in Oral Surgery (USOS) for Patient's Psycho-emotional Status Rating

NCT03165448 | Completed

• 1 other identifier: USOS validation
• Study Type: observational
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Fear, Dental

Keywords

oral surgery; psychology; fear; pain; dentistry

Outcome Measures

Primary Outcomes (3)

• Correlation between USOS and control scales

  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

  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

  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 Outcomes (3)

• Sex influence on patient's psycho-emotional status

  The same day of the tooth extraction procedure

• Age influence on patient's psycho-emotional status

  The same day of the tooth extraction procedure

• Experience influence on patient's psycho-emotional status

  The same day of the tooth extraction procedure

Study Arms (1)

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.

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

Interventions

Pre-operative USOS scale testing DIAGNOSTIC_TEST

Patient has to self-report USOS questionnaire just before the procedure as main scale.

Self-reported questions

Pre-operative SDPQ, MDAS and VAS testing DIAGNOSTIC_TEST

Patient has to sel-report SDPQ, MDAS and VAS questions as control scales.

Self-reported questions

Post-operative doctor's reported USOS DIAGNOSTIC_TEST

Operating doctor has to fill the USOS doctor's part o questionnaire just after the procedure.

Self-reported questions

Re-testing 4-6 weeks later DIAGNOSTIC_TEST

All the participants has to refill USOS questionnaire 4-6 weeks later.

Self-reported questions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Inesa Astramskaitė: lead

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 21, 2017
• First Posted: May 24, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: April 1, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share