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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04949126
Other study ID # RNI 2021 COUSSON
Secondary ID 2021-A00417-34
Status Completed
Phase
First received
Last updated
Start date June 15, 2021
Est. completion date May 12, 2023

Study information

Verified date June 2023
Source University Hospital, Clermont-Ferrand
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

To describe and understand the self-medication behaviours of a population of adults coming to the Clermont-Ferrand dentistry department for acute pain of pulpal origin and of a population of adults coming to the specific care unit of the Clermont-Ferrand dentistry department or the Riom hospital for treatment under general anaesthesia.


Description:

Self-medication behaviour will be studied by means of a questionnaire. Questionnaires on insecurity, anxiety about dental care, items related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF), a visual analogue pain assessment scale and the PCS-CF pain dramatisation scale will also be used.


Recruitment information / eligibility

Status Completed
Enrollment 940
Est. completion date May 12, 2023
Est. primary completion date May 12, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult patient, male or female, coming to consult in the Clermont-Ferrand or Riom Hospital for acute pain of pulp origin and periapical OR eligible for dental treatment under general anesthesia in a context phobic. - Understanding and practicing French - giving informed consent to participate in research. - Affiliation to a Social Security scheme. Exclusion Criteria: - Patients under guardianship. - Patient's refusal to participate in the study.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
questionnaire
questionnaires of precarity, dental anxiety, self medication, pain

Locations

Country Name City State
France CHU de Clermont-Ferrand Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary description of the self-medication behaviours evaluated by patient interrogation day 0
Secondary level of anxiety : evaluated with IDAF 4C (anxiety module between 8-40, phobia module between 5-10 and anxious situations between 10 and 50), the higher the score, the more anxious the patient is day 0
Secondary level of insecurity evaluated by questionnaire (EPICES (the patient is in situation of insecurity if the score is higher than 30)) day 0
Secondary description of the oral health with the related to the ingestion function of the International Classification of Functioning, Disability and Health (ICF) each item is evaluated with a Lickert scale day 0
Secondary visual analogue pain assessment scale and the PCS-CF pain dramatisation scale PCS-CF scale is evaluated between 0 and 52, the higher the score, the more patient is over reacting faced with pain Day 0
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