Stress Factors Induced by Patient and Young Clinicien During Endodontic Treatment

NCT03217760 | Completed

• 1 other identifier: STRESSENDO (16.118)
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this pilot study is to examine the patient's induced stress and the young dentist's induced stress, during endodontic treatment. This study is carried out using physiologic (cortisol measurement, arterial pressure and heart rate) and psychological data (VAS visual analog scale of stress, pain and discomfort, CORAH and HAD Scales) collected from patients of Brest University Dental Hospital at various stages of root canal treatment. The endodontic treatment is carried out under the usual standards and practices.

Conditions

Endodontic Treatment

Keywords

Induced stress, dental anxiety, endodontic treatment, salivary cortisol, cardiovascular parameters, pain, discomfort.

Outcome Measures

Primary Outcomes (1)

• The main study criteria is the variation of stress.

  At the 6 steps of the treatment and at the next visit for the final restoration, both subjects (patient and student) are asked to use a visual analog scale (VAS) to score the level of stress specifically induced by the endodontic treatment. The VAS is a 10-cm scale without graduation on which subjects are asked to score the specific level of stress experienced from 0 (not stressed at all) to 10 (worst stress imaginable). The VAS of stress has proven to be a valid tool that is highly sensitive to change.

  At the 6 steps of the treatment and at the next visit for the final restoration : up to 15 days

Secondary Outcomes (7)

• CORAH .

  At the beginning of the treatment (T1) : one day

• HAD Scales.

  At the beginning of the treatment (T1) : one day

• Cardiovascular Parameters

  During endodontie treatment (one day) and at the next visit for the final restoration (15 days after).

• Cardiovascular Parameters

  During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)

• Cardiovascular Parameters

  During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)

Study Arms (2)

Patients

The main aim of the study is to examine the patient's induced stress during endodontic treatment in order to offer customised solutions to lessen stress. The other aims is also to evaluate the patient's pain and discomfort during endodontic treatment.

Other: VAS of stress; Other: CORAH scale; Other: HAD Scale; Other: Cardiovascular Parameters; Other: Cortisol Measurements; Other: Discomfort and Pain Experienced During Treatment; Other: Patient's preferences.

Young dentists practitioners.

The other aims are to evaluate the young dentist's induced stress and to examine and compare the patient's induced stress and the young dentist's induced stress.

Procedure: Endodontic treatment; Other: VAS of stress; Other: HAD Scale; Other: Cardiovascular Parameters; Other: Cortisol Measurements; Other: student preferences.

Interventions

Endodontic treatment PROCEDURE

Endodontic treatment or root canal therapy is a sequence of treatment for the infected pulp of a tooth which results in the elimination of infection and the protection of the decontaminated tooth from future microbial invasion.

Young dentists practitioners.

VAS of stress OTHER

The VAS is a 10-cm scale without graduation on which subjects are asked to score the specific level of stress experienced from 0 (not stressed at all) to 10 (worst stress imaginable)

Patients; Young dentists practitioners.

CORAH scale OTHER

At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS).

Patients

HAD Scale OTHER

At the beginning of the treatment (T1), patients and students are asked to complete the Hospital Anxiety and Depression Scale (HAD Scale) which is presented as a reliable instrument for assessing clinically significant anxiety and depression.

Patients; Young dentists practitioners.

Cardiovascular Parameters OTHER

For each subject, the physiological indicators of stress (ie, heart rate \[HR\], systolic blood pressure \[SBP\], and diastolic blood pressure \[DBP\]) are monitored during each of the 6 steps.

Patients; Young dentists practitioners.

Cortisol Measurements OTHER

Salivary samples are collected during each of the 6 steps of endodontic treatment which are then stored at -20° before being sent to the laboratory to test cortisol levels .

Patients; Young dentists practitioners.

Discomfort and Pain Experienced During Treatment OTHER

Patients were asked to report the levels of discomfort and pain experienced during the 6 steps using the VAS and at the next visit for the final restoration.

Patients

Patient's preferences. OTHER

After the completion of each treatment patients will have to report whether they thought that they would have experienced as much pain, stress, or discomfort if they had received premedication before treatment.

Patients

student preferences. OTHER

When the treatment is complete the students are asked to report: 1. his/her level of satisfaction with the course of treatment, 2. whether he/she felt awkward faced with the patient's manifestations of stress, discomfort, or pain during the session 3. whether he/she would have preferred that the patient had received sedative medication before the endodontic treatment.

Young dentists practitioners.

Eligibility Criteria

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

Study Population

30 patients and students were needed.

You may qualify if:

• Patients between 18 and 60 years old
• Patients who need endodontic treatment
• Patients insured under the French social security system

You may not qualify if:

• Pregnant women
• Participants refusing to take part
• Patients not fluent in French.
• Patients who have certain diseases which do not allow interpretion of the cardiovascular outcomes (cardiac rhythm disorder, hypertension)
• Treatments or diseases which may have profound implications on stress modulation
• Certain diseases which affect cortisol levels: Cushing, Addison, obesity (body mass index (BMI) \> 30 kg/m²), schizophrenia, personality and behaviour disorders.

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Salivary samples are collected during endodontic treatment to measure cortisol production during endodontic treatment. Cortisol is a hormone secreted from the adrenal cortex and dispersed to all body fluids (urine, serum, or saliva). A correlation between salivary cortisol levels and stress in dental procedure is noticed.

MeSH Terms

Conditions

Pain

Interventions

Endodontics

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dentistry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Month
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2017
• First Posted: July 14, 2017
• Study Start: March 28, 2017
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: April 25, 2018

Record last verified: 2018-04

Locations

FR (1)