Endodontic TreatmentSTRESSENDONCT03217760
Stress Factors Induced by Patient and Young Clinicien During Endodontic Treatment
An observational study of Endodontic Treatment, run by University Hospital, Brest at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Treatment
- What is being tested?
- Endodontic treatment, VAS of stress and CORAH scale
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2017to 19 Apr 2018
- How long will I take part?
- 1 Month
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 30 patients and students were needed.
Who may be able to join
- Patients between 18 and 60 years old
- Patients who need endodontic treatment
- Patients insured under the French social security system
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Patient's Induced Stress and Young Practitioner's Induced Stress During Endodontic Therapy.
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.
Read the detailed description
Thirty patients and students are involved. All adult patients referred to the dental department for initial endodontic treatment are given the option of taking part, excluding those presenting cardiovascular disease or mental, psychiatric, or neuronal disease. Patients taking antihypertensive treatment, anxiolytics, sedatives, or neuroleptic drugs are also excluded from the study. Thirty dental students will conduct endodontic treatments according to the regular local procedures. No patient receives any sedative premedication.
The indicators of stress are monitored at 6 steps of endodontic treatment:
T1: preoperative rest; T2: local anaesthesia (4% articaïne hydrochloride with 1:200 000 epinephrine). T3: rubber-dam set-up T4: root canal instrumentation T5: root canal filling T6: postoperative rest
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.
Other study criteria:
- CORAH and HAD Scales At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS). This questionnaire consists of 4 parts: the results lead to the assessment of dental anxiety.
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 in patients.
- Cardiovascular Parameters 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.
- Cortisol Measurements A correlation between salivary cortisol level and stress in dental procedure was noticed .
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 .
- Discomfort and Pain Experienced During Treatment Dental anxiety was found to have a direct relationship with pain perception (). 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.
- Patient and student preferences After the completion of each scale 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.
When the treatment is complete the students are asked to report:
- his/her level of satisfaction with the course of treatment,
- whether he/she felt awkward faced with the patient's manifestations of stress, discomfort, or pain during the session
- whether he/she would have preferred that the patient had received sedative medication before the endodontic treatment.
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 are to evaluate the young dentist's induced stress, to examine and compare the patient's induced stress and the young dentist's induced stress, and to evaluate the patient's pain and discomfort during endodontic treatment.
The results of this observational study are to be used as a reference for future interventional studies to reduce stress during endodontic treatment. Techniques such as relaxation, hypnosis, acupuncture, distraction, music therapy, positive reinforcement, stop-signalling, and exposure-based treatments, "tell-show-do" are some solutions which could be initiated at the dentistry department of CHRU Brest.
- Conditions
- Endodontic Treatment
- Being tested
- Endodontic treatment, VAS of stress, CORAH scale, HAD Scale, Cardiovascular Parameters
- Keywords
- Induced stress, dental anxiety, endodontic treatment, salivary cortisol, cardiovascular parameters, pain, discomfort.
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endodontic treatmentProcedure or surgery
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.
VAS of stressOther
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)
CORAH scaleOther
At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS).
HAD ScaleOther
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.
Cardiovascular ParametersOther
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.
Cortisol MeasurementsOther
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 .
Discomfort and Pain Experienced During TreatmentOther
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.
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.
student preferences.Other
When the treatment is complete the students are asked to report:
- his/her level of satisfaction with the course of treatment,
- whether he/she felt awkward faced with the patient's manifestations of stress, discomfort, or pain during the session
- whether he/she would have preferred that the patient had received sedative medication before the endodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Endodontic treatment; Other: VAS of stress; Other: HAD Scale; Other: Cardiovascular Parameters; Other: Cortisol Measurements; Other: student preferences. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS). This questionnaire consists of 4 parts: the results lead to the assessment of dental anxiety.
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 in patients.
Measured: At the beginning of the treatment (T1) : one day
HAD Scales.
At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS). This questionnaire consists of 4 parts: the results lead to the assessment of dental anxiety.
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 in patients.
Measured: At the beginning of the treatment (T1) : one day
Cardiovascular Parameters
For each subject, the physiological indicators of stress (heart rate [HR]) are monitored during each of the 6 steps.
Measured: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after).
Cardiovascular Parameters
For each subject, the physiological indicators of stress (systolic blood pressure [SBP]) are monitored during each of the 6 steps.
Measured: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)
Cardiovascular Parameters
For each subject, the physiological indicators of stress (diastolic blood pressure [DBP]) are monitored during each of the 6 steps.
Measured: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)
Cortisol Measurements
A correlation between salivary cortisol level and stress in dental procedure was noticed.
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 .
Measured: During endodontic treatment (one day).
Discomfort and Pain Experienced During Treatment
Dental anxiety was found to have a direct relationship with pain perception ((Sathorn et al., 2008)). 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.
Measured: During endodontic treatment (one day) and at the next visit for the final restoration (15 days after).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start28 Mar 2017
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic TreatmentStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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
- 60 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03217760
- Sponsor's protocol ID
- STRESSENDO (16.118)
- Acronym
- STRESSENDO
- Status last verified
- Apr 2018
- First submitted
- 20 Jun 2017
- Last updated
- 25 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient's Induced Stress and Young Practitioner's Induced Stress During Endodontic Therapy.
- ClinicalTrials.gov ID
- NCT03217760
- Acronym / sponsor ID
- STRESSENDO / STRESSENDO (16.118)
- Conditions
- Endodontic Treatment
- Keywords
- Induced stress, dental anxiety, endodontic treatment, salivary cortisol, cardiovascular parameters, pain, discomfort.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 14 Jul 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.
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.
Detailed description
Thirty patients and students are involved. All adult patients referred to the dental department for initial endodontic treatment are given the option of taking part, excluding those presenting cardiovascular disease or mental, psychiatric, or neuronal disease. Patients taking antihypertensive treatment, anxiolytics, sedatives, or neuroleptic drugs are also excluded from the study. Thirty dental students will conduct endodontic treatments according to the regular local procedures. No patient receives any sedative premedication.
The indicators of stress are monitored at 6 steps of endodontic treatment:
T1: preoperative rest; T2: local anaesthesia (4% articaïne hydrochloride with 1:200 000 epinephrine). T3: rubber-dam set-up T4: root canal instrumentation T5: root canal filling T6: postoperative rest
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.
Other study criteria:
- CORAH and HAD Scales At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS). This questionnaire consists of 4 parts: the results lead to the assessment of dental anxiety.
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 in patients.
- Cardiovascular Parameters 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.
- Cortisol Measurements A correlation between salivary cortisol level and stress in dental procedure was noticed .
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 .
- Discomfort and Pain Experienced During Treatment Dental anxiety was found to have a direct relationship with pain perception (). 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.
- Patient and student preferences After the completion of each scale 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.
When the treatment is complete the students are asked to report:
- his/her level of satisfaction with the course of treatment,
- whether he/she felt awkward faced with the patient's manifestations of stress, discomfort, or pain during the session
- whether he/she would have preferred that the patient had received sedative medication before the endodontic treatment.
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 are to evaluate the young dentist's induced stress, to examine and compare the patient's induced stress and the young dentist's induced stress, and to evaluate the patient's pain and discomfort during endodontic treatment.
The results of this observational study are to be used as a reference for future interventional studies to reduce stress during endodontic treatment. Techniques such as relaxation, hypnosis, acupuncture, distraction, music therapy, positive reinforcement, stop-signalling, and exposure-based treatments, "tell-show-do" are some solutions which could be initiated at the dentistry department of CHRU Brest.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | 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.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. |
| Young dentists practitioners. | – | Procedure: Endodontic treatment, Other: VAS of stress, Other: HAD Scale, Other: Cardiovascular Parameters, Other: Cortisol Measurements, Other: student preferences.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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 30 patients and students were needed.
Key inclusion criteria (3 listed)
- Patients between 18 and 60 years old
- Patients who need endodontic treatment
- Patients insured under the French social security system
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Endodontic treatmentEndodontic 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. | Procedure or surgery | Young dentists practitioners. |
| VAS of stressThe 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) | Other | Patients, Young dentists practitioners. |
| CORAH scaleAt the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS). | Other | Patients |
| HAD ScaleAt 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. | Other | Patients, Young dentists practitioners. |
| Cardiovascular ParametersFor 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. | Other | Patients, Young dentists practitioners. |
| Cortisol MeasurementsSalivary 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 . | Other | Patients, Young dentists practitioners. |
| Discomfort and Pain Experienced During TreatmentPatients 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. | Other | Patients |
| Patient's preferences.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. | Other | Patients |
| student preferences.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. | Other | Young dentists practitioners. |
Primary outcome
The main study criteria is the variation of stress.
Time frame: At the 6 steps of the treatment and at the next visit for the final restoration : up to 15 days
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.
7 secondary outcomes
CORAH .
Time frame: At the beginning of the treatment (T1) : one day
HAD Scales.
Time frame: At the beginning of the treatment (T1) : one day
Cardiovascular Parameters
Time frame: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after).
Cardiovascular Parameters
Time frame: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)
Cardiovascular Parameters
Time frame: During endodontie treatment (one day) and at the next visit for the final restoration (15 days after)
Cortisol Measurements
Time frame: During endodontic treatment (one day).
Discomfort and Pain Experienced During Treatment
Time frame: During endodontic treatment (one day) and at the next visit for the final restoration (15 days after).
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 25 Apr 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endodontic Treatment, run by University Hospital, Brest at 1 site in France.
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 3 inclusion and 6 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 25 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The main study criteria is the variation of stress. (time frame: At the 6 steps of the treatment and at the next visit for the final restoration : up to 15 days). 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 25 Apr 2018.