Endodontic Disease Clinical Trial
— MUSIQUENDOOfficial title:
Evaluation of the Effect of Music on Young Practitioner's Stress During Endodontic Treatment
According to several studies, patients consider endodontic treatment as one of the most stress-inducing dental procedures. Two studies demonstrated that music enables the patient to be less stressed during RCT. RCTs are also stressful for the practitioner, and particularly for students who start their dental practice. Endodontic and prosthetic cares are considered the most demanding by students. RCT requires high degree of precision in gestures and patience because those technical acts are, in part, blindly realised and can be long. In a preliminary study, it was found that the most stress-inducing steps for the students during endodontic treatment are root-canal preparation and filling. The beneficial side of listening to music on the patient's stress during RCT has been proved; but to our knowledge, no study assessed the effect of listening to music on the stress of the practitioner and more particularly of the young practitioner, during endodontic treatment, and in particular during root canal preparation. This is the main aim of this study.
Status | Recruiting |
Enrollment | 176 |
Est. completion date | December 9, 2022 |
Est. primary completion date | December 9, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 70 Years |
Eligibility | Inclusion Criteria: Patient: - person between 18 and 70 years old - patient who needs an endodontic treatment on a molar tooth - person affiliated to or beneficiary of a social security scheme - patient consent Student: - 4th, 5th or 6th year student in odontology - student consent - student affiliated or beneficiary of a social security scheme Exclusion Criteria: Patients and students: - Pregnant woman - Major protected by law - Non-cooperating person who does not speak or read French fluently, or unable to understand the principle of a stress scale and unable to collaborate on tests. - Person with a psychiatric diagnosis of schizophrenia, delusional disorders and other personality disorders (ICD-10: F20 to F29; DSM IV: Axis II) - Person with a pathology that does not allow interpretation of cardiovascular results (heart rhythm disorders, hypertension) - A person taking medication that affects the heart rate (antiarrhythmics, antihypertensives, beta blockers, etc.). - Refusal to participate - Hearing impaired person who does not perceive sounds correctly - Hearing aid wearer - Person who has already participated in this protocol Patient: - Patient at high risk of infective endocarditis (necrotic pulp) - Patient whose tooth has no functional future and cannot be permanently restored - Patient whose tooth has insufficient periodontal support |
Country | Name | City | State |
---|---|---|---|
France | CHRU de Brest | Brest |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in practitioner's stress during canal root preparation | The student will evaluate his stress on an Analogic Visual Scale (AVS). 0 is "very relax" and 10 is "extremely stressed" | T1bis (preoperative step of the second session of RCT); T4 (canal root preparation) | |
Secondary | Variation of the practitioner's stress at different stages. | The student will evaluate his stress on an Analogic Visual Scale (AVS). 0 is "very relax" and 10 is "extremely stressed". AVS will be compared between each step and the preoperative step of the corresponding session. We will also compare the 3 preoperative steps and the 2 anesthesia steps. | Each step of the RCT | |
Secondary | Variation of the patient's stress at different stages. | The patient will evaluate his stress on an Analogic Visual Scale (AVS). 0 is "very relax" and 10 is "extremely stressed". AVS will be compared between each step and the preoperative step of the corresponding session. We will also compare the 3 preoperative steps and the 2 anesthesia steps. | Each step of the RCT | |
Secondary | Variation of the patient's pain at different stages. | The patient will evaluate his pain on an Analogic Visual Scale (AVS). 0 is "no pain" and 10 is "extremely painful". AVS will be compared between each step and the preoperative step of the corresponding session. We will also compare the 3 preoperative steps and the 2 anesthesia steps. | Each step of the RCT | |
Secondary | Variation of the patient's discomfort at different stages. | The patient will evaluate his discomfort on an Analogic Visual Scale (AVS). 0 is "very comfortable" and 10 is "extremely uncomfortable". AVS will be compared between each step and the preoperative step of the corresponding session. We will also compare the 3 preoperative steps and the 2 anesthesia steps. | Each step of the RCT | |
Secondary | Relation between patient and student's stress | The patient and student will evaluate their stress on an Analogic Visual Scale (AVS). 0 is "very relax" and 10 is "extremely stressed". | Each step of the RCT | |
Secondary | Evaluate the stress induced by an RCT with Spielberger's questionaires | Spielberger's questionnaires Y1 and Y2 for anxiety evaluation will be done on both patients and students to evaluate their general (Y2) and induced (Y1) anxiety. Both questionnaires are composed of 20 questions, total score is between 0 and 80. The higher the score, the more anxious the person is. | Day 0, Day 15, Day 30 | |
Secondary | Dental anxiety | Dental anxiety will be evaluated by the Dental Anxiety Scale of Corah which consist of 4 questions. The total score is calculated between 4 and 20. The highest the score, the more anxious the person is. | Day 0 | |
Secondary | Patient's blood pressure | Patient's systolic and diastolic blood pressure will be evaluated at each stage of the RCT, with a tensiometer (mmHg). This parameter can reflect the stress. | Each step of the RCT | |
Secondary | Patient's heart rate | Patient's heart rate will be evaluated at each stage of the RCT, with a cardiofrequencemeter (number of pulses per minute). This parameter can reflect the patient's stress. | Each step of the RCT | |
Secondary | Patient's heart rate variability | Patient's heart rate variability will be evaluated during the RCT, with a cardiofrequencemeter (ms). This parameter can reflect the patient's stress. | during the RCT (day 0 and day 15) | |
Secondary | Student's blood pressure | Student's systolic and diastolic blood pressure will be evaluated at each stage of the RCT, with a tensiometer (mmHg). This parameter can reflect the stress. | Each step of the RCT | |
Secondary | Student's heart rate | Student's heart rate will be evaluated at each stage of the RCT, with a cardiofrequencemeter (number of pulses per minute). This parameter can reflect the student's stress. | Each step of the RCT | |
Secondary | Student's heart rate variability | Student's heart rate variability will be evaluated during the RCT, with a cardiofrequencemeter (ms). This parameter can reflect the student's stress. | during the RCT (day 0 and day 15) | |
Secondary | Musical training questionnaire | An identical questionnaire for the practitioner and the patient will be filled for the music group. It aims to assess their musical training/knowledge and to evaluate whether a musical training/knowledge has an impact on the effect of the music during the RCT. | Day 0 | |
Secondary | patient's satisfaction assessed by a scale and a questionnaire | The patient will assess his satisfaction on an Analogic Visual Scale (AVS). 0 is "not satisfied" and 10 is "extremely satisfied". The questionnaire aims at determining the sources of satisfaction. | Day 15 | |
Secondary | student's satisfaction assessed by a scale and a questionnaire | The student will assess his satisfaction on an Analogic Visual Scale (AVS). 0 is "not satisfied" and 10 is "extremely satisfied". The questionnaire aims at determining the sources of satisfaction. | Day 15 |
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