Clinical trial NCT04471558: Effect of Music on Young Practitioner's Stress During Endodontic Treatment
Official title: Evaluation of the Effect of Music on Young Practitioner's Stress During Endodontic Treatment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Endodontic Disease
Keywords: Root canal treatment
Music
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2020-07-15
Enrollment: 176
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient who needs an endodontic treatment and his practionner.

Brief summary: 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.

Detailed description: Root canal treatment (RCT) consists in eliminating infected and /or inflammatory tissues inside the root canal system of the tooth by a chemo-mechanical preparation and then filling the latter in a three-dimensional, bacteriostatic and durable way to enable healing. This treatment is commonly carried out and can sometimes be long and tedious, as, for instance, on molars with several roots.

According to numerous studies, patients consider endodontic treatment as one of the most stress-inducing dental procedures. The preliminary study Stressendo has shown that anesthesia is the most stressful step for the patient. In some studies, patients also fear the pain and discomfort during RCT. Stress and pain have neurological consequences including the activation of neuroendocrine system which secretes catecholamines. Those act on the heart by increasing the heart rate and arterial pressure.

Two studies demonstrated that relaxing music enables the patient to be less stressed during RCT.

Another study has shown that music also enables the patient to feel less painful during dental care. This would be explained by the fact that music can help reducing the sound perceived as stressful for the patients, in addition to the distraction it produces. Music also has a physiological and psychological role, which enables the patient to feel more relaxed. However, it would depend on its style and the fact that the patient likes it or not. Many studies demonstrated that when the patient likes the music used, the reduction of anxiety is higher than with relaxing music.

RCTs are stressful for the patient, but one must keep in mind that it is also stressful for the practitioner, and particularly for students who start their dental practice.

The students have to treat patients with many parameters to manage. Combining theoretical and clinical practice knowledge is difficult and stressful for students according to a study. 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 obturation.

The beneficial side of listening to music (relaxing music) on the patient's stress during RCT has been proved; but to our knowledge, no study assessed the effect of listening to appreciated music on the stress of the practitioner and more particularly of the young practitioner, during endodontic treatment and in particular root canal preparation.This is the main aim of this study.

Eligibility criteria: 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

Primary outcomes:
measure: Change in practitioner's stress during canal root preparation
timeFrame: T1bis (preoperative step of the second session of RCT); T4 (canal root preparation)
Secondary outcomes:
measure: Variation of the practitioner's stress at different stages.
timeFrame: Each step of the RCT
measure: Variation of the patient's stress at different stages.
timeFrame: Each step of the RCT
measure: Variation of the patient's pain at different stages.
timeFrame: Each step of the RCT
measure: Variation of the patient's discomfort at different stages.
timeFrame: Each step of the RCT
measure: Relation between patient and student's stress
timeFrame: Each step of the RCT
measure: Evaluate the stress induced by an RCT with Spielberger's questionaires
timeFrame: Day 0, Day 15, Day 30
measure: Dental anxiety
timeFrame: Day 0
measure: Patient's blood pressure
timeFrame: Each step of the RCT
measure: Patient's heart rate
timeFrame: Each step of the RCT
measure: Patient's heart rate variability
timeFrame: during the RCT (day 0 and day 15)
measure: Student's blood pressure
timeFrame: Each step of the RCT
measure: Student's heart rate
timeFrame: Each step of the RCT
measure: Student's heart rate variability
timeFrame: during the RCT (day 0 and day 15)
measure: Musical training questionnaire
timeFrame: Day 0
measure: patient's satisfaction assessed by a scale and a questionnaire
timeFrame: Day 15
measure: student's satisfaction assessed by a scale and a questionnaire
timeFrame: Day 15
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
References: