Endodontic DiseaseMUSIQUENDONCT04471558
Effect of Music on Young Practitioner's Stress During Endodontic Treatment
An observational study of Endodontic Disease, run by University Hospital, Brest at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Endodontic Disease
- What is being tested?
- Music
- How many people
- 176 participants
- Where
- 1 siteFrance
- Study dates
- 9 Nov 2020to 9 Dec 2022
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient who needs an endodontic treatment and his practionner.
Who may be able to join
- 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:
Show all 9Show fewer
- 4th, 5th or 6th year student in odontology
- student consent
- student affiliated or beneficiary of a social security scheme
Who cannot join
- 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)
Show all 15Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHRU de Brest
Brest, 29200
CHEVALIER Valérie, MCUPH, valerie.chevalierherisset@univ-brest.fr
LE FUR-BONNABESSE Anaïs, MCU-PH
About this study
Official 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.
Read the 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.
- Conditions
- Endodontic Disease
- Being tested
- Music
- Keywords
- Root canal treatment, Music
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
A part of the RCT will be performed with music in the room. The music will be switch on just before anesthesia and off after the postoperative rest.
| Study group | Role | What they receive |
|---|---|---|
| Music group | A part of the care is realized with music. Receives: Other: Music | |
| Control group | The entire care is realized without music. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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"
Measured: T1bis (preoperative step of the second session of RCT); T4 (canal root preparation)
Secondary outcomes (16)
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.
Measured: Each step of the RCT
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.
Measured: Each step of the RCT
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.
Measured: Each step of the RCT
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.
Measured: Each step of the RCT
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".
Measured: Each step of the RCT
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.
Measured: Day 0, Day 15, Day 30
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.
Measured: Day 0
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.
Measured: Each step of the RCT
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.
Measured: Each step of the RCT
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.
Measured: during the RCT (day 0 and day 15)
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.
Measured: Each step of the RCT
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.
Measured: Each step of the RCT
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.
Measured: during the RCT (day 0 and day 15)
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.
Measured: Day 0
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.
Measured: Day 15
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.
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start9 Nov 2020
- Primary completion9 Dec 2022 (estimated)
- Study completion9 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endodontic DiseaseStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 176 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471558
- Sponsor's protocol ID
- MUSIQUENDO (29BRC20.0045)
- Acronym
- MUSIQUENDO
- Status last verified
- Jan 2021
- First submitted
- 2 Jul 2020
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected data that underlie results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Music on Young Practitioner's Stress During Endodontic Treatment
- ClinicalTrials.gov ID
- NCT04471558
- Acronym / sponsor ID
- MUSIQUENDO / MUSIQUENDO (29BRC20.0045)
- Conditions
- Endodontic Disease
- Keywords
- Root canal treatment, Music
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 9 Nov 2020 (actual)
- Primary completion
- 9 Dec 2022 (estimated)
- Study completion
- 9 Dec 2022 (estimated)
- First posted
- 15 Jul 2020 (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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music group | – | Other: MusicA part of the care is realized with music. |
| Control group | – | –The entire care is realized without music. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient who needs an endodontic treatment and his practionner.
Key inclusion criteria (9 listed)
- 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
- 4th, 5th or 6th year student in odontology
Key exclusion criteria (15 listed)
- 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)
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 |
|---|---|---|
| MusicA part of the RCT will be performed with music in the room. The music will be switch on just before anesthesia and off after the postoperative rest. | Other | Music group |
Primary outcome
Change in practitioner's stress during canal root preparation
Time frame: T1bis (preoperative step of the second session of RCT); T4 (canal root preparation)
The student will evaluate his stress on an Analogic Visual Scale (AVS). 0 is "very relax" and 10 is "extremely stressed"
16 secondary outcomes
Variation of the practitioner's stress at different stages.
Time frame: Each step of the RCT
Variation of the patient's stress at different stages.
Time frame: Each step of the RCT
Variation of the patient's pain at different stages.
Time frame: Each step of the RCT
Variation of the patient's discomfort at different stages.
Time frame: Each step of the RCT
Relation between patient and student's stress
Time frame: Each step of the RCT
Evaluate the stress induced by an RCT with Spielberger's questionaires
Time frame: Day 0, Day 15, Day 30
Dental anxiety
Time frame: Day 0
Patient's blood pressure
Time frame: Each step of the RCT
Patient's heart rate
Time frame: Each step of the RCT
Patient's heart rate variability
Time frame: during the RCT (day 0 and day 15)
Student's blood pressure
Time frame: Each step of the RCT
Student's heart rate
Time frame: Each step of the RCT
Student's heart rate variability
Time frame: during the RCT (day 0 and day 15)
Musical training questionnaire
Time frame: Day 0
patient's satisfaction assessed by a scale and a questionnaire
Time frame: Day 15
student's satisfaction assessed by a scale and a questionnaire
Time frame: Day 15
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
- Individual participant dataSharing planned: Yes. All collected data that underlie results in a publication.
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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.
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 Disease, 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 9 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 27 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact CHEVALIER Valérie, MCU-PH (0298223330, valerie.chevalierherisset@univ-brest.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in practitioner's stress during canal root preparation (time frame: T1bis (preoperative step of the second session of RCT); T4 (canal root preparation)). 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 27 Jan 2021.