NCT04471558

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 15, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

November 9, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2022

Completed
Last Updated

January 27, 2021

Status Verified

January 1, 2021

Enrollment Period

2.1 years

First QC Date

July 2, 2020

Last Update Submit

January 25, 2021

Conditions

Keywords

Root canal treatmentMusic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (16)

  • Variation of the practitioner's stress at different stages.

    Each step of the RCT

  • Variation of the patient's stress at different stages.

    Each step of the RCT

  • Variation of the patient's pain at different stages.

    Each step of the RCT

  • Variation of the patient's discomfort at different stages.

    Each step of the RCT

  • Relation between patient and student's stress

    Each step of the RCT

  • +11 more secondary outcomes

Study Arms (2)

Music group

A part of the care is realized with music.

Other: Music

Control group

The entire care is realized without music.

Interventions

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.

Music group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patient who needs an endodontic treatment and his practionner.

You may qualify if:

  • 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:
  • th, 5th or 6th year student in odontology
  • student consent
  • student affiliated or beneficiary of a social security scheme

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29200, France

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Central Study Contacts

CHEVALIER Valérie, MCU-PH

CONTACT

LE FUR BONNABESSE Anais, MCU-PH

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2020

First Posted

July 15, 2020

Study Start

November 9, 2020

Primary Completion

December 9, 2022

Study Completion

December 9, 2022

Last Updated

January 27, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication.

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning three years and ending five years following the final study report completion.
Access Criteria
Data access request will be reviewed by the internal committee of Brest University Hospital. Requestor will be required to sign and complete a data access agreement.

Locations