Clinical trial NCT06892184: Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry
Official title: Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Communication Skills
Dental Care
Hypnosis
Keywords: Therapeutic communication
Dental care
Induced pain
Nocebo effect
hypnosis
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2025-03-24
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Can we improve our communication to provide better care for our patients? In the healthcare field, the patient's experience is closely linked to pain management. The dental profession often requires simple but invasive procedures, such as local anaesthetics for example, which are providers of discomfort and anxietý that cannot be ignored. Fear of the dentist or dental care is a widespread phenomenon in the general population, since dental anxiety is estimated to affect 36% of the population, and 12% are thought to suffer from extreme fear. Clinicians traditionally warn patients of pain before para-apical anesthesia. This is not surprising, since even today, during initial training for practitioners, patients are taught to be informed, or even warned, of the pain to come, for ethical reasons (i.e., not to lie to the patient) and "so that he/she can prepare for it" (what we will refer to in the remainder of this protocol as classic communication). In the same way as when the patient has acute or induced pain, as is the case here (pain induced by the anesthetic injection), the practitioner also learns to ask if the patient is in pain, and how much. However, the use of pain-related words or a focus on pain can lead to significant anxiety, which in turn lowers the pain threshold. Conversely, the use of positive communication is important, as it can improve the patient's perception of pain and subjective experience. There is a body of literature on the impact of hypnotic communication on pain during painful treatment, but in fields other than dentistry (e.g. venous voice placement - Fusco 2020). To our knowledge, there is no scientific basis on the impact of the type of communication on patient pain in the field of dentistry. If, as we assume, we do indeed find similar results in other fields of medicine, this basis could serve as a basis for modifying the teaching and hence the practice of our young practitioners. We aim to compare the effects of two types of communication (hypnotic and conventional) on patients' pain, comfort and anxiety during para-apical anesthesia in dentistry. Anxiety and comfort were assessed prior to anesthesia on a numerical scale ranging from 0 (no anxiety or comfort) to 10 (greatest imaginable anxiety or comfort). This assessment of anxiety and comfort is asked again after anesthesia has been performed, as well as the pain experienced during anesthesia.


Eligibility criteria: Inclusion Criteria:

* Male or female patient over 18 years of age requiring para-apical anesthesia for dental care.
* Patient informed of the constraints of the study and having given written consent.
* Patient covered by social security.
* Patient with a good command of French.

Exclusion Criteria:

* Pregnant or breastfeeding women, or women who may become pregnant.
* Patients under 18 years of age.
* Patients presenting to the department in an emergency situation (which may increase stress).
* Any medical condition deemed by the investigator to be incompatible with the study.
* Known hypersensitivity to amide-bonded local anesthetics or to any of the excipients.
* Anticoagulant treatment or known blood crase disorders.
* Porphyrias.
* Atrioventricular conduction disorders requiring permanent electrosystolic training not yet performed.
* Epilepsy not controlled by treatment.
* Patient uncooperative, unable to speak or read French fluently, unable to understand the principle of a pain scale, unable to understand the study or unable to sign informed consent.
* Patients under guardianship, curatorship or deprived of liberty.
* Patients premedicated with anxiolytics
* Care requiring anesthesia other than para-apical anesthesia
* Patient highly anxious about dental treatment (Score ≥15 on Corah scale)

Primary outcomes:
measure: pain intensity
timeFrame: assessed just after anesthesia
Secondary outcomes:
measure: Self-assessment of comfort
timeFrame: before and after anesthesia
measure: Self-assessment of anxiety
timeFrame: before and after anesthesia
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Céline Melin
role: PRINCIPAL_INVESTIGATOR
References: