Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry (CADA)

Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry: Randomized Clinical Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Hypnosis; Communication Skills; Dental Care
• Intervention / Treatment: Behavioral: hypnotic communication; Behavioral: conventional communication

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lise Laclautre; Phone Number: 334.73.754.963; Email: promo_interne_drci@chu-clermontferrand.fr

Study Locations

• France
  • Clermont-Ferrand, France
    • Recruiting
    • CHU de Clermont-Ferrand
    • Contact: Lise Laclautre
    • Principal Investigator: Céline Melin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hypnotic communication	Behavioral: hypnotic communication; During local anaesthesia, the operator will not remain silent, nor will he describe to his patient the anaesthesia he is performing, nor warn his patient of possible future pain. When performing anesthesia, the operator will use a dissociative, hypnotic language, standardized across all patients.
Active Comparator: conventional communication	Behavioral: conventional communication; suggestions typically uttered by the practitioner, who describes what he is doing and warns of possible pain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	Perception of pain experienced by the patient during anesthesia, assessed after anesthesia by numerical scale from 0 to 10.	assessed just after anesthesia

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-assessment of comfort	numerical scale from 0 to 10	before and after anesthesia
Self-assessment of anxiety	numerical scale from 0 to 10	before and after anesthesia

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Investigators: Principal Investigator: Céline Melin, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 21, 2025
• First Posted (Actual): March 24, 2025

Study Record Updates

• Last Update Posted (Actual): August 11, 2025
• Last Update Submitted That Met QC Criteria: August 8, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: hypnosis; Nocebo effect; Therapeutic communication; Dental care; Induced pain
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Hypnotics and Sedatives
• Other Study ID Numbers: RBHP 2024 MELIN (CADA); 2024-A02606-41 (Other Identifier: 2024-A02606-41)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No