Communication SkillsCADANCT06892184
Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry
A study testing hypnotic communication and conventional communication in people with Communication Skills and Dental Care, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Communication Skills, Dental Care, Hypnosis
- What is being tested?
- hypnotic communication and conventional communication
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteFrance
- Study dates
- 13 May 2025to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Clermont-Ferrand
Clermont-Ferrand
Lise Laclautre
Céline Melin
About this study
Official title: 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.
- Conditions
- Communication Skills, Dental Care, Hypnosis
- Being tested
- hypnotic communication, conventional communication
- Keywords
- Therapeutic communication, Dental care, Induced pain, Nocebo effect, hypnosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypnotic communicationBehavioural
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.
conventional communicationBehavioural
suggestions typically uttered by the practitioner, who describes what he is doing and warns of possible pain.
| Study group | Role | What they receive |
|---|---|---|
| hypnotic communication | Experimental | Not described Receives: Behavioral: hypnotic communication |
| conventional communication | Active comparator | Not described Receives: Behavioral: conventional communication |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
Perception of pain experienced by the patient during anesthesia, assessed after anesthesia by numerical scale from 0 to 10.
Measured: assessed just after anesthesia
Secondary outcomes (2)
Self-assessment of comfort
numerical scale from 0 to 10
Measured: before and after anesthesia
Self-assessment of anxiety
numerical scale from 0 to 10
Measured: before and after anesthesia
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start13 May 2025
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Communication SkillsStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline Melin, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892184
- Sponsor's protocol ID
- RBHP 2024 MELIN (CADA)
- Other IDs
- 2024-A02606-41
- Acronym
- CADA
- Status last verified
- Aug 2025
- First submitted
- 18 Mar 2025
- Last updated
- 11 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Importance of the Type of Communication Used During Paraapical Anesthesia in Dentistry: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06892184
- Acronym / sponsor ID
- CADA / RBHP 2024 MELIN (CADA)
- Conditions
- Communication Skills, Dental Care, Hypnosis
- Keywords
- Therapeutic communication, Dental care, Induced pain, Nocebo effect, hypnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 13 May 2025 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 24 Mar 2025 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hypnotic communication | Experimental | Behavioral: hypnotic communication |
| conventional communication | Active comparator | Behavioral: conventional communication |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 |
|---|---|---|
| hypnotic communicationDuring 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. | Behavioural | hypnotic communication |
| conventional communicationsuggestions typically uttered by the practitioner, who describes what he is doing and warns of possible pain. | Behavioural | conventional communication |
Primary outcome
pain intensity
Time frame: assessed just after anesthesia
Perception of pain experienced by the patient during anesthesia, assessed after anesthesia by numerical scale from 0 to 10.
2 secondary outcomes
Self-assessment of comfort
Time frame: before and after anesthesia
Self-assessment of anxiety
Time frame: before and after anesthesia
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
- Individual participant dataSharing planned: No
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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.
Céline Melin principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypnotic communication and conventional communication in people with Communication Skills and Dental Care, run by University Hospital, Clermont-Ferrand 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 4 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (time frame: assessed just after anesthesia). 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 11 Aug 2025.