HypnosisHYPNOFACENCT03926403
Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia
A study testing State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), hypnosis techniques and local anaesthesia in people with Hypnosis and Local Anaesthesia, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypnosis, Local Anaesthesia, Outpatient Surgery
- What is being tested?
- State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), hypnosis techniques and local anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to Oct 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient treated under local anaesthesia in the Maxillo Facial Surgery department with ultra-short circuit
- Patient undergoing face surgery
- Patient who has received appropriate information and has provided informed consent
- Adult patient ≥ 18 years old
- Patient with a score of ≥ 36 on the initial anxiety self-assessment questionnaire
Who cannot join
- Patient under general anaesthesia
- Patients treated in conventional inpatient care or in the traditional ambulatory circuit
- Patient under guardianship or trusteeship
- Minor patient < 18 years of age
- Patient who has not provided informed consent or who cannot submit to the study protocol
- Patient suffering from cognitive disorders (ex: Alzheimer's disease)
- Patients who are deaf or hearing-impaired
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 Amiens Picardie
Amiens, 80000
Stéphanie DAKPE, MD, dakpe.stéphanie@chu-amiens.fr
About this study
Official title: Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.
Read the detailed description
Interventions performed under local anaesthesia may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. Hypnosis in particular has long been used in the non-pharmacological management of pain and anxiety.
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will be informed of the study in consultation by the maxillofacial surgeon. If they give their informed consent, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") will be given to them and collected on the same day. Each patient's anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.
- Conditions
- Hypnosis, Local Anaesthesia, Outpatient Surgery, FACE
- Being tested
- State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), hypnosis techniques, local anaesthesia
- Keywords
- hypnosis, local anaesthesia, outpatient surgery, face surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")Other
Patients will be given, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") that will be collected on the same day. Each patient's initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36).
hypnosis techniquesProcedure or surgery
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
local anaesthesiaProcedure or surgery
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis | Experimental | Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques. Receives: Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"); Procedure: hypnosis techniques |
| conventional management | Active comparator | Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia). Receives: Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"); Procedure: local anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure
The State-Trait Anxiety Inventory (STAI) (or Spielbergers's anxiety self-assessment questionnaire) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
Measured: on the day of surgery under local anaesthesia.
Secondary outcomes (3)
Value reported by the patient on the Visual Analogue Pain Scale after surgery
The visual analogue scale (VAS) is commonly used as the outcome measure. It is usually presented as a 100-mm horizontal line on which the patient's pain intensity is represented by a point between the extremes of "no pain at all" and "worst pain imaginable."
Measured: on the day of surgery under local anaesthesia.
Variation of amount of local anaesthetic
Amount of local anaesthetic consumed for a defined surgical procedure
Measured: on the day of surgery under local anaesthesia.
measure of operating time
operating time for a defined surgical procedure.
Measured: on the day of surgery under local anaesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2019
- Study start28 Jan 2020
- Primary completionJul 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 66 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bernard Devauchelle, Pr, Principal investigator, CHU AmiensStéphanie Dakpe, MD, Principal investigator, CHU AmiensSylvie Testelin, Pr, Principal investigator, CHU AmiensJérémie Bettoni, MD, Principal investigator, CHU AmiensStéphanie Mauquit, N, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03926403
- Sponsor's protocol ID
- PI2019_843_0007
- Acronym
- HYPNOFACE
- Status last verified
- May 2026
- First submitted
- 16 Apr 2019
- Last updated
- 13 May 2026
- 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 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Hypnosis Support on Patient Perception of Outpatient Surgery Under Local Anaesthesia in the Maxillo-Facial Surgery Department of the CHU Amiens-Picardie.
- ClinicalTrials.gov ID
- NCT03926403
- Acronym / sponsor ID
- HYPNOFACE / PI2019_843_0007
- Conditions
- Hypnosis, Local Anaesthesia, Outpatient Surgery, FACE
- Keywords
- hypnosis, local anaesthesia, outpatient surgery, face surgery
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 66 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 24 Apr 2019 (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.
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
The purpose of this study is to evaluate the effectiveness of hypnosis support on the patient's state of anxiety before and after outpatient surgery under local anaesthesia in the Maxillofacial Surgery Department.
Detailed description
Interventions performed under local anaesthesia may be a particular source of anxiety for some patients, and the management of surgical pain is still a real challenge. In order to avoid the side effects of medications, a lot of caregivers are turning to complementary medicines. Hypnosis in particular has long been used in the non-pharmacological management of pain and anxiety.
Many clinical trials assessing the effectiveness of hypnosis have been conducted in recent years, some of which show that hypnosis reduces pain perception better than drug treatments administered to control groups, and that it is at least as effective as other complementary therapies (such as massage, acupuncture, yoga). However, their conclusions are limited by a significant risk of bias, and further studies with rigorous methodology remain necessary. The hypothesis of this study is that hypnosis support methods can reduce anxiety in patients requiring facial surgery under local anaesthesia, and thus improve their medical management.
Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will be informed of the study in consultation by the maxillofacial surgeon. If they give their informed consent, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") will be given to them and collected on the same day. Each patient's anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). The latter will be randomized into 2 groups, one benefiting from experimental management based on hypnosis techniques and the other benefiting from conventional management.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis | Experimental | Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), Procedure: hypnosis techniquesPatients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques. |
| conventional management | Active comparator | Other: State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), Procedure: local anaesthesiaPatients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient treated under local anaesthesia in the Maxillo Facial Surgery department with ultra-short circuit
- Patient undergoing face surgery
- Patient who has received appropriate information and has provided informed consent
- Adult patient ≥ 18 years old
- Patient with a score of ≥ 36 on the initial anxiety self-assessment questionnaire
Key exclusion criteria (7 listed)
- Patient under general anaesthesia
- Patients treated in conventional inpatient care or in the traditional ambulatory circuit
- Patient under guardianship or trusteeship
- Minor patient < 18 years of age
- Patient who has not provided informed consent or who cannot submit to the study protocol
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 |
|---|---|---|
| State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire")Patients will be given, a State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire") that will be collected on the same day. Each patient's initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36). | Other | Hypnosis, conventional management |
| hypnosis techniquesPatients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques. | Procedure or surgery | Hypnosis |
| local anaesthesiaPatients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia). | Procedure or surgery | conventional management |
Primary outcome
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure
Time frame: on the day of surgery under local anaesthesia.
The State-Trait Anxiety Inventory (STAI) (or Spielbergers's anxiety self-assessment questionnaire) is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. The STAI measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic. Higher scores are positively correlated with higher levels of anxiety.
3 secondary outcomes
Value reported by the patient on the Visual Analogue Pain Scale after surgery
Time frame: on the day of surgery under local anaesthesia.
Variation of amount of local anaesthetic
Time frame: on the day of surgery under local anaesthesia.
measure of operating time
Time frame: on the day of surgery under local anaesthesia.
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 13 May 2026.
- 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.
Bernard Devauchelle, Pr principal investigator
CHU Amiens
Stéphanie Dakpe, MD principal investigator
CHU Amiens
Sylvie Testelin, Pr principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing State-Trait Anxiety Inventory ("Spielberger Self-Assessment Questionnaire"), hypnosis techniques and local anaesthesia in people with Hypnosis and Local Anaesthesia, run by Centre Hospitalier Universitaire, Amiens 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 5 inclusion and 7 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 13 May 2026. 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 Martine Gosset, ORN ((33)322089050, gosset.martine@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
variation in Spielberger's anxiety self-assessment questionnaire score between the patient's arrival in the operating room and his departure (time frame: on the day of surgery under local anaesthesia.). 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 13 May 2026.