Respiratory DisorderAVATARNCT05973201
Evaluation of Virtual Reality to Reduce Anxiety, Pain and Duration of Non-emergency Vigile Bronchial Fibroscopy (AVATAR)
A study testing Virtual reality headset in people with Respiratory Disorder and Lung Infection, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.
Trial summary
Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Disorder, Lung Infection
- What is being tested?
- Virtual reality headset
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 5 sitesFrance
- Study dates
- 19 Oct 2023to 26 Oct 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Adults (over 18 years of age)
- Hospitalized in a critical care unit (intensive care and intensive care)
- Conscious (Glasgow score >13)
- Spontaneous ventilation
- Requiring the realization of a FB
- First BF during hospitalization
- Having signed a consent to participate in the study
- Affiliation to social security
Who cannot join
- Non-French-speaking patient
- Protected minors or adults who cannot consent to participate
- People with major neurocognitive impairment
- Patient refusing to participate in the study
- Patient on State medical aid
- Patient under guardianship or curatorship or under judicial protection
Show all 17Show fewer
- BF for a vital emergency
- Prior inclusion in the study
- Pregnant or breastfeeding women
- Presence of a tracheostomy or tracheostomy
- Participation in other intervention research
- Epilepsy
- Visual impairment (blindness) or severe hearing impairment (hearing loss, deafness) that does not allow the use of the helmet
- Psychiatric pathologies such as delusional disorders, hallucinations or schizophrenia.
- Autism spectrum disorders
- Patient sensitive to motion sickness
- Refractory migraine under treatment
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites, 4 recruiting
- Recruiting
CHI Aix en Provence
Aix-en-Provence, 13100
Youssef TRIGUI, MD, +334 42 33 90 33, ytrigui@ch-aix.fr
Youssef TRIGUI, MD
- Recruiting
CHU Dijon
Dijon, 21079
Marjolaine GEORGES, MD, +333 80 29 37 72, marjolaine.georges@chu-dijon.fr
Marjolaine GEORGES, MD
- Withdrawn
Hôpital Le Kremlin Bicêtre
Le Kremlin-Bicêtre, 94270
- Recruiting
Hôpital européen Georges Pompidou - AP-HP
Paris, 75015
Alexandra GOMES, Nurse, +331 56 09 25 64, alexandra.gomes@aphp.fr
Anaïs RASTELLO, Nurse
- Not yet recruiting
Hôpital Foch
Suresnes, 92150
Floriane Costani, Nurse, +33 1 46 25 29 07, f.costani@hopital-foch.com
Floriane Costani, Nurse
About this study
Official title: Evaluation De La Réalité Virtuelle Pour Réduire L'anxiété, La Douleur Et De La Durée D'une Fibroscopie Bronchique Vigile Non Urgente En Soins Critiques
Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. The good tolerance of the examination and its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce pain and anxiety during first pathways placement or digestive endoscopies. To date, there is no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.
Read the detailed description
Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients under local anesthesia very regularly performed in patients hospitalized in critical care. Despite local anesthesia, and paradoxically also because of local anesthesia that makes the airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and in response to patients' discomfort or anxiety. We believe that a preventive, non-drug strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis, music therapy or virtual reality. Hypnosis requires the availability of previously trained caregivers and a calm environment. Music therapy is difficult to apply in IS because of pre-existing noise pollution. We hypothesize that virtual reality would reduce patient anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and caregiver experience and optimize its realization. Virtual reality (VR) is a technology that allows the patient to be projected, via a computer system, into an immersive virtual world. The patient's immersion in the virtual environment is accompanied by the feeling of "presence" which can be defined as the authentic feeling of existing in a world other than the one where the body is physically located.This specificity, coupled with the ability to isolate the patient's visual and auditory field, make this tool a promising solution to improve the well-being of patients during the care offer. VR is distributed by a set of devices to digitally simulate an environment mobilizing the different senses of its user: sight most often but possibly also touch, hearing or smell. VR, most often distributed via video and audio headset, is a complete immersive experience that can bring together hypnotic scenario and music therapy.
HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic and anxiolytic actions through specific virtual environments by combining different principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The proposed immersion themes combined with breathing exercises in the initial phase, generate better stress management.
- Conditions
- Respiratory Disorder, Lung Infection
- Being tested
- Virtual reality headset
- Keywords
- Virtual reality, Pulmonary fibroscopy, Anxiety, Pain, Intensive care
- Medical subject headings
- Respiration Disorders, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality headsetDevice
A HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet.
The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic).
| Study group | Role | What they receive |
|---|---|---|
| interventional arm | Experimental | Fibroscopy performed under local anesthesia with immersion in a virtual reality scenario Receives: Device: Virtual reality headset |
| Conventional arm | No intervention | Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
Measured: Immediately after BF
Secondary outcomes (13)
The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)
The Spielberger State-Trait Anxiety Inventory (STAI) is a 40-item self-report measure of anxiety using a 4-point Likert-type scale (from 1 to 4 points) for each item. It has two scales: State anxiety, i.e. how one feels at the moment; and Trait anxiety, i.e. how one generally feels. Both scales consist of 20 items. The state scale has 10 reverse-scored items, the trait scale has 7. Scores of both scales ranges from 20 to 80.
Measured: Immediately after BF
Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)
The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
Measured: When leaving the intensive care unit or on the 7th day at the latest, post BF
Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB
The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of pain" and the other to "maximum pain imaginable". The patient must then place the cursor where he locates his pain. VAS ranges from 0 to 100 mm.
Measured: Immediately after BF
Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB
The ALGOPLUS scale was specifically developed to evaluate and manage acute pain in the elderly in all situations in which reliable self-assessment is not feasible. The scale is composed of 5 items (observational areas/domains). Each item checked "yes" is accorded 1 point and the sum of checked items gives a total score ranging from 1 to 5.
Measured: Immediately after BF
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
Measured: Immediately after BF
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
Measured: Immediately after BF
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
Measured: Immediately after BF
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
Measured: Immediately after BF
Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR
The questionnaire items lists the side effects of the VR (8 items with 3 answer categories: yes, no and do not know).
Measured: 1 day post BF
Patient anxiety experienced before BF evaluated by the nursing staff assessed by Hamilton scale
The Hamilton Anxiety Rating Scale (HAM-A) is a psychological questionnaire used by clinicians to rate the severity of a patient\'s anxiety.The scale consists of 14 items designed to assess the severity of a patient\'s anxiety.
Measured: Before BF
The total dose of sedative and anxiolytic drugs administered during BF
The total dose of midazolam, alprazolam, hydroxyzine, diprivan, stage II or III analgesics administered during BF
Measured: Immediately after BF
The quality of FB (specific questionnaire completed by the physician describing the quality of exploration, the possibility of taking samples and the satisfaction VAS).
A specific questionnaire completed by the physician in charge of the BF will be used describing the quality of the exploration and the possibility of taking samples
Measured: Immediately after BF
Remote patient satisfaction with FB measured using the e-SATIS ?questionnaire (Haute Autorité de Santé "prise en charge" section), and the answer to the single question: "Would you have a bronchial fibroscopy again in the future)
E-SATIS is an experience and satisfaction questionnaire, in which all patients are invited to participate, following treatment in a health establishment, hospital or clinic. The questionnaire is validated by the French Haute autorité de santé. The \"patient care\" section of the questionnaire was used to assess remote patient\'s satisfaction on the BF procedure. For each responding patient, a score ranging from 1 [bad experience] to 5 [excellent experience] (transformed into a value from 0 to 100) is given to each of his answers.
Measured: 7 days post BF
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start19 Oct 2023
- Primary completion19 Oct 2025 (estimated)
- Study completion26 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory DisorderStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF. The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)\].
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, France
- Responsible party
- Sponsor
- Investigators
- Alexandra GOMES, Nurse, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05973201
- Sponsor's protocol ID
- APHP220834
- Other IDs
- PHRIP-21-0055, 2023-A00163-42
- Acronym
- AVATAR
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation De La Réalité Virtuelle Pour Réduire L'anxiété, La Douleur Et De La Durée D'une Fibroscopie Bronchique Vigile Non Urgente En Soins Critiques
- ClinicalTrials.gov ID
- NCT05973201
- Acronym / sponsor ID
- AVATAR / APHP220834
- Conditions
- Respiratory Disorder, Lung Infection
- Keywords
- Virtual reality, Pulmonary fibroscopy, Anxiety, Pain, Intensive care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Ministry of Health, France
- Study start
- 19 Oct 2023 (actual)
- Primary completion
- 19 Oct 2025 (estimated)
- Study completion
- 26 Oct 2025 (estimated)
- First posted
- 2 Aug 2023 (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.
Bronchial fibroscopy (BF) is a routine practice examination in critical care areas. It can be useful either for the diagnosis of the causal pathology of respiratory distress or for the diagnosis of lung infection, sometimes nosocomial. In patients in spontaneous and conscious ventilation, BF are performed vigil after local anesthesia according to the recommendations of the Société de Pneumologie de langue Française. The good tolerance of the examination and its good conduct may require the use of anxiolytics, sedatives or analgesics to limit the traumatic experience of a highly anxiety-provoking examination. Virtual reality (VR) combines a set of paramedical techniques (hypnosis, music therapy, sophrology) and is now a non-drug alternative to improve the tolerance of certain invasive gestures.VR has been shown to reduce pain and anxiety during first pathways placement or digestive endoscopies. To date, there is no evidence of the benefit of VR when performing semi-urgent BF in critical care areas.
Detailed description
Bronchial fibroscopy (BF) is an invasive examination mainly performed in vigilant patients under local anesthesia very regularly performed in patients hospitalized in critical care. Despite local anesthesia, and paradoxically also because of local anesthesia that makes the airflow in the upper airway imperceptible, BF is an anxiety-provoking and sometimes uncomfortable examination. Drug options are offered by physicians on a case-by-case basis and in response to patients' discomfort or anxiety. We believe that a preventive, non-drug strategy would improve comfort, reduce anxiety and improve patients' experience during BF. To reduce anxiety and improve patient comfort, there are non-drug alternatives such as hypnosis, music therapy or virtual reality. Hypnosis requires the availability of previously trained caregivers and a calm environment. Music therapy is difficult to apply in IS because of pre-existing noise pollution. We hypothesize that virtual reality would reduce patient anxiety during a bronchial fibroscopy in bed in critical care, improve the patient and caregiver experience and optimize its realization. Virtual reality (VR) is a technology that allows the patient to be projected, via a computer system, into an immersive virtual world. The patient's immersion in the virtual environment is accompanied by the feeling of "presence" which can be defined as the authentic feeling of existing in a world other than the one where the body is physically located.This specificity, coupled with the ability to isolate the patient's visual and auditory field, make this tool a promising solution to improve the well-being of patients during the care offer. VR is distributed by a set of devices to digitally simulate an environment mobilizing the different senses of its user: sight most often but possibly also touch, hearing or smell. VR, most often distributed via video and audio headset, is a complete immersive experience that can bring together hypnotic scenario and music therapy.
HEALTHY MIND® has designed a VR headset to relieve pain and anxiety in patients in healthcare facilities in a non-drug way. Indeed, this helmet has been developed to exercise analgesic and anxiolytic actions through specific virtual environments by combining different principles such as medical hypnosis, music therapy, light therapy and cardiac coherence. The proposed immersion themes combined with breathing exercises in the initial phase, generate better stress management.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients in whom elective BF has been scheduled and who have given consent to the study will be randomised (1:1) to either the control group (BF after local anaesthesia (LA)) or the experimental group (BF after AL and VR immersion). Randomization will be done 30 minutes before BF, after an initial assessment of anxiety (pre-BF VAS) and will be stratified according to whether or not a psychotropic drug and/or a level II analgesic is taken the day before or on the day of BF. The randomization list will be programmed in advance by the study statistician using SAS software and will be generated and edited by another statistician independent of the study from the HEGP clinical research unit. The randomization list will be kept by the study sponsor (AP-HP). It will be available to users via web-based software (CleanWeb software (Telemedicine Technologies, http: //www.tentelemed.com/la-solution-cleanweb/)].
| Arm | Type | Receives |
|---|---|---|
| interventional arm | Experimental | Device: Virtual reality headsetFibroscopy performed under local anesthesia with immersion in a virtual reality scenario |
| Conventional arm | No intervention | –Fibroscopy performed under local anesthesia without immersion in a virtual reality scenario |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (over 18 years of age)
- Hospitalized in a critical care unit (intensive care and intensive care)
- Conscious (Glasgow score >13)
- Spontaneous ventilation
- Requiring the realization of a FB
Key exclusion criteria (17 listed)
- Non-French-speaking patient
- Protected minors or adults who cannot consent to participate
- People with major neurocognitive impairment
- Patient refusing to participate in the study
- Patient on State medical aid
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 |
|---|---|---|
| Virtual reality headsetA HEALTHY MIND® brand VR headset is dedicated to the study. The kit includes a noise-reducing audio headset, a face mask diffusing the visual part, a touchscreen tablet connected to the two VR headset systems, and a microphone connected to the tablet. The available software allows patients to choose between 5 natural environments in which a hypnotic speech is broadcast, available in several languages (French, English, Spanish, Russian, Arabic). | Device | interventional arm |
Primary outcome
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF
Time frame: Immediately after BF
The visual analogue scale is a rating scale in the form of a 10 cm strip graduated in mm that can be presented horizontally or vertically. On the face presented to the patient, there is a cursor that he mobilizes on a straight line with one end corresponding to "absence of anxiety" and the other to "maximum anxiety imaginable". The patient must then place the cursor where he locates his anxiety. VAS ranges from 0 to 100 mm.
13 secondary outcomes
The relative change of patient's anxiety before and after BF assessed by the STAI-A scale (state anxiety scale)
Time frame: Immediately after BF
Patient's anxiety when leaving the intensive care unit (or on the 7th day at the latest, after BF) assessed by the visual analogue scale (VAS)
Time frame: When leaving the intensive care unit or on the 7th day at the latest, post BF
Maximum value of patient's pain experienced during BF assessed by the visual analogue scale (VAS) immediately after the FB
Time frame: Immediately after BF
Patient's pain experienced during BF evaluated by the nursing staff assessed by the ALGOPLUS scale immediately after the FB
Time frame: Immediately after BF
The relative change of patient's maximum pulse measured during BF compared to pulse measured before BF
Time frame: Immediately after BF
The relative change of patient's maximum respiratory rate measured during BF compared to respiratory rate measured before BF
Time frame: Immediately after BF
The relative change of patient's maximum blood pressure measured during BF compared to blood pressure measured before BF
Time frame: Immediately after BF
The duration of BF (in minutes) from the start of the local anesthesia to the permanent removal of the fibroscopy
Time frame: Immediately after BF
Tolerance to the VR assessed by a questionnaire measuring the side effects of the VR
Time frame: 1 day post BF
Patient anxiety experienced before BF evaluated by the nursing staff assessed by Hamilton scale
Time frame: Before BF
The total dose of sedative and anxiolytic drugs administered during BF
Time frame: Immediately after BF
The quality of FB (specific questionnaire completed by the physician describing the quality of exploration, the possibility of taking samples and the satisfaction VAS).
Time frame: Immediately after BF
Remote patient satisfaction with FB measured using the e-SATIS ?questionnaire (Haute Autorité de Santé "prise en charge" section), and the answer to the single question: "Would you have a bronchial fibroscopy again in the future)
Time frame: 7 days post BF
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie results in publication could be shared. IPD detailed in the protocol of a planned metaanalysis could be shared
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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. This study is not recruiting at the moment.
Alexandra GOMES, Nurse principal investigator
Assistance Publique - Hôpitaux de Paris
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality headset in people with Respiratory Disorder and Lung Infection, run by Assistance Publique - Hôpitaux de Paris at 5 sites 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 8 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 4 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aurélie ZINDJIRDJIAN (+33 1 44 84 17 64, aurelie.zindjirdjian@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum value of patient's anxiety experienced during BF assessed by the visual analogue scale (VAS) immediately after the BF (time frame: Immediately after BF). 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 4 Dec 2024.