- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06016582
Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer (Hypno-TEC)
Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Hypno-TEC Feasibility Study
Assisted Reproduction Technology (ART) procedures are often long and particularly stressful for couples. The level of anxiety appears to persist throughout the entire process, particularly during embryo transfer, a pivotal and delicate stage in In Vitro Fertilization (IVF). Many women apprehend this maneuver, firstly, as it represents the culmination of the process and consequently elicits apprehensions regarding negative outcome, and secondly, as it instigates anxiety related to potential discomfort during the procedure.
Medical Hypnosis in Virtual Reality is a combination of hypnotherapy and immersion in a fictitious world, used in the medical field for anxiolytic and analgesic purposes. This fusion is made possible by a virtual reality headset coupled with an auditory device.
The diversion and relaxation conferred by this device can lead to a reduction in perceived anxiety and an indirect enhancement of compliance and cooperation during medical procedure. Several studies have already demonstrated a benefit on pre-operative and peri-operative anxiety, with reassuring safety data on the use of this medical device.
However, despite the common use of VRH in the medical field, encouraging data on anxiety reduction, and accessibility to these headsets within in certain ART departments, they are not routinely employed during embryo transfers. Various barriers to the implementation of this medical device in this indication seem to be present, encompassing organizational, technical, and practical aspects.
Consequently, the Hypno-TEC study aims to assess the feasibility of using virtual reality hypnosis (VRH) headset for anxiolytic purposes during frozen embryo transfer (FET).
Hypno-TEC will be a prospective interventional study, not comparative, and conducted at a single center, within the Reproductive Medicine Department of the Mother-Child-Woman Hospital in Lyon. This clinical investigation will fall under category 4.2 of medical device regulations, according to European Regulation 2017/745.
The enrolled patients, estimated to be 50 in number, will benefit from the device (VRH headset) during the execution of the FET procedure.
Besides assessing the feasibility of this usage, secondary outcomes will include: (i) evaluating the procedure's acceptability, (ii) patient and caregiver satisfaction with this application, (iii) effect on patient anxiety, and (iv) the pregnancy rates following the transfers concerned by the study.
The expected benefit is the potential to incorporate these headsets into routine practice, thereby would be enhancing patient adherence and tolerance to the transfer procedure.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhône
-
Bron, Rhône, France, 69500
- Hôpital Femme Mère Enfant
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female patient aged between 18 and 45
- Currently undergoing In Vitro Fertilization treatment at the Assisted Reproduction Unit of the Mother-Child-Woman Hospital in Lyon
- Having a frozen embryo transfer planned, and for which the companion plans to be present
- Having signed an informed consent form
- Affiliated with the French social security system
- Understanding the French language, both spoken and written
Exclusion Criteria:
- Unbalanced epilepsy
- Patients with psychiatric disorders documented in their medical records
- Visual impairments preventing use of virtual reality (lack of binocular vision)
- Hearing impairments preventing use of audio headset (deafness, blindness)
- Claustrophobia
- First embryo transfer
- Fresh embryo transfer
- Persons under guardianship, curatorship or judicial protection
- Individuals deprived of liberty, persons receiving psychiatric care, and individuals admitted to a health or social facility for purposes other than clinical investigation
- Any medical condition judged by the investigator's expertise as incompatible with the research
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patients benefiting from the virtual reality hypnosis headset during frozen embryo transfer
The study will involve women, aged between 18 and 45, receiving care within the Reproductive Medicine Department at the Mother-Child-Woman Hospital in Lyon, as part of an assisted reproduction journey, and for whom a frozen embryo transfer is planned. The patients should have previously undergone an embryo transfer to be familiar with the medical procedure to be performed. Their partner must have planned to be present during the FET, in order to comply to identity vigilance regulations. The study will be proposed to them during the consultation scheduled for the dispensing of their prescriptions in preparation for the transfer. If the patient agrees to participate, she will then use a virtual reality hypnosis headset during her frozen embryo transfer. |
The virtual reality hypnosis headset will be used before, during, and after the FET procedure:
Prior to the procedure and the device setup, the patient will be asked to complete a self-assessment anxiety questionnaire, the State-Trait Anxiety Inventory. This self-assessment questionnaire is a validated and standardized tool designed to measure temporary "state" anxiety related to a specific situation (in this case, the embryo transfer). After the procedure, the patient will need to complete the questionnaire again, along with another set of questions specifically designed for our study. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The feasibility of using a virtual reality hypnosis headset for anxiolysis during a frozen embryo transfer
Time Frame: The composite criterion will be assessed through three binary questions (corresponding to the three constituent criteria) to be answered by the FET operator immediately after the procedure.
|
This is a combined criterion, requiring the validation of the following three criteria for the utilization of these headsets to be considered "feasible":
|
The composite criterion will be assessed through three binary questions (corresponding to the three constituent criteria) to be answered by the FET operator immediately after the procedure.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of medical device usage (number of minutes)
Time Frame: This information will be collected by the FET operator immediately after FET.
|
The duration will be estimated by the difference between the time of setting up the medical device and the time of removing the headset.
|
This information will be collected by the FET operator immediately after FET.
|
Measurement of procedure acceptability from the patients' perspective
Time Frame: This information will be completed by the patient immediately after the FET.
|
It will be determined by the presence or absence of adverse effects experienced during the use of the device, collected through a binary question to which the patient will respond. In case of a positive response, the adverse effects will then be described, based on a (non-exhaustive) list provided to the patient, along with a declarative item if the adverse effect is not present in the list. |
This information will be completed by the patient immediately after the FET.
|
Satisfaction rate of patient regarding the procedure.
Time Frame: This information will be completed by the patient immediately after the FET.
|
The assessment of satisfaction related to the use of the VRH headset will be measured using a Likert scale (very satisfied/satisfied/no opinion/dissatisfied/very dissatisfied).
|
This information will be completed by the patient immediately after the FET.
|
Satisfaction rate of healthcare providers regarding the procedure.
Time Frame: This information will be completed by the caregiver immediately after the FET.
|
The assessment of satisfaction related to the use of the VRH headset will be measured using a Likert scale (very satisfied/satisfied/no opinion/dissatisfied/very dissatisfied).
|
This information will be completed by the caregiver immediately after the FET.
|
Effect of VRH headset usage on patient anxiety, measured through the change in average anxiety score
Time Frame: The 〖"STAI-Y1" 〗_"STATE " self-assessment anxiety questionnaire will be provided to the patient in paper format just before the FET and immediately after the procedure.
|
Comparison of the average anxiety score measured using the 〖"STAI-Y1" 〗_"STATE " , before and after device usage.
|
The 〖"STAI-Y1" 〗_"STATE " self-assessment anxiety questionnaire will be provided to the patient in paper format just before the FET and immediately after the procedure.
|
Rate of biological pregnancies obtained after the FETs
Time Frame: This information will be obtained by reviewing the electronic medical records of the patients 1 month after the FET.
|
The proportion of patients who have achieved a biological pregnancy will be determined by collecting the systematically performed HCG level measurement 10 days after the transfer.
|
This information will be obtained by reviewing the electronic medical records of the patients 1 month after the FET.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL23_0510
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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