Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer

NCT ID: NCT06016582

Last Updated: 2024-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-13
• Study Completion Date: 2024-05-24

Brief Summary

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.

Conditions

Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Use of virtual reality hypnosis headset during frozen embryo transfer

Intervention Type: DEVICE

The virtual reality hypnosis headset will be used before, during, and after the FET procedure:

• The headset will be put on 5 minutes prior to the procedure, allowing time for immersion in the virtual world.
• The headset will be kept on throughout the entire procedure (procedure duration less than 5 minutes).
• The headset will be worn for up to 5 minutes after the procedure. The patient will be free to choose her own auditory and visual scenario for the session.

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.

Interventions

Use of virtual reality hypnosis headset during frozen embryo transfer

The virtual reality hypnosis headset will be used before, during, and after the FET procedure:

• The headset will be put on 5 minutes prior to the procedure, allowing time for immersion in the virtual world.
• The headset will be kept on throughout the entire procedure (procedure duration less than 5 minutes).
• The headset will be worn for up to 5 minutes after the procedure. The patient will be free to choose her own auditory and visual scenario for the session.

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Femme Mère Enfant

Bron, Rhône, France

Countries

France

Other Identifiers

69HCL23_0510

Identifier Type: -

Identifier Source: org_study_id