Clinical trial NCT06016582: Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer
Official title: Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Hypno-TEC Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Keywords: Virtual Reality Hypnosis
Medical Device
Anxiety
Frozen embryo transfer
Feasibility
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: The feasibility of using a virtual reality hypnosis headset for anxiolysis during a frozen embryo transfer
timeFrame: 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 outcomes:
measure: Duration of medical device usage (number of minutes)
timeFrame: This information will be collected by the FET operator immediately after FET.
measure: Measurement of procedure acceptability from the patients' perspective
timeFrame: This information will be completed by the patient immediately after the FET.
measure: Satisfaction rate of patient regarding the procedure.
timeFrame: This information will be completed by the patient immediately after the FET.
measure: Satisfaction rate of healthcare providers regarding the procedure.
timeFrame: This information will be completed by the caregiver immediately after the FET.
measure: Effect of VRH headset usage on patient anxiety, measured through the change in average anxiety score
timeFrame: 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.
measure: Rate of biological pregnancies obtained after the FETs
timeFrame: This information will be obtained by reviewing the electronic medical records of the patients 1 month after the FET.
Other outcomes:
Locations:
city: Bron
country: France
facility: Hôpital Femme Mère Enfant
state: Rhône
Study officials:
References: