Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Trial NCT06016582

Timeline & Enrollment

Primary Outcome

The feasibility of using a virtual reality hypnosis headset for anxiolysis during a frozen embryo transfer

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.

ICD-10 Classifications