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

Anxiety Clinical Trial

— Hypno-TEC  

Official title:

Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Hypno-TEC Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06016582
• Other study ID #: 69HCL23_0510
• Status: Completed
• Phase: N/A
• Start date: December 13, 2023
• Est. completion date: May 24, 2024

Study information

• Verified date: June 2024
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 24, 2024
• Est. primary completion date: May 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety

Intervention

Device:
• 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.

Locations

Country	Name	City	State
France	Hôpital Femme Mère Enfant	Bron	Rhône

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The feasibility of using a virtual reality hypnosis headset for anxiolysis during a frozen embryo transfer	This is a combined criterion, requiring the validation of the following three criteria for the utilization of these headsets to be considered "feasible": Availability of the headset on the day of the FET (yes/no); Provision of the headset by the caregiver of the FET (yes/no); Optimal use of the headset during the FET (yes/no) (i.e., optimal use is defined as the absence of technical incidents or battery depletion throughout the headset's usage duration during the procedure) A negative response to any of these three criteria will result in the procedure being deemed not 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	Duration of medical device usage (number of minutes)	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.
Secondary	Measurement of procedure acceptability from the patients' perspective	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.
Secondary	Satisfaction rate of patient regarding the procedure.	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.
Secondary	Satisfaction rate of healthcare providers regarding the procedure.	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.
Secondary	Effect of VRH headset usage on patient anxiety, measured through the change in average anxiety score	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.
Secondary	Rate of biological pregnancies obtained after the FETs	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.