Ignite Creation Date:
2024-05-06 @ 7:27 PM
Last Modification Date:
2024-10-26 @ 3:07 PM
Study NCT ID:
NCT06016582
Status:
COMPLETED
Last Update Posted:
2024-06-10
First Post:
2023-08-21
Brief Title:
Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer
Sponsor:
Hospices Civils de Lyon
Organization:
Hospices Civils de Lyon
Study Overview
Official Title:
Use of Virtual Reality Medical Hypnosis for Anxiolytic Purposes During Frozen Embryo Transfer - Hypno-TEC Feasibility Study
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hypno-TEC
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 42 of medical device regulations according to European Regulation 2017745
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 procedures 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
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 42 of medical device regulations according to European Regulation 2017745
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 procedures 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None