Clinical trial NCT05925400: Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET)
Official title: Effect of Virtual Reality On IN-Vitro fEcuNdation ouTcomes: a Randomized Controlled Trial (VR-INVENT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IVF
Stress
Anxiety
Keywords: Virtual Reality
Embryo transfer
Pregnancy rate
Lead sponsor: CMC Ambroise Paré
Sponsor class: OTHER
First posted: 2023-06-29
Enrollment: 760
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study compares the use of virtual Reality versus the usual service protocol for the management of anxiety and pain related to In-Vitro fertilization (IVF) procedure

Detailed description: Medical interventions often cause pain, distress or anxiety for most patients.

The use of music and movies has proven effective in pediatrics.

Virtual Reality (VR) is a newer technology that immerses users in a pleasant, three-dimensional environment via a headset. By distracting patients, this technology can reduce anxiety, discomfort and ultimately pain associated with care.

This randomized monocentric trial compares the effect of the use of VR versus without VR during the transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development.

The primary outcome will include clinical pregnancy rate and the secondary outcome focuses on the patient's levels of anxiety and stress.

Data on the level of anxiety and stress will be collected through questionnaires before and after the procedure. Also, clinical pregnancy, defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity, will be assessed through ultrasons 8 ± 4 weeks after the procedure

Eligibility criteria: Inclusion Criteria:

* Will benefit from in vitro Fertilization (IVF or ICSI)
* Aged over 18 and under 43,
* Attempt Rank 1 or 2
* Requiring a transfer of a single fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development
* Having received information and given their consent to participate in accordance with the regulations
* Benefiting from a social security scheme or entitled.

Exclusion Criteria:

* Use of frozen sperm
* Use of testicular sperm
* Fecundation technique used: IMSI
* Early embryo transfer on D2 or D3
* Inability to understand the information given
* Under guardianship, under curatorship or under safeguard of justice,
* Communication difficulties or neuropsychic disorders,
* Current corneal or conjunctival pathologies,
* Claustrophobia,
* Appearance of nausea in the mountains or at sea,
* Regular use of anxiolytics

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: Assessed 12 weeks after embryo transfer
Secondary outcomes:
measure: State and Trait Anxiety Inventory (STAI) questionnaires
timeFrame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
measure: Generalized Anxiety Disorder - 7 (GAD-7) questionnaires
timeFrame: Questionnaires will be filled out in 2 different time points during the study: 1) ET day, 45 minutes before ET 2) ET day, 10 minutes after ET procedure
Other outcomes:
Locations:
city: Neuilly-sur-Seine
country: France
facility: Clinique Pierre Cherest
Study officials:
References: