Interest of Virtual Reality in the Management of Anxiety and Pain During Embryo Transfer (ET) (VR-INVENT)

CMC Ambroise Paré

Status: Terminated

Conditions: IVF; Anxiety; Stress

Treatments: Device: Virtual Reality during Embryo Transfer

Study type: Interventional

Funder types: Other

Identifiers

NCT05925400

2022/02

Details and patient eligibility

About

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

Full 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

Enrollment: 12 patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

ET without RV

No Intervention group

Description:

Patients who will be randomized to the control group will wait for transfer of a fresh blastocyst on the 5th day of development OR a frozen embryo on the 5th day of development according to the usual service protocol.

ET with RV

Experimental group

Description:

The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure

Treatment:

Device: Virtual Reality during Embryo Transfer