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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ET without RV | No Intervention | 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 | The transfer and preparation in the transfer room will be done according to the usual service protocol. Exposure to virtual reality environment exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality during Embryo Transfer | Device | Patients randomized to the study group, will be provided with the VR headset. The VR exposure will take place 10-15 minutes before the Embryo Transfer (ET) and a 10 min immersion after the ET |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Clinical Pregnancy Rate defined by the presence of one or more gestational sacs with one or more embryos showing cardiac activity | Assessed 12 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| State and Trait Anxiety Inventory (STAI) questionnaires | The rate of anxiety and stress level before and after embryo transfer, measured by the State and Trait Anxiety Inventory (STAI) StAI-Y1-State ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety) StAI-Y2-Trait ranging from 20 to 80 (20 = Low Level of Anxiety), 80 = High Level Of Anxiety) | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Pierre Cherest | Neuilly-sur-Seine | 92200 | France |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| Generalized Anxiety Disorder - 7 (GAD-7) questionnaires | The rate of anxiety and stress level before and after embryo transfer, measured by Generalized Anxiety Disorder - 7 (GAD-7) questionnaires GAD-7 ranging from 0 to 21 (0= No or Minimal Stress, 21= Worst Possible Stress) | 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 |