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Compare the maximum pain and anxiety experienced between the group using a virtual reality headset and the control group in an adult woman during a hysterosalpingography examination
In France, 1 couples out of 5 consults for suspected infertility. Hysterosalpingography is the first line diagnostic examination in this course and can sometimes be therapeutic. This gynecological examination is invasive in nature, this exam requires an administration of iodinated contrast product by the endocavitary route.
Hysterosalpingography is the most painful examination in this treatment path and pain's assessment is classified as strong by the French National Authority for Health (Haute Autérité de Santé) and anxiety-inducing. For these patients, drug analgesic treatments remain ineffective or contraindicated in outpatient mode. Ionizing irradiation is a constraint that makes hypnosis unsuitable.
Several studies show the contribution of a virtual reality headset in reducing pain and anxiety by inducing patients in an hypnotic environment. This tool standardizes interventions based on changes in consciousness. It is an easy-to-use, non-drug analgesia with few side effects and inexpensive.
The environment offered by this medical device is based on evidence to peacefully escort patients on a journey of natural elements. Calm music is made up of key elements of musical therapy. A medical anesthesiologist and hypnotherapist wrote the hypnotic induction. And, the voice is the one of an experienced sociologist in practice. A simple meditation modeled on heart synchronization sets a persistent goal during this immersion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Practice | No Intervention | The control arm is supported according to the usual practice. The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography | |
| Interventionnal | Experimental | The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual reality | Device | The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| visual analog scale (EVA) | The patient rates her pain level between 0 and 10. The standard question is: "From 0 to 10, with 0 absence of pain and 10 maximum pain, how much will you rate the maximum pain experienced during your examination?" | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| anxiety assessment | State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire | through study completion, an average of 1 year |
| Dosimetry | Collection of the dose report produced surface in mGy.cm² |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Universitaire | Poitiers | 86000 | France |
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| through study completion, an average of 1 year |
| Time of exam | Measurement of the time in minutes between the first shot and the last shot (the late evacuation shot will not be taken into account) | through study completion, an average of 1 year |
| - Cybersickness evaluation | simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items) | through study completion, an average of 1 year |
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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