Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)

Study Overview
=================
Brief Summary
-----------------
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

Detailed Description
-----------------
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.

Official Title
-----------------
Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.

Conditions
-----------------
Salpingography, Virtual Reality Exposure Therapy, Virtual Reality, Pain, Anxiety

Intervention / Treatment
-----------------
* Device: Virtual reality


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients over 18 years old patients with a prescription for hysterosalpingography patients able to answer the questionnaire independently (French-speaking or understanding French) informed consent, signed by the patient patients benefiting from a social security scheme or benefiting through a third party Exclusion Criteria: patients with a contraindication to virtual reality headset. refusal to participate in the study Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection) patient under guardianship, curatorship or subordination

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Practice<br>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 | |
| Experimental: Interventionnal<br>The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography. | Device: Virtual reality<br>* The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |