Clinical trial NCT05036772: Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)
Official title: Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Salpingography
Virtual Reality Exposure Therapy
Virtual Reality
Pain
Anxiety
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: visual analog scale (EVA)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: anxiety assessment
timeFrame: through study completion, an average of 1 year
measure: Dosimetry
timeFrame: through study completion, an average of 1 year
measure: Time of exam
timeFrame: through study completion, an average of 1 year
measure: - Cybersickness evaluation
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References: