NCT05036772

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Poitiers University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Salpingography
• Virtual Reality Exposure Therapy
• Virtual Reality
• Pain
• Anxiety

Interventions

Type	Name	Description
DEVICE	Virtual reality	The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-03-08
• Completion: 2024-03-08
• First posted: 2021-09-08
• Last updated: 2024-12-03

Locations

1 site across 1 country: France