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

Poitiers University Hospital

Status: Completed

Conditions: Salpingography; Virtual Reality Exposure Therapy; Anxiety; Pain; Virtual Reality

Treatments: Device: Virtual reality

Study type: Interventional

Funder types: Other

Identifiers

NCT05036772

Daphné

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 2 patient groups

Standard Practice

No Intervention group

Description:

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 group

Description:

The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.

Treatment:

Device: Virtual reality