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

Pain Clinical Trial

— Daphné  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05036772
• Other study ID #: Daphné
• Status: Completed
• Phase: N/A
• Start date: May 30, 2022
• Est. completion date: March 8, 2024

Study information

• Verified date: March 2024
• Source: Poitiers University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 8, 2024
• Est. primary completion date: March 8, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Pain
• Virtual Reality
• Virtual Reality Exposure Therapy

Intervention

Device:
• Virtual reality
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	anxiety assessment	State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire	through study completion, an average of 1 year
Secondary	Dosimetry	Collection of the dose report produced surface in mGy.cm²	through study completion, an average of 1 year
Secondary	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
Secondary	- Cybersickness evaluation	simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)	through study completion, an average of 1 year