Skip to main content
OpenTrials
Completed

NCT Number: NCT05036772

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Salpingography Anxiety Anxiety Disorders Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Virtual Reality Virtual Reality Exposure Therapy

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Poitiers, 86000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

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

Primary outcomes

  1. visual analog scale (EVA)

    Time frame: through study completion, an average of 1 year

    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?"

Secondary outcomes

  1. anxiety assessment

    Time frame: through study completion, an average of 1 year

    State Trait Inventory Anxiety (STAI Y-A) anxiety assessment questionnaire

  2. Dosimetry

    Time frame: through study completion, an average of 1 year

    Collection of the dose report produced surface in mGy.cm²

  3. Time of exam

    Time frame: through study completion, an average of 1 year

    Measurement of the time in minutes between the first shot and the last shot (the late evacuation shot will not be taken into account)

  4. - Cybersickness evaluation

    Time frame: through study completion, an average of 1 year

    simplified Virtual Reality Sickness Questionnaire (VRSQ) cybersickness scale. (Questionnaire in 9 items)

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

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

Acronym: Daphné

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Sep 8, 2021
Registry last updated
Dec 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.