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Clinical Trials/NCT05036772
NCT05036772
Completed
Not Applicable

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

Poitiers University Hospital1 site in 1 country60 target enrollmentMay 30, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Salpingography
Sponsor
Poitiers University Hospital
Enrollment
60
Locations
1
Primary Endpoint
visual analog scale (EVA)
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2022
End Date
March 8, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

  • - Cybersickness evaluation(through study completion, an average of 1 year)
  • Dosimetry(through study completion, an average of 1 year)
  • Time of exam(through study completion, an average of 1 year)
  • anxiety assessment(through study completion, an average of 1 year)

Study Sites (1)

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