Assessment of Patients' Pain and Anxiety During a Hysterosalpingography Narratified by a Virtual Reality Helmet (Daphné)
NCT ID: NCT05036772
Last Updated: 2024-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2022-05-30
2024-03-08
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Standard Practice
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
No interventions assigned to this group
Interventionnal
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Virtual reality
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Interventions
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Virtual reality
The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
Eligibility Criteria
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Inclusion Criteria
* 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
* refusal to participate in the study
* Contraindication to the realization of hysterosalpingography (pregnancy / lactation or infection)
* patient under guardianship, curatorship or subordination
18 Years
FEMALE
No
Sponsors
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Poitiers University Hospital
OTHER
Responsible Party
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Locations
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Centre Hospitalier Universitaire
Poitiers, , France
Countries
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Other Identifiers
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Daphné
Identifier Type: -
Identifier Source: org_study_id