Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion
NCT ID: NCT04539899
Last Updated: 2022-05-04
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
100 participants
INTERVENTIONAL
2020-09-23
2022-04-29
Brief Summary
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Observational, prospective, randomized, open-label, monocentric study.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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VR+
For patients in the experimental group, using the virtual reality helmet, the caregiver will position the helmet on the patient when she is placed on the gynecological examination table. He or she will make sure that the patient can see and hear the current sequence. The caregiver can then proceed with the different steps of the IUD insertion. Once the procedure is completed, the caregiver will indicate to the patient that she can remove the headphones.
VR+
Use of a virtual reality helmet during IUD insertion
VR-
For patients in the control group, without a helmet, the course of the consultation will not be modified.
No interventions assigned to this group
Interventions
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VR+
Use of a virtual reality helmet during IUD insertion
Eligibility Criteria
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Inclusion Criteria
* Who has benefited from contraceptive counseling
* The choice of an IUD (hormonal or copper)
* Having signed a written informed consent.
* Affiliation to a social security scheme.
Exclusion Criteria
* Severe facial wounds
* History of epilepsy
* Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.
18 Years
FEMALE
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Locations
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CHU Rennes
Rennes, , France
CHU Rennes
Rennes, , France
Countries
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Other Identifiers
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35RC20_8886_REAVIST
Identifier Type: -
Identifier Source: org_study_id
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