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Given the current lack of satisfactory options for the management of IUD insertion pain, could the virtual reality headset be an innovative and effective tool? The objective is to compare the pain experienced during IUD insertion between a group of women wearing a virtual reality helmet and a group not wearing one.
Observational, prospective, randomized, open-label, monocentric study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VR+ | Experimental | 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- | No Intervention | For patients in the control group, without a helmet, the course of the consultation will not be modified. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR+ | Other | Use of a virtual reality helmet during IUD insertion |
|
| Measure | Description | Time Frame |
|---|---|---|
| NRS during IUD insertion | The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful) | 20 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Stress level difference with virtual reality | Difference of stress between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = non stress and 10 = maximum of stress | 20 minutes |
| Satisfaction level difference with virtual reality |
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Inclusion Criteria:
Exclusion Criteria:
Method of female contraception
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Rennes | Rennes | 35000 | France | |||
| CHU Rennes |
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Randomized
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Difference of satisfaction between experimental and control group using self-assessment anxiety scale specially designed for the study, where 0 = not satisfied at all and 10 = totally satisfied |
| 20 minutes |
| Rennes |
| France |