Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion : REAVIST

Conditions
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IUD

Intervention / Treatment
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* Other: VR+


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Female adult 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: Pre-existing dizzying sensations Severe facial wounds History of epilepsy Persons of full age subject to legal protection (safeguard of justice, curatorship, guardianship), persons deprived of liberty.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VR+<br>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. | Other: VR+<br>* Use of a virtual reality helmet during IUD insertion<br>|
| No Intervention: VR-<br>For patients in the control group, without a helmet, the course of the consultation will not be modified. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |