Evaluation of the Influence of the Virtual Reality Helmet on Pain During IUD Insertion
- Conditions
- IUD
- Registration Number
- NCT04539899
- Lead Sponsor
- Rennes University Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method NRS during IUD insertion 20 minutes The assessment criterion used is the written self-report numerical scale (NRS) from 0 to 10 (0 = no pain, 10 = extremely painful)
- Secondary Outcome Measures
Name Time Method Satisfaction level difference with virtual reality 20 minutes 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
Stress level difference with virtual reality 20 minutes 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
Related Research Topics
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Trial Locations
- Locations (1)
CHU Rennes
🇫🇷Rennes, France
CHU Rennes🇫🇷Rennes, France