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NCT04539899 Clinical Trial

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

IUD Clinical Trial

— REAVIST  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04539899
Other study ID # 35RC20_8886_REAVIST
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 23, 2020
Est. completion date April 29, 2022

Study information
Verified date April 2022
Source Rennes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date April 29, 2022
Est. primary completion date April 29, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• VR+
Use of a virtual reality helmet during IUD insertion

Locations
Country Name City State
France CHU Rennes Rennes
France CHU Rennes Rennes

Sponsors (1)
Lead Sponsor Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
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