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
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• IUD

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