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

Rennes University Hospital

Status: Completed

Conditions: IUD

Treatments: Other: VR+

Study type: Interventional

Funder types: Other

Identifiers

NCT04539899

35RC20_8886_REAVIST

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

VR+

Experimental group

Description:

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.

Treatment:

Other: VR+

VR-

No Intervention group

Description:

For patients in the control group, without a helmet, the course of the consultation will not be modified.