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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04539899

Acronym

REAVIST

Enrollment

100

Registered

2020-09-07

Start date

2020-09-23

Completion date

2022-04-29

Last updated

2022-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IUD

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.

Interventions

OTHERVR+

Use of a virtual reality helmet during IUD insertion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Intervention model description

Randomized

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026