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

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

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.

Study Overview

• Status: Completed
• Conditions: IUD
• Intervention / Treatment: Other: VR+

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • CHU Rennes
  • Rennes, France
    • CHU Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: VR+; 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.	Other: VR+; Use of a virtual reality helmet during IUD insertion
NO_INTERVENTION: VR-; For patients in the control group, without a helmet, the course of the consultation will not be modified.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Rennes University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 23, 2020
• Primary Completion (ACTUAL): April 29, 2022
• Study Completion (ACTUAL): April 29, 2022

Study Registration Dates

• First Submitted: August 31, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (ACTUAL): September 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2022
• Last Update Submitted That Met QC Criteria: May 2, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 35RC20_8886_REAVIST

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No