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

Not Applicable

Completed

• Conditions: IUD
• Interventions: Other: VR+

• Registration Number: NCT04539899
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-31
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-07
• Study Start: 2020-09-23
• Status Verified: 2022-04
• Primary Completion: 2022-04-29
• Study Completion: 2022-04-29
• Last Update Submitted: 2022-05-02
• Last Update Posted: 2022-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
VR+	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

CHU Rennes; 🇫🇷 Rennes, France