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

Sponsor

Rennes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04539899

Collaborator

(none)

100

Enrollment

Locations

Arms

19.2

Actual Duration (Months)

Patients Per Site

2.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
IUD	Other: VR+	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

RandomizedRandomized

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Sep 23, 2020

Actual Primary Completion Date :

Apr 29, 2022

Actual Study Completion Date :

Apr 29, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Rennes	Rennes		France	35000
2	CHU Rennes	Rennes		France

Sponsors and Collaborators

Rennes University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rennes University Hospital

ClinicalTrials.gov Identifier:

NCT04539899

Other Study ID Numbers:

35RC20_8886_REAVIST

First Posted:

Sep 7, 2020

Last Update Posted:

May 4, 2022

Last Verified:

Apr 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 4, 2022