NCT04539899

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 7, 2020

Completed
16 days until next milestone

Study Start

First participant enrolled

September 23, 2020

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2022

Completed
Last Updated

May 4, 2022

Status Verified

April 1, 2022

Enrollment Period

1.6 years

First QC Date

August 31, 2020

Last Update Submit

May 2, 2022

Conditions

IUD

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Stress level difference with virtual reality

    20 minutes

  • Satisfaction level difference with virtual reality

    20 minutes

Study Arms (2)

VR+

EXPERIMENTAL

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+

VR-

NO INTERVENTION

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

Interventions

VR+OTHER

Use of a virtual reality helmet during IUD insertion

VR+

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsMethod of female contraception
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

CHU Rennes

Rennes, 35000, France

Location

CHU Rennes

Rennes, France

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2020

First Posted

September 7, 2020

Study Start

September 23, 2020

Primary Completion

April 29, 2022

Study Completion

April 29, 2022

Last Updated

May 4, 2022

Record last verified: 2022-04

Locations

FR(2)