Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery

NCT05547724 | Terminated

• 1 other identifier: 87RI22_0027 (OREV)
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

Patients at high risk of preterm birth are hospitalized with an high stress for their child's future. In order to better prepare the patient to a possible preterm delivery we use to propose her a visit of the neonatology unit. However, as a result of their obstetrical condition and of the pediatric staff disponibility, this visit is not always possible. Virtual Reality (VR) is well known to provide an immersive experience while staying in a unique place. Our project is to propose a virtual visit of the delivery room, neonatology unit and intensive care unit to all hospitalized patients at risk of preterm delivery in order to prepare and decompress them.

Conditions

High Risk of Preterm Delivery

Keywords

virtual reality; anxiety; prematurity; pregnancy

Outcome Measures

Primary Outcomes (1)

• Impact of a virtual reality

  evaluation of the impact of a virtual reality visit on the anxiety of hospitalized patients with a risk of preterm delivery with the STAI-YA questionary

  Day 1

Secondary Outcomes (13)

• Number of deliveries

  Hours 12

• Number of patients experiencing an increase in uterine contractions

  Hours 12

• Number of patients with rupture of membranes

  Hours 12

• Evolution of Heart rate kinetics

  Day 2

• % of patients with Arterial hypotension

  Day 2

Study Arms (1)

Virtual reality

EXPERIMENTAL

Other: Virtual reality

Interventions

Virtual reality OTHER

Virtual reality visit of the birth room, cesarean and pediatric hospitalization department: neonatology and neonatal intensive care

Virtual reality

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Hospitalized patient
• Patient with high risk of preterm delivery
• \> 24 Week of Gestation (WG) et ≤ 34 WG
• Patient who received corticosteroids for fetal lung maturation in the previous 24h
• Patient \> 18 years old

You may not qualify if:

• Patient no speak french
• no read french
• \> 34 WG
• Guardianship, curatorship, or under the protection of a conservator
• Foetus vital prognosis engaged
• Medical contraindication to virtual reality: Epilepsy, bipolarity, severe motion sickness ( evaluated by the patient herself : history of nausea, sweat, emesis during car, boat or airplane transportation … +/- preventive therapy)

Sponsors & Collaborators

• University Hospital, Limoges: lead

Study Sites (1)

Limoges Univesity Hospital

Limoges, 87042, France

Location

MeSH Terms

Conditions

Anxiety Disorders; Premature Birth

Condition Hierarchy (Ancestors)

Mental Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2022
• First Posted: September 21, 2022
• Study Start: March 26, 2023
• Primary Completion: May 6, 2025
• Study Completion: May 6, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)