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

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.

Study Overview

• Status: Terminated
• Conditions: High Risk of Preterm Delivery
• Intervention / Treatment: Other: Virtual reality

Detailed Description

Most of the future parents are unprepared to outcomes of their premature child and the neonatology unit visit has a demonstrated anxiolytic effect on them (decrease of 6.7 points on the State Trait Anxiety Inventory-form Y scale (STAI-Y1)) unfortunately, as a result of their obstetrical condition and of the pediatric staff disponibility, the visit of the neonatology unit is not always possible in time.

Furthermore VR is known to be an immersive experience wich had already proved its comforting interest during delivery or to prepare patient to a planned caesarean.

In this study we propose to all hospitalized and high risk of delivery early patients a virtual visit of the neonatology unit from their sit in the calm space of their room. If the patient doesn't tolerate or has some VR contraindication : a virtual visit is possible on digital tablet. The visit is presented after the foetal lung maturation by 48h of Betamethasone. Patients complete a STAI-Y-A survey before and after the experience and a Simulator Sickness Questionnaire (SSQ) questionary to evaluate their tolerance. All medical informations can be found in the medical record.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Limoges, France, 87042
    • Limoges Univesity Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality	Other: Virtual reality; Virtual reality visit of the birth room, cesarean and pediatric hospitalization department: neonatology and neonatal intensive care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of deliveries	Number of deliveries in the 12 following hours VR.	Hours 12
Number of patients experiencing an increase in uterine contractions	Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.	Hours 12
Number of patients with rupture of membranes	Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.	Hours 12
Evolution of Heart rate kinetics	evolution of heart rate kinetics during VR in beats per minute within 48 hours	Day 2
% of patients with Arterial hypotension	Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg	Day 2
% of patients with difficulty falling asleep	Proportion in % of patients with difficulty falling asleep the night after the visit, self-reported at the next day's medical visit.	Day 2
Consumption of anxiolytics and analgesics	Variation in the use of anxiolytics and analgesics	Day 2
% of patients wtihCybercinetosis	Individual mean score and number and proportion of patients with an SSQ score > 38/48	Hours 2
% of patients wtih Visit interruption	proportion in % of patients who interrupted the visit	Hours 2
% of patients wtih Visit on tablet	Proportion in % of patients who completed the visit on a tablet	Hours 2
Average length of visit in VR	Average length of visit for each patient	through study completion, a maximum of 18 weeks
% of patients wtih Renewal of the visit in VR	Proportion in % of patients wishing to repeat the visit	through study completion, a maximum of 18 weeks
overall satisfaction	Description of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)	through study completion, a maximum 18 weeks

Collaborators and Investigators

• Sponsor: University Hospital, Limoges

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2023
• Primary Completion (Actual): May 6, 2025
• Study Completion (Actual): May 6, 2025

Study Registration Dates

• First Submitted: September 10, 2022
• First Submitted That Met QC Criteria: September 19, 2022
• First Posted (Actual): September 21, 2022

Study Record Updates

• Last Update Posted (Actual): November 21, 2025
• Last Update Submitted That Met QC Criteria: November 18, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: anxiety; pregnancy; prematurity; virtual reality
• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth; Anxiety Disorders
• Other Study ID Numbers: 87RI22_0027 (OREV)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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