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

NCT ID: NCT05547724

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 85 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-26
• Study Completion Date: 2025-05-06

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.

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.

Conditions

High Risk of Preterm Delivery

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Virtual reality

Group Type: EXPERIMENTAL

Virtual reality

Intervention Type: OTHER

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

Interventions

Virtual reality

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

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Limoges

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Limoges Univesity Hospital

Limoges, , France

Countries

France

Other Identifiers

87RI22_0027 (OREV)

Identifier Type: -

Identifier Source: org_study_id