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

U

University of Limoges (UL)

Status

Terminated

Conditions

High Risk of Preterm Delivery

Treatments

Other: Virtual reality

Study type

Interventional

Funder types

Other

Identifiers

NCT05547724
87RI22_0027 (OREV)

Details and patient eligibility

About

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.

Full 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.

Enrollment

85 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)

Trial design

Primary purpose

Other

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

85 participants in 1 patient group

Virtual reality
Experimental group
Treatment:
Other: Virtual reality

Trial contacts and locations

1

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Central trial contact

Perrine COSTE-MAZEAU, MD

Data sourced from clinicaltrials.gov

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