Skip to content

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

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05547724
Acronym
OREV
Enrollment
85
Registered
2022-09-21
Start date
2023-03-26
Completion date
2025-05-06
Last updated
2025-11-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

High Risk of Preterm Delivery

Keywords

virtual reality, anxiety, prematurity, pregnancy

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.

Interventions

OTHERVirtual reality

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

Sponsors

University Hospital, Limoges
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Impact of a virtual realityDay 1evaluation 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

Secondary

MeasureTime frameDescription
Number of deliveriesHours 12Number of deliveries in the 12 following hours VR.
Number of patients experiencing an increase in uterine contractionsHours 12Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.
Number of patients with rupture of membranesHours 12Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.
Evolution of Heart rate kineticsDay 2evolution of heart rate kinetics during VR in beats per minute within 48 hours
% of patients with Arterial hypotensionDay 2Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg
% of patients with difficulty falling asleepDay 2Proportion in % of patients with difficulty falling asleep the night after the visit, self-reported at the next day's medical visit.
Average length of visit in VRthrough study completion, a maximum of 18 weeksAverage length of visit for each patient
% of patients wtihCybercinetosisHours 2Individual mean score and number and proportion of patients with an SSQ score \> 38/48
% of patients wtih Visit interruptionHours 2proportion in % of patients who interrupted the visit
% of patients wtih Visit on tabletHours 2Proportion in % of patients who completed the visit on a tablet
% of patients wtih Renewal of the visit in VRthrough study completion, a maximum of 18 weeksProportion in % of patients wishing to repeat the visit
overall satisfactionthrough study completion, a maximum 18 weeksDescription of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)
Consumption of anxiolytics and analgesicsDay 2Variation in the use of anxiolytics and analgesics

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026