Clinical trial NCT05547724: Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
Official title: Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Risk of Preterm Delivery
Keywords: virtual reality
anxiety
prematurity
pregnancy
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2022-09-21
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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)

Primary outcomes:
measure: Impact of a virtual reality
timeFrame: Day 1
Secondary outcomes:
measure: Number of deliveries
timeFrame: Hours 12
measure: Number of patients experiencing an increase in uterine contractions
timeFrame: Hours 12
measure: Number of patients with rupture of membranes
timeFrame: Hours 12
measure: Evolution of Heart rate kinetics
timeFrame: Day 2
measure: % of patients with Arterial hypotension
timeFrame: Day 2
measure: % of patients with difficulty falling asleep
timeFrame: Day 2
measure: Consumption of anxiolytics and analgesics
timeFrame: Day 2
measure: % of patients wtihCybercinetosis
timeFrame: Hours 2
measure: % of patients wtih Visit interruption
timeFrame: Hours 2
measure: % of patients wtih Visit on tablet
timeFrame: Hours 2
measure: Average length of visit in VR
timeFrame: through study completion, a maximum of 18 weeks
measure: % of patients wtih Renewal of the visit in VR
timeFrame: through study completion, a maximum of 18 weeks
measure: overall satisfaction
timeFrame: through study completion, a maximum 18 weeks
Other outcomes:
Locations:
city: Limoges
country: France
facility: Limoges Univesity Hospital
Study officials:
References: