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

Sponsor
University Hospital, Limoges (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05547724
Collaborator
(none)
120
1
1
22.6
5.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Virtual reality
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
Anticipated Study Start Date :
Oct 15, 2022
Anticipated Primary Completion Date :
Sep 1, 2024
Anticipated Study Completion Date :
Sep 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Impact of a virtual reality [Day 1]

    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

Secondary Outcome Measures

  1. Number of deliveries [Hours 12]

    Number of deliveries in the 12 following hours VR.

  2. Number of patients experiencing an increase in uterine contractions [Hours 12]

    Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.

  3. Number of patients with rupture of membranes [Hours 12]

    Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.

  4. Evolution of Heart rate kinetics [Day 2]

    evolution of heart rate kinetics during VR in beats per minute within 48 hours

  5. % of patients with Arterial hypotension [Day 2]

    Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg

  6. % of patients with difficulty falling asleep [Day 2]

    Proportion in % of patients with difficulty falling asleep the night after the visit, self-reported at the next day's medical visit.

  7. Consumption of anxiolytics and analgesics [Day 2]

    Variation in the use of anxiolytics and analgesics

  8. % of patients wtihCybercinetosis [Hours 2]

    Individual mean score and number and proportion of patients with an SSQ score > 38/48

  9. % of patients wtih Visit interruption [Hours 2]

    proportion in % of patients who interrupted the visit

  10. % of patients wtih Visit on tablet [Hours 2]

    Proportion in % of patients who completed the visit on a tablet

  11. Average length of visit in VR [through study completion, a maximum of 18 weeks]

    Average length of visit for each patient

  12. % of patients wtih Renewal of the visit in VR [through study completion, a maximum of 18 weeks]

    Proportion in % of patients wishing to repeat the visit

  13. overall satisfaction [through study completion, a maximum 18 weeks]

    Description of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts 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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Limoges Univesity Hospital Limoges France 87042

Sponsors and Collaborators

  • University Hospital, Limoges

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT05547724
Other Study ID Numbers:
  • 87RI22_0027 (OREV)
First Posted:
Sep 21, 2022
Last Update Posted:
Sep 21, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University Hospital, Limoges
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2022