Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery (OREV)
Primary Purpose
High Risk of Preterm Delivery
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Virtual reality
Sponsored by
About this trial
This is an interventional other trial for High Risk of Preterm Delivery focused on measuring virtual reality, anxiety, prematurity, pregnancy
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)
Sites / Locations
- Limoges Univesity HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Virtual reality
Arm Description
Outcomes
Primary Outcome Measures
Impact of a virtual reality
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
Number of deliveries
Number of deliveries in the 12 following hours VR.
Number of patients experiencing an increase in uterine contractions
Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.
Number of patients with rupture of membranes
Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.
Evolution of Heart rate kinetics
evolution of heart rate kinetics during VR in beats per minute within 48 hours
% of patients with Arterial hypotension
Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg
% of patients with difficulty falling asleep
Proportion in % of patients with difficulty falling asleep the night after the visit, self-reported at the next day's medical visit.
Consumption of anxiolytics and analgesics
Variation in the use of anxiolytics and analgesics
% of patients wtihCybercinetosis
Individual mean score and number and proportion of patients with an SSQ score > 38/48
% of patients wtih Visit interruption
proportion in % of patients who interrupted the visit
% of patients wtih Visit on tablet
Proportion in % of patients who completed the visit on a tablet
Average length of visit in VR
Average length of visit for each patient
% of patients wtih Renewal of the visit in VR
Proportion in % of patients wishing to repeat the visit
overall satisfaction
Description of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)
Full Information
NCT ID
NCT05547724
First Posted
September 10, 2022
Last Updated
May 24, 2023
Sponsor
University Hospital, Limoges
1. Study Identification
Unique Protocol Identification Number
NCT05547724
Brief Title
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
Acronym
OREV
Official Title
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 26, 2023 (Actual)
Primary Completion Date
February 12, 2025 (Anticipated)
Study Completion Date
February 12, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Limoges
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High Risk of Preterm Delivery
Keywords
virtual reality, anxiety, prematurity, pregnancy
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual reality
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Virtual reality
Intervention Description
Virtual reality visit of the birth room, cesarean and pediatric hospitalization department: neonatology and neonatal intensive care
Primary Outcome Measure Information:
Title
Impact of a virtual reality
Description
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
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Number of deliveries
Description
Number of deliveries in the 12 following hours VR.
Time Frame
Hours 12
Title
Number of patients experiencing an increase in uterine contractions
Description
Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.
Time Frame
Hours 12
Title
Number of patients with rupture of membranes
Description
Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.
Time Frame
Hours 12
Title
Evolution of Heart rate kinetics
Description
evolution of heart rate kinetics during VR in beats per minute within 48 hours
Time Frame
Day 2
Title
% of patients with Arterial hypotension
Description
Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg
Time Frame
Day 2
Title
% of patients with difficulty falling asleep
Description
Proportion in % of patients with difficulty falling asleep the night after the visit, self-reported at the next day's medical visit.
Time Frame
Day 2
Title
Consumption of anxiolytics and analgesics
Description
Variation in the use of anxiolytics and analgesics
Time Frame
Day 2
Title
% of patients wtihCybercinetosis
Description
Individual mean score and number and proportion of patients with an SSQ score > 38/48
Time Frame
Hours 2
Title
% of patients wtih Visit interruption
Description
proportion in % of patients who interrupted the visit
Time Frame
Hours 2
Title
% of patients wtih Visit on tablet
Description
Proportion in % of patients who completed the visit on a tablet
Time Frame
Hours 2
Title
Average length of visit in VR
Description
Average length of visit for each patient
Time Frame
through study completion, a maximum of 18 weeks
Title
% of patients wtih Renewal of the visit in VR
Description
Proportion in % of patients wishing to repeat the visit
Time Frame
through study completion, a maximum of 18 weeks
Title
overall satisfaction
Description
Description of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)
Time Frame
through study completion, a maximum 18 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Perrine COSTE-MAZEAU, MD
Phone
555056607
Ext
+33
Email
perrine.costemazeau@chu-limoges.fr
Facility Information:
Facility Name
Limoges Univesity Hospital
City
Limoges
ZIP/Postal Code
87042
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Perrine COSTE-MAZEAU, MD
Phone
555056607
Ext
+33
Email
perrine.costemazeau@chu-limoges.fr
First Name & Middle Initial & Last Name & Degree
Perrine COSTE-MAZEAU, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
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