High Risk of Preterm DeliveryOREVNCT05547724
Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
A study testing Virtual reality in people with High Risk of Preterm Delivery, run by University Hospital, Limoges at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk of Preterm Delivery
- What is being tested?
- Virtual reality
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2023to 6 May 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- High Risk of Preterm Delivery
- Being tested
- Virtual reality
- Keywords
- virtual reality, anxiety, prematurity, pregnancy
- Medical subject headings
- Anxiety Disorders, Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityOther
Virtual reality visit of the birth room, cesarean and pediatric hospitalization department: neonatology and neonatal intensive care
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | Not described Receives: Other: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Day 1
Secondary outcomes (13)
Number of deliveries
Number of deliveries in the 12 following hours VR.
Measured: Hours 12
Number of patients experiencing an increase in uterine contractions
Number of patients experiencing an increase in uterine contractions in the 12 following hours VR.
Measured: Hours 12
Number of patients with rupture of membranes
Number of patients with rupture of membranes obstetrical complications in the 12 following hours VR.
Measured: Hours 12
Evolution of Heart rate kinetics
evolution of heart rate kinetics during VR in beats per minute within 48 hours
Measured: Day 2
% of patients with Arterial hypotension
Proportion in % of patients with arterial hypotension within 2 hours after VR in mmHg
Measured: Day 2
% 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.
Measured: Day 2
Consumption of anxiolytics and analgesics
Variation in the use of anxiolytics and analgesics
Measured: Day 2
% of patients wtihCybercinetosis
Individual mean score and number and proportion of patients with an SSQ score > 38/48
Measured: Hours 2
% of patients wtih Visit interruption
proportion in % of patients who interrupted the visit
Measured: Hours 2
% of patients wtih Visit on tablet
Proportion in % of patients who completed the visit on a tablet
Measured: Hours 2
Average length of visit in VR
Average length of visit for each patient
Measured: through study completion, a maximum of 18 weeks
% of patients wtih Renewal of the visit in VR
Proportion in % of patients wishing to repeat the visit
Measured: through study completion, a maximum of 18 weeks
overall satisfaction
Description of the patient's overall satisfaction of this study with Lickert's scale (Score between 0 unnecessary and 10 very useful)
Measured: through study completion, a maximum 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start26 Mar 2023
- Primary completion6 May 2025
- Study completion6 May 2025
Why it stopped: departure of the principal investigator without replacement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk of Preterm DeliveryStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05547724
- Sponsor's protocol ID
- 87RI22_0027 (OREV)
- Acronym
- OREV
- Status last verified
- Nov 2025
- First submitted
- 10 Sep 2022
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Virtual Reality for the Management of Hospitalized Pregnant Patients at Risk of Preterm Delivery
- ClinicalTrials.gov ID
- NCT05547724
- Acronym / sponsor ID
- OREV / 87RI22_0027 (OREV)
- Conditions
- High Risk of Preterm Delivery
- Keywords
- virtual reality, anxiety, prematurity, pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: departure of the principal investigator without replacement
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 26 Mar 2023 (actual)
- Primary completion
- 6 May 2025 (actual)
- Study completion
- 6 May 2025 (actual)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Other: Virtual reality |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Patient no speak french
- no read french
- > 34 WG
- Guardianship, curatorship, or under the protection of a conservator
- Foetus vital prognosis engaged
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityVirtual reality visit of the birth room, cesarean and pediatric hospitalization department: neonatology and neonatal intensive care | Other | Virtual reality |
Primary outcome
Impact of a virtual reality
Time frame: 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
13 secondary outcomes
Number of deliveries
Time frame: Hours 12
Number of patients experiencing an increase in uterine contractions
Time frame: Hours 12
Number of patients with rupture of membranes
Time frame: Hours 12
Evolution of Heart rate kinetics
Time frame: Day 2
% of patients with Arterial hypotension
Time frame: Day 2
% of patients with difficulty falling asleep
Time frame: Day 2
Consumption of anxiolytics and analgesics
Time frame: Day 2
% of patients wtihCybercinetosis
Time frame: Hours 2
% of patients wtih Visit interruption
Time frame: Hours 2
% of patients wtih Visit on tablet
Time frame: Hours 2
Average length of visit in VR
Time frame: through study completion, a maximum of 18 weeks
% of patients wtih Renewal of the visit in VR
Time frame: through study completion, a maximum of 18 weeks
overall satisfaction
Time frame: through study completion, a maximum 18 weeks
Results and safety
The study was stopped early (reason given: departure of the principal investigator without replacement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with High Risk of Preterm Delivery, run by University Hospital, Limoges at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: departure of the principal investigator without replacement). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of a virtual reality (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.