AnxietyNCT03064061
Impact of Virtual Reality Before Oocytes Retrieval on Anxiety and Pregnancy Rate
A study testing Virtual reality in people with Anxiety and in Vitro Fertilization, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety, in Vitro Fertilization, Virtual Reality
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 600 participants
- Where
- 1 siteBelgium
- Study dates
- 17 Feb 2017to 30 Jun 2019
- 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 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
- Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)
Who cannot join
- Patients with long-term psychotherapeutic treatment
- Patients taking psychotropic drugs
- patient blind and deaf
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Cliniques universitaires Saint-luc
Brussels, 1200
Fabienne Roelants, MD, +3227641821, fabienne.roelants@uclouvain.be
Célilne Pirard, MD PhD, +3227644112, celine.pirard@uclouvain.be
About this study
Official title: Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate
The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.
- Conditions
- Anxiety, in Vitro Fertilization, Virtual Reality
- Being tested
- Virtual reality
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
a device with virtual reality is given to the patients with a film of 18 minutes
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Neutral | Sham comparator | neutral VR session before oocytes retrieval Receives: Device: Virtual reality |
| Virtual reality Anxiety | Active comparator | VR session with the goal of reducing anxiety before oocytes retrieval Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
impact of the virtual reality on the pregnancy rate (Ultrasound)
measured by ultrasound
Measured: 12 weeks
Secondary outcomes (4)
impact of the virtual reality on anxiety (numeric scale)
measured with numeric scale (0-10) before and after the VR
Measured: immediate
impact of the virtual reality on satisfaction
measured by a numeric scale 0-10
Measured: immediate
impact of the virtual reality on pregnancy test
measured by blood beta HCG level
Measured: 6 weeks
state-trait Anxiety Inventory
measured with STAI Y-A Spielberger before and after the VR and when leaving the hospital
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start17 Feb 2017
- Primary completionMar 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roelants, Cliniques universitaires Saint-Luc- Université Catholique de Louvain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064061
- Sponsor's protocol ID
- 2016/20JUL/346
- Status last verified
- Mar 2018
- First submitted
- 26 Dec 2016
- Last updated
- 22 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Virtual Reality Experience, Before Oocytes Retrieval for In-vitro Fertilisation Treatment, on Anxiety and on the Pregnancy Rate
- ClinicalTrials.gov ID
- NCT03064061
- Acronym / sponsor ID
- 2016/20JUL/346
- Conditions
- Anxiety, in Vitro Fertilization, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 17 Feb 2017 (actual)
- Primary completion
- Mar 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 24 Feb 2017 (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.
The primary objective of this study is to evaluate the impact of a session of virtual reality (VR) with the objective of lowering the anxiety level on the clinical pregnancy rate following an In-vitro fertilisation (IVF) procedure. Indeed, anxiety in relation to infertility happens frequently and over time, can become stressful for our patients. This level of stress influences the effect of the infertility treatment. Reducing anxiety levels could promote the ability of the patients to face this stress and promote a greater chance of pregnancy in that context.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Neutral | Sham comparator | Device: Virtual realityneutral VR session before oocytes retrieval |
| Virtual reality Anxiety | Active comparator | Device: Virtual realityVR session with the goal of reducing anxiety before oocytes retrieval |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Adult patients benefiting from an oocytes retrieval as part of their IVF at Cliniques universitaires Saint-Luc.
- Simple IVF / IVF Intracytoplasmic sperm injection (ICSI)
Key exclusion criteria (3 listed)
- Patients with long-term psychotherapeutic treatment
- Patients taking psychotropic drugs
- patient blind and deaf
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 realitya device with virtual reality is given to the patients with a film of 18 minutes | Device | Virtual Reality Neutral, Virtual reality Anxiety |
Primary outcome
impact of the virtual reality on the pregnancy rate (Ultrasound)
Time frame: 12 weeks
measured by ultrasound
4 secondary outcomes
impact of the virtual reality on anxiety (numeric scale)
Time frame: immediate
impact of the virtual reality on satisfaction
Time frame: immediate
impact of the virtual reality on pregnancy test
Time frame: 6 weeks
state-trait Anxiety Inventory
Time frame: immediate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
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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.
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 Anxiety and in Vitro Fertilization, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Mar 2018. 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 Belgium. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
impact of the virtual reality on the pregnancy rate (Ultrasound) (time frame: 12 weeks). 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 22 Mar 2018.