Pain, PostoperativeOPU-LUXNCT05830513
OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up
A study testing Virtual Reality in people with Pain, Postoperative and IVF, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, IVF
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2023to 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 to 43 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 43 years
- IVF with follicular aspiration of one to tree follicles
- Written informed consent signed by the participant must be obtained prior to OPU
Who cannot join
- OPU with more than tree follicular aspiration
- Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV)
- Application of analgesics within eight hours before OPU
- hearing impairments
- migraines
- seizure disorder
- vestibular abnormalities
- history of motion sickness
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
PD. Dr. med. Kohl Schwartz, Alexandra
Lucerne, 6000
Angela Vidal
Lea Schumpf
About this study
Official title: OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial
In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.
- Conditions
- Pain, Postoperative, IVF
- Being tested
- Virtual Reality
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
Women will be randomly allocated to undergo OPU either with the use of virutal reality (group A) or the control group with standard treatment, without analgesia(group B). The participants of group A will wear the Oculus Quest 2 and will be surrounded by a virtual world. They will see objects flying towards themselves. They will be able to interact with the virtual world by hand controllers and can try to catch the objects.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | Women will be randomly allocated to undergo OPU either with the use of Virtual reality(group A) Receives: Device: Virtual Reality |
| Group B | No intervention | Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B). |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS
visual analogue scale pain scoring
Measured: post OPU (line from 0: no pain to 10:worst pain) immediately post OPU
Secondary outcomes (5)
VAS for anxiety
VAS for anxiety
Measured: Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU
state-trait anxiety inventory form (STAI)
state-trait anxiety inventory form (STAI)
Measured: Pre-OPU
vital parameters: pulse rate
vital parameters : pulse rate
Measured: Intraoperative
vital parameters: blood pressure
vital parameters: blood pressure (systolic and diastolic pressures)
Measured: Intraoperative
vital parameters : oxygen saturation
vital parameters : oxygen saturation
Measured: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830513
- Sponsor's protocol ID
- OPU-LUX
- Acronym
- OPU-LUX
- Status last verified
- Mar 2023
- First submitted
- 14 Mar 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPU-LUX: Virtual Reality for Pain and Anxiety Management During Oocyte Pick-up - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05830513
- Acronym / sponsor ID
- OPU-LUX / OPU-LUX
- Conditions
- Pain, Postoperative, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 26 Apr 2023 (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.
In vitro fertilization (IVF) cycles are increasingly performed worldwide. Transvaginal oocyte pick-up (OPU) is a painful part of IVF. OPU in polyfollicular IVF is usually performed under sedation and pain relief. In natural cycle IVF or IVF with minimal stimulation OPU is possible without anesthesia. Mostly of the women reported experiencing mild to moderate pain when undergoing OPU without anesthesia. Nevertheless, there is a need for alternative pain treatment options during OPU to reduce the burden of IVF for patients. Virtual reality (VR) may have a role in acutely painful procedures as a non-pharmacological alternative. VR refers to the interactions between an individual and a computer-generated environment stimulating multiple sensory modalities. The immersive, entertaining effects of VR could be useful for redirecting the patient's attention away from painful treatment experiences and reducing anxiety, discomfort, or unpleasantness. Use of VR interventions has been studies in a wider range of medical treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Device: Virtual RealityWomen will be randomly allocated to undergo OPU either with the use of Virtual reality(group A) |
| Group B | No intervention | –Women will be randomly assigned to an OPU in the control group with standard treatment, withouth analgesia (Group B). |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age between 18 and 43 years
- IVF with follicular aspiration of one to tree follicles
- Written informed consent signed by the participant must be obtained prior to OPU
Key exclusion criteria (8 listed)
- OPU with more than tree follicular aspiration
- Individuals' anatomy complicating the intervention (e. g. endometriosis stage III/IV)
- Application of analgesics within eight hours before OPU
- hearing impairments
- migraines
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 RealityWomen will be randomly allocated to undergo OPU either with the use of virutal reality (group A) or the control group with standard treatment, without analgesia(group B). The participants of group A will wear the Oculus Quest 2 and will be surrounded by a virtual world. They will see objects flying towards themselves. They will be able to interact with the virtual world by hand controllers and can try to catch the objects. | Device | Group A |
Primary outcome
VAS
Time frame: post OPU (line from 0: no pain to 10:worst pain) immediately post OPU
visual analogue scale pain scoring
5 secondary outcomes
VAS for anxiety
Time frame: Pre-post OPU (line from 0: no to 10:worst anxiety) pre- und immediately post OPU
state-trait anxiety inventory form (STAI)
Time frame: Pre-OPU
vital parameters: pulse rate
Time frame: Intraoperative
vital parameters: blood pressure
Time frame: Intraoperative
vital parameters : oxygen saturation
Time frame: Intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: Undecided
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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 Pain, Postoperative and IVF, run by Luzerner Kantonsspital at 1 site in Switzerland.
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 3 inclusion and 8 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 26 Apr 2023. 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 Switzerland. 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?
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?
VAS (time frame: post OPU (line from 0: no pain to 10:worst pain) immediately post OPU). 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 26 Apr 2023.