Infertility, FemaleNCT05826938
Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
A study testing Virtual reality technology in people with Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
Trial summary
A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval. The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Female
- What is being tested?
- Virtual reality technology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteDenmark
- Study dates
- 13 Mar 2023to 13 Mar 2024
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women undergoing oocyte retrieval
- Understanding and speaking Danish
Who cannot join
- Previous participation in the trial
- Acupuncture as pain relief during oocyte retrieval
Trial locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Fertility Clinic Skive, Skive Regional Hospital
Skive, 7800
Peter Humaidan, DMSc, +4578445760, fertilitetsklinikken@midt.rm.dk
About this study
A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval.
The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience
- Conditions
- Infertility, Female
- Being tested
- Virtual reality technology
- Keywords
- Infertility, Virtual reality
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality technologyDevice
Participants who are randomized to group 1 will receive the Virtual Reality glasses on the day of oocyte retrieval in the recovery room. The participant chooses which animation she wants to experience.
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | The intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment Receives: Device: Virtual reality technology |
| Control | No intervention | The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaires regarding impact on patient experience
The impact of Virtual Reality technology on the patient experience during oocyte retrieval through questionnaires.
A visual analog scale (VAS) from 1-10 will be used for this measurement.
Measured: 30-60 minutes
Secondary outcomes (1)
Questionnaires reagarding the impact on the consumption of analgesic medication
The effect of Virtual Reality technology on the consumption of analgesic medication.
A visual analog scale (VAS) from 1-10 will be used for this measurement.
Measured: 30-60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start13 Mar 2023
- Primary completion1 Mar 2024 (estimated)
- Study completion13 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, FemaleStudies 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
- 82 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peter Humaidan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Peter Humaidan, Regionshospitalet Viborg, Skive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826938
- Sponsor's protocol ID
- Virtual Reality-project
- Status last verified
- Apr 2023
- First submitted
- 8 Mar 2023
- Last updated
- 28 Apr 2023
- 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 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Virtual Reality Technology Improve the Patient Experience in Oocyte Retrieval?
- ClinicalTrials.gov ID
- NCT05826938
- Acronym / sponsor ID
- Virtual Reality-project
- Conditions
- Infertility, Female
- Keywords
- Infertility, Virtual reality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 82 participants (estimated)
- Lead sponsor
- Peter HumaidanUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 13 Mar 2024 (estimated)
- First posted
- 24 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.
A non-pharmacological, non-blinded, randomized cohort study that will investigate the effect of Virtual Reality technology on the patient experience during oocyte retrieval.
The primary objective of the trial is to investigate the impact of Virtual Reality technology on the patient experience
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: Virtual reality technologyThe intervention group receives stimuli in the form of Virtual Reality technology before and during oocyte retrieval. In addition, patients receive standard treatment |
| Control | No intervention | –The control group, does not receive stimuli in the form of Virtual Reality technology, but only the standard treatment |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women undergoing oocyte retrieval
- Understanding and speaking Danish
Key exclusion criteria (2 listed)
- Previous participation in the trial
- Acupuncture as pain relief during oocyte retrieval
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 reality technologyParticipants who are randomized to group 1 will receive the Virtual Reality glasses on the day of oocyte retrieval in the recovery room. The participant chooses which animation she wants to experience. | Device | Virtual reality |
Primary outcome
Questionnaires regarding impact on patient experience
Time frame: 30-60 minutes
The impact of Virtual Reality technology on the patient experience during oocyte retrieval through questionnaires. A visual analog scale (VAS) from 1-10 will be used for this measurement.
1 secondary outcome
Questionnaires reagarding the impact on the consumption of analgesic medication
Time frame: 30-60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
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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.
Fertility Clinic Skive, Skive Regional Hospital
Skive, Denmark
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 technology in people with Infertility, Female, run by Peter Humaidan at 1 site in Denmark.
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 2 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 28 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 Denmark. 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?
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?
Questionnaires regarding impact on patient experience (time frame: 30-60 minutes). 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 28 Apr 2023.