Anxiety AcuteNCT04491149
Study on the Ability of Virtual Reality Glasses in Anxiety and Pain Reduction in 50 Women Undergoing Amniocentesis or Feticide
A study testing virtual reality glasses in people with Anxiety Acute and Amniocentesis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
Trial summary
Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Anxiety Acute, Amniocentesis, Foeticide
- What is being tested?
- virtual reality glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Sep 2020to Mar 2021
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Women younger than 18 years
- Twin pregnancies
- Women with vertigo
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Asaf ha Rofeh, MC
Zrifin, 70300
Ran Svirsky, Doctor of Medicine, +9729779000, rsvirs@gmail.com
Ran Svirsky, Doctor of Medicine
About this study
Official title: The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide
Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.
The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.
- Conditions
- Anxiety Acute, Amniocentesis, Foeticide
- Being tested
- virtual reality glasses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
virtual reality glassesDevice
In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.
| Study group | Role | What they receive |
|---|---|---|
| women using virtual glass during amniocentesis/foeticide | Experimental | Not described Receives: Device: virtual reality glasses |
| women undergoing amniocentesis/foeticide | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety level
Spielberger's State-Trait Anxiety Inventory
Measured: Up to one hour before the procedure
Anxiety level
Spielberger's State-Trait Anxiety Inventory
Measured: Up to one hour after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2020
- Study start1 Sep 2020
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety AcuteStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assaf-Harofeh Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04491149
- Sponsor's protocol ID
- #0182-19
- Status last verified
- May 2020
- First submitted
- 14 Jun 2020
- Last updated
- 27 Oct 2020
- 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 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ability of Virtual Reality in Anxiety and Pain Reduction in Women Undergoing Amniocentesis or Feticide
- ClinicalTrials.gov ID
- NCT04491149
- Acronym / sponsor ID
- #0182-19
- Conditions
- Anxiety Acute, Amniocentesis, Foeticide
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assaf-Harofeh Medical CenterOther government
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 29 Jul 2020 (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.
Both amniocenteses and especially feticide are procedures that incorporate both anxiety and pain. As anxiety and pain can be reduced when using a distraction, The investigators speculate that the use of virtual reality glasses during these procedures will elevate both anxiety and pain.
The investigators will examine this hypothesis by comparing two groups of participants who undergo amniocentesis or feticide, one group will undergo the procedure while using virtual reality glasses and the other without the use of the glasses.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| women using virtual glass during amniocentesis/foeticide | Experimental | Device: virtual reality glasses |
| women undergoing amniocentesis/foeticide | No intervention | – |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- Women younger than 18 years
- Twin pregnancies
- Women with vertigo
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 glassesIn the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure. | Device | women using virtual glass during amniocentesis/foeticide |
Primary outcome
Anxiety level
Time frame: Up to one hour before the procedure
Spielberger's State-Trait Anxiety Inventory
Anxiety level
Time frame: Up to one hour after the procedure
Spielberger's State-Trait Anxiety Inventory
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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 glasses in people with Anxiety Acute and Amniocentesis, run by Assaf-Harofeh Medical Center at 1 site in Israel.
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 0 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 27 Oct 2020. 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 Israel. 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?
Contact Ran Svirsky, MD (972-89779000, rsvirs@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety level (time frame: Up to one hour before the procedure). The study lists 2 primary outcomes in all. 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 27 Oct 2020.