Chronic PainNCT04711408
Virtual Reality During Ultrasound Examination of Women With Endometriosis
A study testing SootheVR: AppliedVR, Los Angeles, California a head-mounted displa in people with Chronic Pain and Pelvic Pain, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Chronic Pain, Pelvic Pain, Endometriosis
- What is being tested?
- SootheVR: AppliedVR, Los Angeles, California a head-mounted displa
- 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
- 14 Jun 2022to 1 Dec 2023
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.
Who cannot join
- women who reported the use of analgesia 6 hours prior to the procedure
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Aviad Cohen, MD, 972-547333450, co.aviad@gmail.com
eli shprecher, prof.
About this study
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.
Read the detailed description
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
- Conditions
- Chronic Pain, Pelvic Pain, Endometriosis
- Being tested
- SootheVR: AppliedVR, Los Angeles, California a head-mounted displa
- Medical subject headings
- Chronic Pain, Pelvic Pain, Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SootheVR: AppliedVR, Los Angeles, California a head-mounted displaDevice
For the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be "swimming with dolphins".
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | women allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System Receives: Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted displa |
| Standart care | No intervention | women allocated to undergo ultrasound for the diagnosis of endometriosis without VR |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessments of pain through pain score parameter
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Measured: 20 minutes
Assessments of pain through physiological parameters
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start14 Jun 2022 (estimated)
- Primary completion1 Jun 2023 (estimated)
- Study completion1 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711408
- Sponsor's protocol ID
- 0602-20-TLV
- Status last verified
- Jun 2022
- First submitted
- 3 Jan 2021
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohen A, Levin I, Cohen Y, Gil Y, Feldman N, Bar-On S, Krajden N, Nagar R. Virtual Reality for Pain Reduction During Transvaginal Ultrasound in Women With Endometriosis: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2026 Apr 19:S1553-4650(26)00243-8. doi: 10.1016/j.jmig.2026.04.013. Online ahead of print.
PubMed 42013933
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality During Ultrasound Examination of Women With Endometriosis
- ClinicalTrials.gov ID
- NCT04711408
- Acronym / sponsor ID
- 0602-20-TLV
- Conditions
- Chronic Pain, Pelvic Pain, Endometriosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 14 Jun 2022 (estimated)
- Primary completion
- 1 Jun 2023 (estimated)
- Study completion
- 1 Dec 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during ultrasound exam in patients with endometriosis in the outpatient setting.
Detailed description
A prospective, open-label, randomized control trial in a tertiary university-affiliated medical center between April to August 2020. Overall, 100 women will be randomly allocated to undergo ultrasound exam either with the use of VR (study group) or with standard treatment (control group). The primary outcome measures includ self-reported pain, anxiety scores, and vital parameters as pulse rate (PR) and respiratory rate (RR). Pain and anxiety outcomes were measured as numeric rating scores.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual reality | Experimental | Device: SootheVR: AppliedVR, Los Angeles, California a head-mounted displawomen allocated to undergo ultrasound for the diagnosis of endometriosis with Virtual reality System |
| Standart care | No intervention | –women allocated to undergo ultrasound for the diagnosis of endometriosis without VR |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- patient needed ultrasound with the diagnosis of endometriosis. the diagnosis of endometriosis is based on ultrasound finding or previous surgery.
Key exclusion criteria (1 listed)
- women who reported the use of analgesia 6 hours prior to the procedure
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 |
|---|---|---|
| SootheVR: AppliedVR, Los Angeles, California a head-mounted displaFor the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be "swimming with dolphins". | Device | Virtual reality |
Primary outcome
Assessments of pain through pain score parameter
Time frame: 20 minutes
Assessments of pain through pain score parameter of the NRS questionnaire. Pain will be measured using the Numeric Rating Scale (NRS) which is a 11 point scale from 0 to 10 which is a validated score of measuring pain and anxiety in which 0 is no pain and 10 is the worst imaginable pain and or anxiety.
Assessments of pain through physiological parameters
Time frame: 10 minutes
Assessments of pain through physiological parameters of pulse rate. Heart Rate will be measured using Heart Rate-beats per minute.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 42013933Cohen A, Levin I, Cohen Y, Gil Y, Feldman N, Bar-On S, Krajden N, Nagar R. Virtual Reality for Pain Reduction During Transvaginal Ultrasound in Women With Endometriosis: A Randomized Controlled Trial. J Minim Invasive Gynecol. 2026 Apr 19:S1553-4650(26)00243-8. doi: 10.1016/j.jmig.2026.04.013. Online ahead of print.
- 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.
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SootheVR: AppliedVR, Los Angeles, California a head-mounted displa in people with Chronic Pain and Pelvic Pain, run by Tel-Aviv Sourasky 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 1 inclusion and 1 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 14 Jun 2022. 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?
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?
Assessments of pain through pain score parameter (time frame: 20 minutes). 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?
On the ClinicalTrials.gov record for NCT04711408, which also lists 1 linked publication.
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 14 Jun 2022.