InfertilityNCT04625920
A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
A study testing SootheVR: AppliedVR, Los Angeles, California in people with Infertility and Vaginal Blood Loss, run by Tel-Aviv Sourasky Medical Center at 2 sites in Israel.
Trial summary
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy in the outpatient setting. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Vaginal Blood Loss
- What is being tested?
- SootheVR: AppliedVR, Los Angeles, California
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesIsrael
- Study dates
- 10 Apr 2020to 30 Sep 2020
- 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 75 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- . Women with suspected infection
- women considered not suitable to undergo an office hysteroscopy
- women who reported the use of analgesia 6 hours prior to the procedure.
Who cannot join
- patient needed office hysteroscopy
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Lis Maternity Hospital, Tel Aviv Sourasky Medical Center
Tel Aviv, 64239
Souraski MC
Tel Aviv
About this study
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy 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 operative hysteroscopy 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
- Infertility, Vaginal Blood Loss
- Being tested
- SootheVR: AppliedVR, Los Angeles, California
- Keywords
- Hysteroscopy, VR, Vurtual reality
- Medical subject headings
- Infertility, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SootheVR: AppliedVR, Los Angeles, CaliforniaDevice
a head-mounted display
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality | Experimental | women allocated to undergo hysteroscopy with Vr System Receives: Device: SootheVR: AppliedVR, Los Angeles, California |
| Standart care | Experimental | women allocated to undergo hysteroscopy without VR Receives: Device: SootheVR: AppliedVR, Los Angeles, California |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start10 Apr 2020
- Primary completion20 Sep 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, michal roll, Tel-Aviv Sourasky Medical Center
- Investigators
- eli shprecher, Prof, Study chair, souraski MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625920
- Sponsor's protocol ID
- 0793-19
- Status last verified
- Nov 2020
- First submitted
- 27 Oct 2020
- Last updated
- 12 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Virtual Reality System for Pain and Anxiety Management During Outpatient Hysteroscopy
- ClinicalTrials.gov ID
- NCT04625920
- Acronym / sponsor ID
- 0793-19
- Conditions
- Infertility, Vaginal Blood Loss
- Keywords
- Hysteroscopy, VR, Vurtual reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- 10 Apr 2020 (actual)
- Primary completion
- 20 Sep 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 12 Nov 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.
To evaluate the effectiveness of VR as a distraction technique in the management of acute pain and anxiety during operative hysteroscopy 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 operative hysteroscopy 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
- Treatment
- 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, Californiawomen allocated to undergo hysteroscopy with Vr System |
| Standart care | Experimental | Device: SootheVR: AppliedVR, Los Angeles, Californiawomen allocated to undergo hysteroscopy without VR |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- . Women with suspected infection
- women considered not suitable to undergo an office hysteroscopy
- women who reported the use of analgesia 6 hours prior to the procedure.
Key exclusion criteria (1 listed)
- patient needed office hysteroscopy
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, Californiaa head-mounted display | Device | Standart care, Virtual reality |
Primary outcome
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.
Assessments of pain through pain score parameter
Time frame: 10 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- 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.
eli shprecher, Prof study chair
souraski MC
2 sites 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 in people with Infertility and Vaginal Blood Loss, run by Tel-Aviv Sourasky Medical Center at 2 sites 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 3 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: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Assessments of pain through physiological parameters (time frame: 10 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?
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 12 Nov 2020.