Virtual RealityVRNCT05941390
Using Virtual Reality (VR) Technology in Gynecological and Obstetrics Procedures
A study testing VR without positive psychology and VR with positive psychology in people with Virtual Reality and Anxiety, run by Assuta Ashdod Hospital.
Trial summary
A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. 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
- Virtual Reality, Anxiety, Pain
- What is being tested?
- VR without positive psychology and VR with positive psychology
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Sep 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
- amniocintesis -single tone,gestional age 16-24 week,
- hysteroscopy-women age 18-60 , diagnostic procedure,
Who cannot join
- ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
- amniocintesis- Known fetal malformations, amnionitis
- hysteroscopy-pregnancy, PID
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Using Virtual Reality (VR) Technology in Gynecological Procedures
A randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.
After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.
Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.
- Conditions
- Virtual Reality, Anxiety, Pain
- Being tested
- VR without positive psychology, VR with positive psychology
- Medical subject headings
- Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR without positive psychologyDevice
Using VR goggles showing relaxing short videos without sound
VR with positive psychologyDevice
Using VR goggles showing relaxing short videos with positive psychological messages
| Study group | Role | What they receive |
|---|---|---|
| control | No intervention | patients undergoing one of the procedures without using VR device |
| VR without sound | Active comparator | patients undergoing one of the procedures using VR device without sound Receives: Device: VR without positive psychology |
| VR with sound | Active comparator | patients undergoing one of the procedures using VR device with sound Receives: Device: VR with positive psychology |
What is being measured
The primary outcome is the main question the study is designed to answer.
stress cortisol saliva level
each arm after the procedure will be mesured stress cortisol level in saliva
Measured: up to 5 minutes after the procedure
Secondary outcomes (2)
pain levels
each arm after the procedure will fill pain questioner. pain questioners using visual analog score. 0- to 10, while 0 is no pain at all, 10 is the worse pain ever felt.the patients will fill the questioner before and after the procedures.
Measured: up to 5 minutes after
anxiety levels
each arm after the procedure will fill anxiety questioner. anxiety questioner using the short depression , anxiety and stress scale (DASS-21). the patients will fill the questioners before and after the procedures.
Measured: up to 5 minutes after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Virtual RealityStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assuta Ashdod Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Noa glick fishman, MD, Principal investigator, Assuta Ashdod
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05941390
- Sponsor's protocol ID
- 0125-22-AAA
- Acronym
- VR
- Status last verified
- Jun 2023
- First submitted
- 5 Jun 2023
- Last updated
- 3 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Koyyalamudi V, Sidhu G, Cornett EM, Nguyen V, Labrie-Brown C, Fox CJ, Kaye AD. New Labor Pain Treatment Options. Curr Pain Headache Rep. 2016 Feb;20(2):11. doi: 10.1007/s11916-016-0543-2.
PubMed 26780039Woolf CJ. What is this thing called pain? J Clin Invest. 2010 Nov;120(11):3742-4. doi: 10.1172/JCI45178. Epub 2010 Nov 1.
PubMed 21041955Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.
PubMed 31094789Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2.
PubMed 32485759
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Virtual Reality (VR) Technology in Gynecological Procedures
- ClinicalTrials.gov ID
- NCT05941390
- Acronym / sponsor ID
- VR / 0125-22-AAA
- Conditions
- Virtual Reality, Anxiety, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Assuta Ashdod HospitalUniversity, hospital or other
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Sep 2024 (estimated)
- First posted
- 12 Jul 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 randomized control trial will be conducted in Assuta Ashdod hospital, in the department of obstetrics and gynecology. Pregnant and non pregnant women, undergoing one of the procedures (external cephalic version,amniocentesis or hysteroscopy), will be approached. All willing patients meeting the criteria will sign an informed consent form will.
After signing informed consent patients will be randomly allocated into three groups:1) control (no use of VR). 2) use of VR googles without positive psychology. 3) use of VR googles with positive psychology.
Before and after the procedure each group will answer pain and anxiety questionnaires. In addition, following, following each procedure, salivary cortisol levels will be measured.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –patients undergoing one of the procedures without using VR device |
| VR without sound | Active comparator | Device: VR without positive psychologypatients undergoing one of the procedures using VR device without sound |
| VR with sound | Active comparator | Device: VR with positive psychologypatients undergoing one of the procedures using VR device with sound |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ECV- single tone, breech presentation,gestional age 35-40,unknown drug allergy
- amniocintesis -single tone,gestional age 16-24 week,
- hysteroscopy-women age 18-60 , diagnostic procedure,
Key exclusion criteria (3 listed)
- ECV-previous cesarian section, contruction,low known plt count ,premature rupture of membrane
- amniocintesis- Known fetal malformations, amnionitis
- hysteroscopy-pregnancy, PID
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 |
|---|---|---|
| VR without positive psychologyUsing VR goggles showing relaxing short videos without sound | Device | VR without sound |
| VR with positive psychologyUsing VR goggles showing relaxing short videos with positive psychological messages | Device | VR with sound |
Primary outcome
stress cortisol saliva level
Time frame: up to 5 minutes after the procedure
each arm after the procedure will be mesured stress cortisol level in saliva
2 secondary outcomes
pain levels
Time frame: up to 5 minutes after
anxiety levels
Time frame: up to 5 minutes after
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2023.
- Background: PubMed 26780039Koyyalamudi V, Sidhu G, Cornett EM, Nguyen V, Labrie-Brown C, Fox CJ, Kaye AD. New Labor Pain Treatment Options. Curr Pain Headache Rep. 2016 Feb;20(2):11. doi: 10.1007/s11916-016-0543-2.
- Background: PubMed 21041955Woolf CJ. What is this thing called pain? J Clin Invest. 2010 Nov;120(11):3742-4. doi: 10.1172/JCI45178. Epub 2010 Nov 1.
- Background: PubMed 31094789Frey DP, Bauer ME, Bell CL, Low LK, Hassett AL, Cassidy RB, Boyer KD, Sharar SR. Virtual Reality Analgesia in Labor: The VRAIL Pilot Study-A Preliminary Randomized Controlled Trial Suggesting Benefit of Immersive Virtual Reality Analgesia in Unmedicated Laboring Women. Anesth Analg. 2019 Jun;128(6):e93-e96. doi: 10.1213/ANE.0000000000003649.
- Background: PubMed 32485759Wong MS, Spiegel BMR, Gregory KD. Virtual Reality Reduces Pain in Laboring Women: A Randomized Controlled Trial. Am J Perinatol. 2021 Aug;38(S 01):e167-e172. doi: 10.1055/s-0040-1708851. Epub 2020 Jun 2.
- 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.
Noa glick fishman, MD principal investigator
Assuta Ashdod
Questions about this trial
What is this clinical trial studying?
A study testing VR without positive psychology and VR with positive psychology in people with Virtual Reality and Anxiety, run by Assuta Ashdod Hospital.
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 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 3 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
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 Noa glick fishman, MD (0544443952 ext. 972, noagl@assuta.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stress cortisol saliva level (time frame: up to 5 minutes after the procedure). 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 NCT05941390, which also lists 4 linked publications.
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 3 Aug 2023.