Virtual RealityNCT05187247
VR Glasses During Induction of Labour for Pain and Anxiety Relieve
A study testing Virtual Reality glasses in people with Virtual Reality and Induction of Labor Affected Fetus / Newborn, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Virtual Reality, Induction of Labor Affected Fetus / Newborn, Extra Amniotic Balloon
- 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
- 145 participants
- Where
- 1 siteIsrael
- Study dates
- 23 Nov 2021to 31 May 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant women going through mechanical induction of labour with Extra-Amniotic Balloon
Who cannot join
- Women with history of migraine, headache, epilepsy, vestibular disorders
- Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Wolfson Medical Center
Holon
Ilia Kleiner, MD, 972528305195, kleiner.ilia@gmail.com
About this study
Official title: Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial
In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter
Read the detailed description
Insertion of Extra-Amniotic Balloon (EAB) is a recommend mechanical method of Induction of labour. This method of induction causes the cervix to dilate through mechanical pressure on the cervix.
During the procedure of insertion the women is lying on her back. Insertion of EAB is performed by conventional means.
The insertion of EAB can involve discomfort, pain and anxiety before and during the procedure.
While there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period.
The "Virtual Reality" (VR) technology is a simple non-invasive technology. The advantage of VR is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. This technology uses processes of sight, and hearing that requires attention.
Many studies have already investigated the use of VR technology in various medical procedures, such as dental treatment, infusion, pediatric treatment, burns, trauma, chemotherapy, diagnostic hysteroscopies and other medical procedures that are common to the patient's experience of pain and anxiety.
- Being tested
- Virtual Reality glasses
- Keywords
- Virtual reality, Induction of Labor, Extra amniotic Balloon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality glassesDevice
use of virtual reality glasses to reduce anxiety and pain levels
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure Receives: Device: Virtual Reality glasses |
| control group | No intervention | control group for the intervention group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in pain severity
Subjective assessment of the degree of pain would be graded according to the VAS (Visual Analogue Scale) which is a scale used to measure subjective pain intensity according to a pain scale of 0 to 10, An objective pain assessment will be performed by measuring a pulse at a predetermined time points.
Measured: 1 hour
Secondary outcomes (1)
Change in Anxiety state
Anxiety levels will be measured by a valid questionnaire for assessing situational anxiety called The State-Trait Anxiety Inventory (STAI: Y). This version includes 20 statements which represents feelings that characterize anxiety. Women will be asked to rate them on a scale between 1 to 4. The final score in each questionnaire is obtained by summarizing all the ratings. A higher score indicates a higher level of anxiety.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2022
- Study start23 Nov 2021
- Primary completion1 Nov 2022 (estimated)
- Study completion31 May 2023 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A pregnant women who is designated for induction of labor using an extra-amniotic balloon catheter will complete a STAI questionnaire about the degree of anxiety prior to the procedure. All women then will be randomly assigned to 2 groups according to a randomization table. Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure while the second group will constitute a control group for the intervention group. During the insertion procedure, a subjective assessment of the degree of pain will be performed using VAS score (Visual Analog Scale), and objective pain assessment which will be performed by measuring a pulse at a predetermined time points. At the end of the procedure the women will be asked to answer another anxiety questionnaire. Women in the VR group will also answer a satisfaction questionnaire from the experience
- Masking
- None (open label)
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ilia kleiner, Wolfson Medical Center
- Investigators
- ilia kleiner, MD, Principal investigator, Wolfson Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187247
- Sponsor's protocol ID
- 0156-21-WOMC
- Status last verified
- Jan 2022
- First submitted
- 23 Nov 2021
- Last updated
- 27 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
PubMed 22419342Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097.
PubMed 30175373Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
PubMed 23277857Kleiner I, Mor L, Friedman M, Abeid AA, Shoshan NB, Toledano E, Bar J, Weiner E, Barda G. The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief-a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101222. doi: 10.1016/j.ajogmf.2023.101222. Epub 2023 Nov 10.
PubMed 37951577
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Glasses During Extra-Amniotic Balloon Insertion for Pain and Anxiety Relieve - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05187247
- Acronym / sponsor ID
- 0156-21-WOMC
- Keywords
- Virtual reality, Induction of Labor, Extra amniotic Balloon
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 23 Nov 2021 (actual)
- Primary completion
- 1 Nov 2022 (estimated)
- Study completion
- 31 May 2023 (estimated)
- First posted
- 11 Jan 2022 (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.
In the current study, The investigators aim is to test the distraction affect of "Virtual Reality" (VR) technology on pain and anxiety in pregnant women who undergo through an induction of labour with an extra-amniotic balloon catheter
Detailed description
Insertion of Extra-Amniotic Balloon (EAB) is a recommend mechanical method of Induction of labour. This method of induction causes the cervix to dilate through mechanical pressure on the cervix.
During the procedure of insertion the women is lying on her back. Insertion of EAB is performed by conventional means.
The insertion of EAB can involve discomfort, pain and anxiety before and during the procedure.
While there are numerous studies which describe interventional, pharmacological and non-pharmacological means for pain and anxiety relieve during latent and active phase of labour, there is no sufficient evidence for pain and anxiety relieve during the pre-labour and through induction of labour period.
The "Virtual Reality" (VR) technology is a simple non-invasive technology. The advantage of VR is that it can distract the patient's attention from pain and anxiety by exposure to a virtual reality environment. This technology uses processes of sight, and hearing that requires attention.
Many studies have already investigated the use of VR technology in various medical procedures, such as dental treatment, infusion, pediatric treatment, burns, trauma, chemotherapy, diagnostic hysteroscopies and other medical procedures that are common to the patient's experience of pain and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A pregnant women who is designated for induction of labor using an extra-amniotic balloon catheter will complete a STAI questionnaire about the degree of anxiety prior to the procedure. All women then will be randomly assigned to 2 groups according to a randomization table. Women assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure while the second group will constitute a control group for the intervention group. During the insertion procedure, a subjective assessment of the degree of pain will be performed using VAS score (Visual Analog Scale), and objective pain assessment which will be performed by measuring a pulse at a predetermined time points. At the end of the procedure the women will be asked to answer another anxiety questionnaire. Women in the VR group will also answer a satisfaction questionnaire from the experience
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual Reality glassesWomen assigned to the VR group will use the "virtual reality" technology throughout the insertion procedure |
| control group | No intervention | –control group for the intervention group |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pregnant women going through mechanical induction of labour with Extra-Amniotic Balloon
Key exclusion criteria (2 listed)
- Women with history of migraine, headache, epilepsy, vestibular disorders
- Women suffering from seasickness ,motion sickness, vertigo, nausea, vomiting, seizures
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 glassesuse of virtual reality glasses to reduce anxiety and pain levels | Device | VR group |
Primary outcome
Change in pain severity
Time frame: 1 hour
Subjective assessment of the degree of pain would be graded according to the VAS (Visual Analogue Scale) which is a scale used to measure subjective pain intensity according to a pain scale of 0 to 10, An objective pain assessment will be performed by measuring a pulse at a predetermined time points.
1 secondary outcome
Change in Anxiety state
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2022.
- Background: PubMed 22419342Jones L, Othman M, Dowswell T, Alfirevic Z, Gates S, Newburn M, Jordan S, Lavender T, Neilson JP. Pain management for women in labour: an overview of systematic reviews. Cochrane Database Syst Rev. 2012 Mar 14;2012(3):CD009234. doi: 10.1002/14651858.CD009234.pub2.
- Background: PubMed 30175373Lim SE, Tan TL, Ng GYH, Tagore S, Kyaw EEP, Yeo GSH. Patient satisfaction with the cervical ripening balloon as a method for induction of labour: a randomised controlled trial. Singapore Med J. 2018 Aug;59(8):419-424. doi: 10.11622/smedj.2018097.
- Background: PubMed 23277857Asl Aminabadi N, Erfanparast L, Sohrabi A, Ghertasi Oskouei S, Naghili A. The Impact of Virtual Reality Distraction on Pain and Anxiety during Dental Treatment in 4-6 Year-Old Children: a Randomized Controlled Clinical Trial. J Dent Res Dent Clin Dent Prospects. 2012 Fall;6(4):117-24. doi: 10.5681/joddd.2012.025. Epub 2012 Nov 12.
- Derived from this study: PubMed 37951577Kleiner I, Mor L, Friedman M, Abeid AA, Shoshan NB, Toledano E, Bar J, Weiner E, Barda G. The use of virtual reality during extra-amniotic balloon insertion for pain and anxiety relief-a randomized controlled trial. Am J Obstet Gynecol MFM. 2024 Jan;6(1):101222. doi: 10.1016/j.ajogmf.2023.101222. Epub 2023 Nov 10.
- 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.
ilia kleiner, MD principal investigator
Wolfson Medical Center
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 Virtual Reality and Induction of Labor Affected Fetus / Newborn, run by Wolfson 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 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 27 Jan 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?
Contact ilia kleiner, MD (972528305195, kleiner.ilia@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain severity (time frame: 1 hour). 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 NCT05187247, 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 27 Jan 2022.