PainVIREVNCT05742971
Virtual Reality; the Effect on Pain Reduction During an External Version.
A study testing Virtual reality intervention performed through the Oculuc Go VR glasses in people with Pain, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
SUMMARY Rationale: The use of an external cephalic version (ECV) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pain
- What is being tested?
- Virtual reality intervention performed through the Oculuc Go VR glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Nov 2020to 31 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Singleton pregnancy in breech position
- Scheduled ECV
Who cannot join
- Contraindication for ECV
- Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' [16]. The pain is not due to an obstetrical problem.
- Chronic use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness
- Epileptic insults in previous history
Show all 14Show fewer
- Psychotically seizures in previous history
- Claustrophobic
- Blindness
- History of mental illness
- Patients in strict isolation (MRSA)
- Age <18 years
- Twin pregnancy
- No native Dutch speaker
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality; the Effect on Pain Reduction During an External Version, a Randomised Controlled Trial
SUMMARY
Rationale: The use of an external cephalic version (ECV) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections. Literature about the effectivity of virtual reality (VR) on acute pain reduction seems promising.
Read more
Objective: The primary objective of this study is to explore the effect of VR on pain during ECV. Secondary objectives are the rate of successful ECV procedures and to explore tolerability, feasibility and patient satisfaction of VR use.
Study design: The study concerns a non-blinded, single centre, randomised controlled trial.
Study population: Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen.
Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.
Main study parameters/endpoints: The primary outcome is pain measured on a numeric rating scale (NRS). A total of 42 patients have to be included in each group. This means that a total of 84 women will have to be included in the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score (NRS). The study population experiences a very small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.
- Conditions
- Pain
- Being tested
- Virtual reality intervention performed through the Oculuc Go VR glasses
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual reality intervention performed through the Oculuc Go VR glassesDevice
The participants randomised into this group are offered a VR intervention during the external version for 5-10 minutes in addition to the standard care of an ECV. The VR is performed through the Oculus Go VR glasses. These women can choose for an immersive guided relaxation VR experience or an interactive VR experience (see descriptions below). The ECV expert executing the ECV will register immediately after the ECV which option the patients has chosen. Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. After the ECV procedure, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated.
| Study group | Role | What they receive |
|---|---|---|
| VR group | Experimental | The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. After the ECV procedure, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated. Receives: Device: Virtual reality intervention performed through the Oculuc Go VR glasses |
| Standard care group | No intervention | The participants randomised to the standard care group receive the usual standard care given during external version.Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of pain during ECV when using VR (VAS, visual analogue scale)
pain score by VAS visual analogue scale minimum 0-maximum 10 (higher score is a worse outcome).
Measured: 15 minutes
Secondary outcomes (2)
Rate of successful ECV procedures
Measured: 15 minutes
Patient tolerability, feasibility and satisfaction of VR use (questionnaire)
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start19 Nov 2020
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies 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
- Model description
- The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- M Wassen, Dr, Principal investigator, Zuyderland MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05742971
- Sponsor's protocol ID
- NL-71484.096.19
- Acronym
- VIREV
- Status last verified
- Feb 2023
- First submitted
- 9 Feb 2023
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality; the Effect on Pain Reduction During an External Version, a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05742971
- Acronym / sponsor ID
- VIREV / NL-71484.096.19
- Conditions
- Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 24 Feb 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.
SUMMARY
Rationale: The use of an external cephalic version (ECV) to rotate the fetus from a non-cephalic to cephalic presentation reduces the rate of caesarean section by approximately two-thirds in term pregnancies with breech presentation. Reducing pain during external cephalic version can contribute to an increase in success rate and consequently reduce the number of cesarean sections. Literature about the effectivity of virtual reality (VR) on acute pain reduction seems promising.
Objective: The primary objective of this study is to explore the effect of VR on pain during ECV. Secondary objectives are the rate of successful ECV procedures and to explore tolerability, feasibility and patient satisfaction of VR use.
Study design: The study concerns a non-blinded, single centre, randomised controlled trial.
Study population: Eligible women who fulfill the inclusion criteria and are scheduled for an external cephalic version in the Zuyderland Medical Centre location Heerlen.
Intervention: The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.
Main study parameters/endpoints: The primary outcome is pain measured on a numeric rating scale (NRS). A total of 42 patients have to be included in each group. This means that a total of 84 women will have to be included in the study.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Each participating woman is asked to complete a questionnaire after using VR and the degree of pain perception is questioned on the basis of a 0-10 score (NRS). The study population experiences a very small medical risk when participating to this study. They can experience side-effects of VR for example dizziness or nausea and in rare cases epileptic insults.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- The study population will be randomly divided into the intervention group (VR-group) or the standard care group. The intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version additional to the usual standard care. The participants randomised to the standard care group receive the usual standard care given during external version.
| Arm | Type | Receives |
|---|---|---|
| VR group | Experimental | Device: Virtual reality intervention performed through the Oculuc Go VR glassesThe intervention group can choose for an immersive guided relaxation VR experience or an interactive VR experience during the external version Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. After the ECV procedure, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated. |
| Standard care group | No intervention | –The participants randomised to the standard care group receive the usual standard care given during external version.Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Singleton pregnancy in breech position
- Scheduled ECV
Key exclusion criteria (14 listed)
- Contraindication for ECV
- Chronic pain patients defined as 'persistent or recurrent pain lasting longer than 3 months' [16]. The pain is not due to an obstetrical problem.
- Chronic use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness
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 intervention performed through the Oculuc Go VR glassesThe participants randomised into this group are offered a VR intervention during the external version for 5-10 minutes in addition to the standard care of an ECV. The VR is performed through the Oculus Go VR glasses. These women can choose for an immersive guided relaxation VR experience or an interactive VR experience (see descriptions below). The ECV expert executing the ECV will register immediately after the ECV which option the patients has chosen. Immediately after the external version, a pain measurement is taken with regard to the pain during the ECV by means of the NRS score. After the ECV procedure, participants of the VR-group receive a structured questionnaire in which tolerability, feasibility and satisfaction of VR use is evaluated. | Device | VR group |
Primary outcome
Change of pain during ECV when using VR (VAS, visual analogue scale)
Time frame: 15 minutes
pain score by VAS visual analogue scale minimum 0-maximum 10 (higher score is a worse outcome).
2 secondary outcomes
Rate of successful ECV procedures
Time frame: 15 minutes
Patient tolerability, feasibility and satisfaction of VR use (questionnaire)
Time frame: 15 minutes
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 20 Aug 2024.
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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.
M Wassen, Dr principal investigator
Zuyderland MC
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 intervention performed through the Oculuc Go VR glasses in people with Pain, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
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 5 inclusion and 14 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 20 Aug 2024. 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 Netherlands. 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?
Change of pain during ECV when using VR (VAS, visual analogue scale) (time frame: 15 minutes). 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 20 Aug 2024.