Labor PainVIRELNCT04858984
Virtual Reality, Experience During Labour; a Qualitative Research (VIREL)
A study testing Virtual Reality in people with Labor Pain and Virtual Reality, run by Zuyderland Medisch Centrum at 1 site in Netherlands.
Trial summary
Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain. 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
- Labor Pain, Virtual Reality, Analgesia
- What is being tested?
- Virtual Reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2020to 1 Mar 2021
- 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
- Pregnant of a singleton in cephalic presentation
- Intention to deliver vaginally
- Induced labour by a balloon or artificial rupture of membranes
Who cannot join
- Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months'. The pain is not due to the gynecological problem.
- Chronical use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness or susceptibility to motion sickness
- Epileptic insults in previous history
- Psychotically seizures in previous history
Show all 11Show fewer
- Claustrophobic
- Blindness
- History of mental illness
- Severe hearing or vision deficits
- Epidural Anesthesia during labour
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Virtual Reality, Experience During Labour; a Qualitative Research
Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.
The aim of this qualitative study is to explore the experience, preference, and satisfaction of the use of two different VR scenario's during labour. The secondary outcome parameter is the effect of VR on pain reduction and anxiety during labour, measured by NRS score.
Read the detailed description
Epidural Analgesia (EA) has been regarded as the most effective method of labour analgesia. Pharmacological analgesia methods are known to have adverse side effects, such as nausea, vomiting and drowsiness in parental opioids; pruritus, nausea, desaturation, respiratory depression and apnea in patient-controlled remifentanil analgesia; and maternal fever, maternal hypotension and urinary retention in EA. Furthermore, routine EA is likely resulting in more operative deliveries. Considering these possible adverse effects, it is worth exploring alternative methods for labour pain relief.
There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.
This VIREL study aims to examine the experience, preference, and satisfaction of VR in women during labour. The study is set up as a single centre, qualitative study in a non-university teaching hospital in The Netherlands with 2800 deliveries annually. Participants will experience an immersive guided relaxation VR (VR1) and an interactive game (VR2) during labour. VR1 consists of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 requires women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients are allowed to stop using the VR at any moment during the intervention.
When the participant is declared to be in labour, defined as having regular painful uterine contractions, cervical effacement and at least 3cm dilatation, VR1 will be offered for ten minutes. Before and immediately after VR1, the patient is asked to fill out a Numeric Rating Scale (NRS) score for pain.
During the 30-minute intermission after VR1 the patient fills out the post-intervention questionnaire regarding VR1. Subsequently, VR2 is offered for ten minutes. Before and immediately after VR2 the patient filled in the NRS score for pain, and the patient completed a post-intervention questionnaire regarding VR2. Additional use of VR is allowed by maternal request. Five days post-partum all participants who completed both VR interventions will be contacted by telephone for a semi-structured interview.
- Conditions
- Labor Pain, Virtual Reality, Analgesia, Pain
- Being tested
- Virtual Reality
- Keywords
- Virtual reality, labour pain, analgesia, obstetric care
- Medical subject headings
- Labor Pain, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual RealityDevice
A portable, standalone VR headset called Oculus Go (Facebook Technologies, LLC. 1601 Willow Road, Menlo Park, CA 940250) with a head-mounted display with built in audio drivers was used. Disposable hygiene masks and a surgical cap were used as an underlay below the headset an
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality group | Experimental | All participants experienced an immersive guided meditation virtual reality (VR1) and an interactive game virtual reality (VR2) experience during labour. Both VR interventions were offered for 10 minutes. Before and immediately after an intervention, the patient was asked to fill out a Numeric Rating Scale (NRS) score for pain.
During the 30-minute intermission after the VR intervention the patient completed the post-intervention questionnaire.
VR1 consisted of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 required women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients were allowed to stop using the VR at any moment during the intervention.
Five days post-partum all participants who completed both VR interventions were contacted by telephone for an interview. Receives: Device: Virtual Reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire.
A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0).
Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.
Measured: During labour: directly after the first VR intervention (Guided meditation VR)
Patients' VR experience, satisfaction and application preference (meditation or interactive game)
A patients' VR experience, satisfaction and application preference was examined using a semi-structured interview.
Theme's of the semi-structured interview:
- VR experience
- General experience
- VR1 experience
- VR2 experience
- Side effects
- Reusing VR
- Recommendation to other women
- Improvements 2 Pain reduction
- Pain intensity
- Pain perception
- Distraction 3 Usability VR application
- VR application
- Comfort of VR glasses
Measured: 5 days after labour
Patients' VR experience, satisfaction and application preference regarding the interactive game
A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire.
A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0).
Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.
Measured: During labour: directly after the first VR intervention (Interactive game)
Secondary outcomes (1)
Labour pain
Labour pain before and directly after VR was evaluated using the Numeric (pain) rating scale (The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain).)
Measured: 4 moments during labour: Before the first VR intervention (meditation), directly after the first VR intervention (meditation). Before the second VR intervention (game), directly after the second VR intervention (game).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start1 Jul 2020
- Primary completion12 Jan 2021
- Study completion1 Mar 2021
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 Labor 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
- Not applicable
- Intervention model
- Single group
- Model description
- Qualitative research
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zuyderland Medisch Centrum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne-Claire Musters, Zuyderland Medisch Centrum
- Investigators
- Martine Wassen, M.D., Principal investigator, Zuyderland MC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858984
- Sponsor's protocol ID
- NL-METCZ20200096
- Acronym
- VIREL
- Status last verified
- Apr 2021
- First submitted
- 11 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make individual participant data available at the moment. The study protocol, statistical analysis plan and informed consent form will be available after publication of the article.
Publications
Musters A, Vandevenne AS, Franx A, Wassen MMLH. Virtual Reality Experience during Labour (VIREL); a qualitative study. BMC Pregnancy Childbirth. 2023 Apr 24;23(1):283. doi: 10.1186/s12884-023-05432-9.
PubMed 37095433
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality, Experience During Labour; a Qualitative Research
- ClinicalTrials.gov ID
- NCT04858984
- Acronym / sponsor ID
- VIREL / NL-METCZ20200096
- Conditions
- Labor Pain, Virtual Reality, Analgesia, Pain
- Keywords
- Virtual reality, labour pain, analgesia, obstetric care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Zuyderland Medisch CentrumUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 1 Mar 2021 (actual)
- First posted
- 26 Apr 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.
Childbirth is associated with labour pain and can be regarded as one of the most serious kinds of pain. Labour pain management methods include pharmacological and non-pharmacological methods. There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.
The aim of this qualitative study is to explore the experience, preference, and satisfaction of the use of two different VR scenario's during labour. The secondary outcome parameter is the effect of VR on pain reduction and anxiety during labour, measured by NRS score.
Detailed description
Epidural Analgesia (EA) has been regarded as the most effective method of labour analgesia. Pharmacological analgesia methods are known to have adverse side effects, such as nausea, vomiting and drowsiness in parental opioids; pruritus, nausea, desaturation, respiratory depression and apnea in patient-controlled remifentanil analgesia; and maternal fever, maternal hypotension and urinary retention in EA. Furthermore, routine EA is likely resulting in more operative deliveries. Considering these possible adverse effects, it is worth exploring alternative methods for labour pain relief.
There is increasing evidence that virtual reality (VR) is effective in the reduction of labour pain.
This VIREL study aims to examine the experience, preference, and satisfaction of VR in women during labour. The study is set up as a single centre, qualitative study in a non-university teaching hospital in The Netherlands with 2800 deliveries annually. Participants will experience an immersive guided relaxation VR (VR1) and an interactive game (VR2) during labour. VR1 consists of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 requires women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients are allowed to stop using the VR at any moment during the intervention.
When the participant is declared to be in labour, defined as having regular painful uterine contractions, cervical effacement and at least 3cm dilatation, VR1 will be offered for ten minutes. Before and immediately after VR1, the patient is asked to fill out a Numeric Rating Scale (NRS) score for pain.
During the 30-minute intermission after VR1 the patient fills out the post-intervention questionnaire regarding VR1. Subsequently, VR2 is offered for ten minutes. Before and immediately after VR2 the patient filled in the NRS score for pain, and the patient completed a post-intervention questionnaire regarding VR2. Additional use of VR is allowed by maternal request. Five days post-partum all participants who completed both VR interventions will be contacted by telephone for a semi-structured interview.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Qualitative research
| Arm | Type | Receives |
|---|---|---|
| Virtual reality group | Experimental | Device: Virtual RealityAll participants experienced an immersive guided meditation virtual reality (VR1) and an interactive game virtual reality (VR2) experience during labour. Both VR interventions were offered for 10 minutes. Before and immediately after an intervention, the patient was asked to fill out a Numeric Rating Scale (NRS) score for pain. During the 30-minute intermission after the VR intervention the patient completed the post-intervention questionnaire. VR1 consisted of a video of an exotic location guided by the sound of the waves and a calm English-speaking voice. VR2 required women to use the controller to throw snowballs in order to catch presents and reach the next level. Patients were allowed to stop using the VR at any moment during the intervention. Five days post-partum all participants who completed both VR interventions were contacted by telephone for an interview. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Written and orally given informed consent
- 18 years and older
- Native Dutch speaker
- Pregnant of a singleton in cephalic presentation
- Intention to deliver vaginally
Key exclusion criteria (11 listed)
- Chronic pain patients; defined as 'persistent or recurrent pain lasting longer than 3 months'. The pain is not due to the gynecological problem.
- Chronical use of pain medication (opioids)
- Alcohol or drug abuse
- Known car sickness or susceptibility to motion sickness
- Epileptic insults in previous history
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 RealityA portable, standalone VR headset called Oculus Go (Facebook Technologies, LLC. 1601 Willow Road, Menlo Park, CA 940250) with a head-mounted display with built in audio drivers was used. Disposable hygiene masks and a surgical cap were used as an underlay below the headset an | Device | Virtual reality group |
Primary outcome
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR
Time frame: During labour: directly after the first VR intervention (Guided meditation VR)
A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire. A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0). Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.
Patients' VR experience, satisfaction and application preference (meditation or interactive game)
Time frame: 5 days after labour
A patients' VR experience, satisfaction and application preference was examined using a semi-structured interview. Theme's of the semi-structured interview: 1. VR experience * General experience * VR1 experience * VR2 experience * Side effects * Reusing VR * Recommendation to other women * Improvements 2 Pain reduction * Pain intensity * Pain perception * Distraction 3 Usability VR application * VR application * Comfort of VR glasses
Patients' VR experience, satisfaction and application preference regarding the interactive game
Time frame: During labour: directly after the first VR intervention (Interactive game)
A patients' VR experience, satisfaction and application preference was examined using a post-intervention questionnaire. A short post intervention questionnaire, intended to provide a first feedback about the experience and preference of the VR application the patient used a few minutes ago. Ratings varied of very pleasant (+5) versus very unpleasant (0) and very much (+5) versus not at all (0). Theme's: General experience of VR1 (meditation) / VR2 (game), the amount of distraction, feeling of anxiety during VR1 (meditation) / VR2 (game), reusing VR1 (meditation) / VR2 (game), preference of environment (beach environment or do you prefer something else?), side effects.
1 secondary outcome
Labour pain
Time frame: 4 moments during labour: Before the first VR intervention (meditation), directly after the first VR intervention (meditation). Before the second VR intervention (game), directly after the second VR intervention (game).
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 26 Apr 2021.
- Derived from this study: PubMed 37095433Musters A, Vandevenne AS, Franx A, Wassen MMLH. Virtual Reality Experience during Labour (VIREL); a qualitative study. BMC Pregnancy Childbirth. 2023 Apr 24;23(1):283. doi: 10.1186/s12884-023-05432-9.
- Individual participant dataSharing planned: No. There is no plan to make individual participant data available at the moment. The study protocol, statistical analysis plan and informed consent form will be available after publication of the article.
Related trials for Labor Pain
Recruiting
Pain Neuroscience-Based Education for Labor Pain in Pregnant Women
Labor Pain and Anxiety
Recruiting
The Effect of Breast Milk, 10% and 20% Dextrose on Pain and Physiological Variables During Heel Puncture in Infants
Newborn Care, Pain Management
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
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.
Martine Wassen, M.D. 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 in people with Labor Pain and Virtual Reality, 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 6 inclusion and 11 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 26 Apr 2021. 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?
Patients' VR experience, satisfaction and application preference regarding the guided meditation VR (time frame: During labour: directly after the first VR intervention (Guided meditation VR)). The study lists 3 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 NCT04858984, 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 26 Apr 2021.