Labor PainNCT04862039
Use of Virtual Reality in Active Labor
A study testing Virtual Reality (VR) devices in people with Labor Pain, run by Federico II University at 1 site in Italy.
Trial summary
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Virtual Reality (VR) devices
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 May 2021to 1 Oct 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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton gestations;
- term pregnancy
- spontaneous labor
- diagnosis of active phase of labor;
- nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
Who cannot join
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- hipertensive disorders;
- fetal abnormalities;
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- diabetes mellitus;
- intrauterine growth retardation;
- post-term pregnancy;
- multiple vaginal delivery;
- women with an altered state of consciousness, severely ill, mentally disabled;
- women with sight and/or hearing impairment;
- women at risk of epileptic seizures;
- women with predisposition to motion sickness;
- women under the age of 18 years or over the age of 45 years;
- Women who refuse to sign informed informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely. have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas.
Read the detailed description
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely.
For all these reasons, it is not surprising the interest in offering women valid non-invasive and cheaper options to relieve them from pain. As of today many alternative techniques have been proposed, many of which have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas. Recently Frey et al. have experimented in a pilot study the application of this technique to women during labor, obtaining interesting results. The authors of this study point, in the discussion of the scientific paper, to the necessity of developing virtual reality experiences more specific to labor and suggest different implementations, such as specific instructions for women (changes of position, breathing techniques) greater comfort (it is worth noticing the use on our side of exclusively wireless devices) and the implementation of the device with biofeedback.
In addition to learning from these suggestions, we tried to imagine VR in a different way: firstly as complementary, not alternative to the role of the midwife personnel, who will play a central role in our experimental treatment enriching the virtual reality scenario with their instructions, presence and motivational feedback; secondly we tried to imagine VR as a guide through labor, more than a alienation and distraction tool.
- Conditions
- Labor Pain
- Being tested
- Virtual Reality (VR) devices
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality (VR) devicesDevice
Virtual Reality (VR) devices. Subjects receiving the experimental treatment will be given a VR headset, headphones and wristband and the Philips wireless fetal-maternal monitoring system, after the necessary preparation of the abdominal skin.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality (VR) devices | Experimental | intervention group (VR). Receives: Device: Virtual Reality (VR) devices |
| control group | No intervention | the standard of care (control group, no VR) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective pain during the active phase
women pain using visual analogue scale (VAS)
Measured: "during the active phase of labor up to 10 cm"
Secondary outcomes (3)
nausea
nausea referred by the patient and episodes of vomiting
Measured: during the active phase of labor (i.e. after 4-6 cm of dilatation)
anxiety
women axneity using visual analogue scale (VAS)
Measured: during the active phase of labor (i.e. after 4-6 cm of dilatation)
Incidence of episiotomy
Incidence of episiotomy
Measured: at the time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 Aug 2021 (estimated)
- Study completion1 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriele Saccone, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04862039
- Sponsor's protocol ID
- 485/20
- Status last verified
- Apr 2021
- First submitted
- 22 Apr 2021
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: none planned
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Virtual Reality in Active Labor
- ClinicalTrials.gov ID
- NCT04862039
- Acronym / sponsor ID
- 485/20
- Conditions
- Labor Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 Aug 2021 (estimated)
- Study completion
- 1 Oct 2021 (estimated)
- First posted
- 27 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.
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely. have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas.
Detailed description
Labor is widely recognized as one of the most painful experience possible. The standard analgesic treatment currently consists of pharmacological methods. Adverse effects, complication risks, psychological effects, limit these techniques as well as high costs. These limits concurred to the application of these techniques mainly on demand and not routinely.
For all these reasons, it is not surprising the interest in offering women valid non-invasive and cheaper options to relieve them from pain. As of today many alternative techniques have been proposed, many of which have not, as of today, met a large scientific consensus, as shown by many recent Cochrane reviews. A promising perspective for non-pharmacological analgesia seems to be offered by Virtual Reality (VR) devices, which have been applied to many different medical areas. Recently Frey et al. have experimented in a pilot study the application of this technique to women during labor, obtaining interesting results. The authors of this study point, in the discussion of the scientific paper, to the necessity of developing virtual reality experiences more specific to labor and suggest different implementations, such as specific instructions for women (changes of position, breathing techniques) greater comfort (it is worth noticing the use on our side of exclusively wireless devices) and the implementation of the device with biofeedback.
In addition to learning from these suggestions, we tried to imagine VR in a different way: firstly as complementary, not alternative to the role of the midwife personnel, who will play a central role in our experimental treatment enriching the virtual reality scenario with their instructions, presence and motivational feedback; secondly we tried to imagine VR as a guide through labor, more than a alienation and distraction tool.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality (VR) devices | Experimental | Device: Virtual Reality (VR) devicesintervention group (VR). |
| control group | No intervention | –the standard of care (control group, no VR) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- singleton gestations;
- term pregnancy
- spontaneous labor
- diagnosis of active phase of labor;
- nulliparous between 37 and 42 gestation weeks with cephalic presentation ;
Key exclusion criteria (16 listed)
- multiple gestations;
- preterm labor;
- preterm premature rupture of membranes
- induction to delivery labor;
- hipertensive disorders;
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 (VR) devicesVirtual Reality (VR) devices. Subjects receiving the experimental treatment will be given a VR headset, headphones and wristband and the Philips wireless fetal-maternal monitoring system, after the necessary preparation of the abdominal skin. | Device | Virtual Reality (VR) devices |
Primary outcome
Subjective pain during the active phase
Time frame: "during the active phase of labor up to 10 cm"
women pain using visual analogue scale (VAS)
3 secondary outcomes
nausea
Time frame: during the active phase of labor (i.e. after 4-6 cm of dilatation)
anxiety
Time frame: during the active phase of labor (i.e. after 4-6 cm of dilatation)
Incidence of episiotomy
Time frame: at the time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No. none planned
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 (VR) devices in people with Labor Pain, run by Federico II University at 1 site in Italy.
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 16 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 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 Italy. 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?
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?
Subjective pain during the active phase (time frame: "during the active phase of labor up to 10 cm"). 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 27 Apr 2021.