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Use of Virtual Reality in Active Labor

Use of Virtual Reality in Active Labor

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04862039
Enrollment
30
Registered
2021-04-27
Start date
2021-05-01
Completion date
2021-10-01
Last updated
2021-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Brief 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. 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.

Interventions

DEVICEVirtual Reality (VR) devices

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.

Sponsors

Federico II University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* singleton gestations; * term pregnancy * spontaneous labor * diagnosis of active phase of labor; * nulliparous between 37 and 42 gestation weeks with cephalic presentation ;

Exclusion criteria

* multiple gestations; * preterm labor; * preterm premature rupture of membranes * induction to delivery labor; * hipertensive disorders; * fetal abnormalities; * 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.

Design outcomes

Primary

MeasureTime frameDescription
Subjective pain during the active phaseduring the active phase of labor up to 10 cmwomen pain using visual analogue scale (VAS)

Secondary

MeasureTime frameDescription
nauseaduring the active phase of labor (i.e. after 4-6 cm of dilatation)nausea referred by the patient and episodes of vomiting
anxietyduring the active phase of labor (i.e. after 4-6 cm of dilatation)women axneity using visual analogue scale (VAS)
Incidence of episiotomyat the time of deliveryIncidence of episiotomy

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026