Clinical trial NCT04862039: Use of Virtual Reality in Active Labor
Official title: Use of Virtual Reality in Active Labor
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Labor Pain
Lead sponsor: Federico II University
Sponsor class: OTHER
First posted: 2021-04-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Subjective pain during the active phase
timeFrame: "during the active phase of labor up to 10 cm"
Secondary outcomes:
measure: nausea
timeFrame: during the active phase of labor (i.e. after 4-6 cm of dilatation)
measure: anxiety
timeFrame: during the active phase of labor (i.e. after 4-6 cm of dilatation)
measure: Incidence of episiotomy
timeFrame: at the time of delivery
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Gabriele Saccone
Study officials:
References: