Use of Virtual Reality in Active Labor

Labor Pain Clinical Trial

Official title:

Use of Virtual Reality in Active Labor

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04862039
• Other study ID #: 485/20
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: October 1, 2021

Study information

• Verified date: April 2021
• Source: Federico II University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: October 1, 2021
• Est. primary completion date: August 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• Virtual 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.

Locations

Country	Name	City	State
Italy	Gabriele Saccone	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective pain during the active phase	women pain using visual analogue scale (VAS)	"during the active phase of labor up to 10 cm"
Secondary	nausea	nausea referred by the patient and episodes of vomiting	during the active phase of labor (i.e. after 4-6 cm of dilatation)
Secondary	anxiety	women axneity using visual analogue scale (VAS)	during the active phase of labor (i.e. after 4-6 cm of dilatation)
Secondary	Incidence of episiotomy	Incidence of episiotomy	at the time of delivery