Use of Virtual Reality in Active Labor

NCT ID: NCT04862039

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2021-10-01

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.

Conditions

Labor Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Virtual Reality (VR) devices

intervention group (VR).

Group Type: EXPERIMENTAL

Virtual Reality (VR) devices

Intervention Type: DEVICE

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.

control group

the standard of care (control group, no VR)

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Gabriele Saccone

PI MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gabriele Saccone

Naples, , Italy

Countries

Italy

Other Identifiers

485/20

Identifier Type: -

Identifier Source: org_study_id