Use of Virtual Reality in Active Labor

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Labor Pain
• Intervention / Treatment: Device: Virtual Reality (VR) devices

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Naples, Italy, 80100
    • Gabriele Saccone

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality (VR) devices; intervention group (VR).	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.
No Intervention: control group; the standard of care (control group, no VR)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective pain during the active phase	women pain using visual analogue scale (VAS)	"during the active phase of labor up to 10 cm"

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
nausea	nausea referred by the patient and episodes of vomiting	during the active phase of labor (i.e. after 4-6 cm of dilatation)
anxiety	women axneity using visual analogue scale (VAS)	during the active phase of labor (i.e. after 4-6 cm of dilatation)
Incidence of episiotomy	Incidence of episiotomy	at the time of delivery

Collaborators and Investigators

• Sponsor: Federico II University

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2021
• Primary Completion (Anticipated): August 1, 2021
• Study Completion (Anticipated): October 1, 2021

Study Registration Dates

• First Submitted: April 22, 2021
• First Submitted That Met QC Criteria: April 26, 2021
• First Posted (Actual): April 27, 2021

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 26, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain
• Other Study ID Numbers: 485/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: none planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No