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Use of Virtual Reality in Active Labor

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Virtual Reality (VR) devices
Sponsored by
Federico II University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Gabriele Saccone

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual Reality (VR) devices

control group

Arm Description

intervention group (VR).

the standard of care (control group, no VR)

Outcomes

Primary Outcome Measures

Subjective pain during the active phase
women pain using visual analogue scale (VAS)

Secondary Outcome Measures

nausea
nausea referred by the patient and episodes of vomiting
anxiety
women axneity using visual analogue scale (VAS)
Incidence of episiotomy
Incidence of episiotomy

Full Information

First Posted
April 22, 2021
Last Updated
April 26, 2021
Sponsor
Federico II University
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1. Study Identification

Unique Protocol Identification Number
NCT04862039
Brief Title
Use of Virtual Reality in Active Labor
Official Title
Use of Virtual Reality in Active Labor
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Anticipated)
Primary Completion Date
August 1, 2021 (Anticipated)
Study Completion Date
October 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual Reality (VR) devices
Arm Type
Experimental
Arm Description
intervention group (VR).
Arm Title
control group
Arm Type
No Intervention
Arm Description
the standard of care (control group, no VR)
Intervention Type
Device
Intervention Name(s)
Virtual Reality (VR) devices
Intervention Description
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.
Primary Outcome Measure Information:
Title
Subjective pain during the active phase
Description
women pain using visual analogue scale (VAS)
Time Frame
"during the active phase of labor up to 10 cm"
Secondary Outcome Measure Information:
Title
nausea
Description
nausea referred by the patient and episodes of vomiting
Time Frame
during the active phase of labor (i.e. after 4-6 cm of dilatation)
Title
anxiety
Description
women axneity using visual analogue scale (VAS)
Time Frame
during the active phase of labor (i.e. after 4-6 cm of dilatation)
Title
Incidence of episiotomy
Description
Incidence of episiotomy
Time Frame
at the time of delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant women
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gabriele Saccone
City
Naples
ZIP/Postal Code
80100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
none planned

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Use of Virtual Reality in Active Labor

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