NCT04862039

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 27, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

3 months

First QC Date

April 22, 2021

Last Update Submit

April 26, 2021

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Subjective pain during the active phase

    women pain using visual analogue scale (VAS)

    "during the active phase of labor up to 10 cm"

Secondary Outcomes (3)

  • nausea

    during the active phase of labor (i.e. after 4-6 cm of dilatation)

  • anxiety

    during the active phase of labor (i.e. after 4-6 cm of dilatation)

  • Incidence of episiotomy

    at the time of delivery

Study Arms (2)

Virtual Reality (VR) devices

EXPERIMENTAL

intervention group (VR).

Device: Virtual Reality (VR) devices

control group

NO INTERVENTION

the standard of care (control group, no VR)

Interventions

Virtual Reality (VR) devicesDEVICE

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.

Virtual Reality (VR) devices

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspregnant women
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton gestations;
  • term pregnancy
  • spontaneous labor
  • diagnosis of active phase of labor;
  • nulliparous between 37 and 42 gestation weeks with cephalic presentation ;

You may not qualify if:

  • 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;
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gabriele Saccone

Naples, 80100, Italy

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Equipment and Supplies

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI MD

Study Record Dates

First Submitted

April 22, 2021

First Posted

April 27, 2021

Study Start

May 1, 2021

Primary Completion

August 1, 2021

Study Completion

October 1, 2021

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

none planned

Locations

IT(1)