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VR Scenario for Labor Pain Control

NCT05879848 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 106

Last updated 2023-05-30

No results posted yet for this study

Summary

The present study aims to evaluate Virtual Reality analgesic interventions for active labor with biofeedback-based Virtual Reality technologies synchronized to uterine activity. The investigators developed a Virtual Reality system modeled on uterine contractions by connection to a cardiotocographic equipment. The present study, based on a multidisciplinary approach, comprised the following phases: 1)development of hardware and software components; 2) design of the Reality scenario through a qualitative focus group discussion study; 3) clinical trial on a sample of 53 cases and 53 controls during active labor.

Conditions

  • Labor Pain

Interventions

OTHER

VR

virtual reality scenario synchronized with the uterine contractions

Sponsors & Collaborators

  • Federico II University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-30
Completion
2022-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05879848 on ClinicalTrials.gov