CompletedNot Applicable

VR Scenario for Labor Pain Control

Italy106 participantsStarted 2021-11-01

Plain-language 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.

Who can participate

Age range18 Years – 45 Years

SexFEMALE

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Inclusion Criteria: * Single term pregnancy; * Full term physiological pregnancy; * Active phase of labor; * Spontaneous labor; * Nulliparous between 37 and 42 weeks of gestation with cephalic presentation; * Maternal age between 18 and 45 years. Exclusion Criteria: * Twin pregnancy; * Preterm labor; * Preterm rupture of amnio membranes; * Fetal abnormalities; * Intrauterine growth restriction; * Post-term pregnancy; * Women with impaired consciousness, seriously ill, mentally disabled; * Women under the age of 18 or over the age of 45; * Women with visual and/or auditory impairments; * Women prone to seizures; * Women with a predisposition to motion sickness; * Refusal to sign informed consent; * Previous cesarean section.

What they're measuring

Subjective pain

Timeframe: 1 year

Trial details

NCT IDNCT05879848

SponsorFederico II University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

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