VR Scenario for Labor Pain Control (NCT05879848) | Clinical Trial Compass
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 range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.