Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT07194967
Eligibility Criteria:
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for inclusion in the study:
* Female participants aged between 18 and 45 years
* Primiparous or multiparous
* Singleton pregnancy
* Cephalic (vertex) presentation
* Gestational age between 37 and 41 completed weeks
* Admitted in spontaneous (uninduced) labor
* Low-risk pregnancy with no obstetric complications (e.g., no preeclampsia, gestational diabetes, or intrauterine growth restriction)
* Spontaneous and uneventful course of pregnancy
* At least four documented prenatal care visits during pregnancy
* Expressed desire for vaginal delivery
* Provided written informed consent to participate in the study
Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria:
* History of any psychiatric disorder (e.g., anxiety, depression, bipolar disorder, psychosis, delirium) organic brain disease, or cognitive/developmental disorders)
* History of seizures or epilepsy
* Any degree of hearing impairment
* Any visual impairment
* History of face, neck, or head injuries that may interfere with the use of virtual reality equipment
* History of motion sickness or vestibular disorders (e.g., dizziness, vertigo)
* Chronic pain conditions or frequent migraines
* History of claustrophobia
* High-risk pregnancy (e.g., fetal growth restriction, placenta previa, or other significant maternal-fetal complications)
* Known fetal anomalies or placental abnormalities
* Labor pain not attributed to uterine contractions
* Induced labor (medically or pharmacologically initiated)
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT07194967
Study Brief:
Protocol Section:
NCT07194967