Status:
ENROLLING_BY_INVITATION
Virtual Reality for Pain and Anxiety Relief in Labor
Lead Sponsor:
University Tunis El Manar
Collaborating Sponsors:
HypnoVR
Conditions:
Labor Pain
Anxiety
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
The aim of this study is to evaluate the impact of virtual reality hypnosis technique on pain and anxiety of women during labor. We will perform a randomized controlled trial on a group of labouring w...
Detailed Description
This multicenter randomized controlled trial evaluates the effectiveness of a virtual reality hypnosis device (HypnoVR) in managing pain and anxiety during labor. Women in the latent and active phases...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
May 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2025
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT07194967
Start Date
May 1 2025
End Date
September 30 2025
Last Update
September 26 2025
Active Locations (1)
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1
Ben Arous regional Hospital
Ben Arous, Tunisia, 2096