Virtual Reality for Pain and Anxiety Relief in Labor (NCT07194967) | Clinical Trial Compass
By InvitationNot Applicable
Virtual Reality for Pain and Anxiety Relief in Labor
Tunisia70 participantsStarted 2025-05-01
Plain-language 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 women at several hospitals in Tunis. We will also evaluate the satisfaction of women after the exposure to the virtual reality headset.
Who can participate
Age range18 Years – 45 Years
SexFEMALE
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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 abnormali…
What they're measuring
1
pain level
Timeframe: Immediately before starting the intervention and immediately after completing the intervention
2
anxiety level
Timeframe: Immediately before starting the intervention and immediately after completing the intervention