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.

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 of labor will be randomly assigned to either a VR intervention group or a control group receiving standard care.

Primary outcomes include pain level, measured using the Visual Analogue Scale (VAS), and anxiety level, assessed with the State-Trait Anxiety Inventory (STAI-Y). Both will be evaluated before and after the intervention.

Secondary outcomes include maternal vital signs (blood pressure and pulse), labor parameters (contraction frequency, duration, and intensity via NST), fetal parameters (heart rate and decelerations via Doppler), and maternal satisfaction (measured postpartum using a VAS satisfaction scale).

This study aims to determine whether HypnoVR can be an effective non-pharmacological method for improving the labor experience.

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)

Individual Participant Data (IPD) will not be shared due to concerns regarding participant confidentiality and data privacy. Although data will be collected in a de-identified format, the risk of re-identification cannot be completely eliminated, especially in small or vulnerable populations. In addition, no explicit consent for data sharing beyond the scope of the current study has been obtained from participants. Therefore, to comply with ethical standards and data protection regulations (e.g., GDPR), IPD will not most likely be made publicly available.