Virtual Reality for Pain and Anxiety Relief in Labor

University Tunis El Manar

Status: Invitation-only

Conditions: Labor Pain; Anxiety

Treatments: Device: Virtual Reality Hypnosis for Labor Pain and Anxiety Management

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07194967

02/2025

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 70 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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70 participants in 2 patient groups

Control Group

No Intervention group

Description:

The patients included in this arm received standard care with no additional intervention

VR-group

Experimental group

Description:

Patients in the intervention arm received standard obstetric care in addition to a virtual reality hypnosis session using the HypnoVR headset. The VR session, administered during the latent or active phase of labor, included immersive audiovisual content designed to promote relaxation, reduce anxiety, and alleviate pain through guided breathing and hypnotic suggestions

Treatment:

Device: Virtual Reality Hypnosis for Labor Pain and Anxiety Management