NCT07194967

Virtual Reality for Pain and Anxiety Relief in Labor

Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial

• Status: Enrolling By Invitation
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: University Tunis El Manar · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Labor Pain
• Anxiety

Interventions

Type	Name	Description
DEVICE	Virtual Reality Hypnosis for Labor Pain and Anxiety Management	For patients randomized to the intervention arm, the investigator will provide a clear explanation of the procedure and the use of the HypnoVR virtual reality headset. The investigator will remain present throughout the session to supervise the experience, using the companion tablet to monitor the visualization in real time. Participants will be invited to select one of eight immersive visual environments designed to promote relaxation and analgesia during labor. Available options include: Tropical Beach, Underwood, Underwater Dive, Zen Garden, Astral Travel, Winter Landscape, Aurora Borealis, and Oasis. Patients will be informed that they may discontinue the use of the headset at any time and for any reason, without any consequences for their standard medical care.

Timeline

• Start date: 2025-05-01
• Primary completion: 2025-09-30
• Completion: 2025-09-30
• First posted: 2025-09-26
• Last updated: 2025-09-26

Locations

1 site across 1 country: Tunisia