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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Enrollment
70
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.
Ben Arous regional Hospital
Ben Arous, Tunisia
pain level
The investigator assessed the pain level before and after the intervention using a Visual Analogue Scale VAS. The score ranges from 0 (no pain at all) to 10 (the worst pain imaginable).
Time frame: Immediately before starting the intervention and immediately after completing the intervention
anxiety level
The investigator assessed the Anxiety level using the State Trait Anxiety Inventory (STAI) forme Y. The score ranges from 20 to 80 and higher scores are associated with higher levels of anxiety.
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Blood pressure
Blood pressure in millimetres of mercury (mmHg)
Time frame: Immediately before starting the intervention and immediately after completing the intervention, both systolic and diastolic blood pressures are mesures in millimetres of mercury (mmHg)
Pulse rate
pulse rate mesured in heart beat per minute (bpm)
Time frame: Immediately before starting the intervention and immediately after completing the intervention
contractions intensity
contractions intensity is measured by NST machine, in millimiter of mercury (mmHg)
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Contraction frequency
Contraction frequency per 10 mn These measurements were made using an NST machine
Time frame: Immediately before starting the intervention and immediately after completing the intervention
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Contraction duration
contraction duration measured in minutes
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Patient's satisfaction
Satisfaction will be assessed using the Visual Analog Scale for Satisfaction (VAS; 0 = not at all satisfied, 10 = completely satisfied), with higher scores indicating greater satisfaction
Time frame: After giving birth postpartum within two hours (H2)