Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT07194967
Brief 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.
Study:
NCT07194967
Study Brief:
Protocol Section:
NCT07194967