An interventional study of Virtual Reality Hypnosis for Labor Pain and Anxiety Management in Labor Pain and Anxiety, sponsored by University Tunis El Manar. Enrolling by invitation at 1 site in Tunisia. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by University Tunis El Manar · Not applicable, Interventional, and Supportive care
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.
423 studies on the registry are indexed under Labor Pain; 74 are open to participants now.
This study's planned enrollment of 70 is below the median of 100 across 347 interventional studies indexed under Labor Pain.
Browse Labor Pain studies →University Tunis El Manar is the lead sponsor of 74 studies on the registry; 12 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Participants must meet all of the following criteria to be eligible for inclusion in the study:
Exclusion Criteria: Participants will be excluded from the study if they meet any of the following criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The patients included in this arm received standard care with no additional intervention
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
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.
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
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)
Plan to share: Undecided — 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.
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University Tunis El Manar