Anxiety, Labor Pain
Conditions
Keywords
Virtual Reality, hypnosis, pain management, anxiety, labor, Randomized Controlled Trial
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.
Interventions
DEVICEVirtual 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.
Sponsors
HypnoVR
University Tunis El Manar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Parallel Randomized Controlled Trials
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain level | Immediately before starting the intervention and immediately after completing the intervention | 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). |
| anxiety level | Immediately before starting the intervention and immediately after completing the intervention | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| contractions intensity | Immediately before starting the intervention and immediately after completing the intervention | contractions intensity is measured by NST machine, in millimiter of mercury (mmHg) |
| Contraction frequency | Immediately before starting the intervention and immediately after completing the intervention | Contraction frequency per 10 mn These measurements were made using an NST machine |
| Blood pressure | Immediately before starting the intervention and immediately after completing the intervention, both systolic and diastolic blood pressures are mesures in millimetres of mercury (mmHg) | Blood pressure in millimetres of mercury (mmHg) |
| Patient's satisfaction | After giving birth postpartum within two hours (H2) | 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 |
| Contraction duration | Immediately before starting the intervention and immediately after completing the intervention | contraction duration measured in minutes |
| Pulse rate | Immediately before starting the intervention and immediately after completing the intervention | pulse rate mesured in heart beat per minute (bpm) |
Countries
Tunisia
Outcome results
None listed