Virtual Reality for Pain and Anxiety Relief in Labor

Not Applicable

• Conditions: Labor Pain; Anxiety

• Registration Number: NCT07194967
• Lead Sponsor: University Tunis El Manar

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 Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-03
• Study First Submitted QC: 2025-09-18
• Last Update Submitted: 2025-09-18
• Study First Posted: 2025-09-26
• Last Update Posted: 2025-09-26
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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)
Pulse rate	Immediately before starting the intervention and immediately after completing the intervention	pulse rate mesured in heart beat per minute (bpm)
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
Contraction duration	Immediately before starting the intervention and immediately after completing the intervention	contraction duration measured in minutes
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

Trial Locations

Locations (1)

Ben Arous regional Hospital; 🇹🇳 Ben Arous, Tunisia