Virtual Reality for Pain and Anxiety Relief in Labor

NCT ID: NCT07194967

Last Updated: 2025-09-26

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-09-30

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.

Conditions

Labor Pain; Anxiety

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Group

The patients included in this arm received standard care with no additional intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

VR-group

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

Group Type: EXPERIMENTAL

Virtual Reality Hypnosis for Labor Pain and Anxiety Management

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

HypnoVR

INDUSTRY

Sponsor Role: collaborator

University Tunis El Manar

OTHER

Sponsor Role: lead

Responsible Party

Nesrine Souayeh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ben Arous regional Hospital

Ben Arous, , Tunisia

Countries

Tunisia

References

Mahrer NE, Gold JI. The use of virtual reality for pain control: a review. Curr Pain Headache Rep. 2009 Apr;13(2):100-9. doi: 10.1007/s11916-009-0019-8.

Reference Type: BACKGROUND

PMID: 19272275 (View on PubMed)

Orhan M, Bulez A. The Effect of Virtual Reality Glasses Applied During the Episiotomy On Pain and Satisfaction: A Single Blind Randomized Controlled Study. J Pain Res. 2023 Jun 29;16:2227-2239. doi: 10.2147/JPR.S412883. eCollection 2023.

Reference Type: BACKGROUND

PMID: 37404226 (View on PubMed)

Slater M. Immersion and the illusion of presence in virtual reality. Br J Psychol. 2018 Aug;109(3):431-433. doi: 10.1111/bjop.12305. Epub 2018 May 21.

Reference Type: BACKGROUND

PMID: 29781508 (View on PubMed)

Other Identifiers

02/2025

Identifier Type: -

Identifier Source: org_study_id