Labor PainNCT07194967
Virtual Reality for Pain and Anxiety Relief in Labor
A study testing Virtual Reality Hypnosis for Labor Pain and Anxiety Management in people with Labor Pain and Anxiety, run by University Tunis El Manar at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain, Anxiety
- What is being tested?
- Virtual Reality Hypnosis for Labor Pain and Anxiety Management
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTunisia
- Study dates
- 1 May 2025to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 25Show fewer
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial
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.
Read the 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
- Being tested
- Virtual Reality Hypnosis for Labor Pain and Anxiety Management
- Keywords
- Virtual Reality, hypnosis, pain management, anxiety, labor, Randomized Controlled Trial
- Medical subject headings
- Labor Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Hypnosis for Labor Pain and Anxiety ManagementDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | The patients included in this arm received standard care with no additional intervention |
| VR-group | Experimental | 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 Receives: Device: Virtual Reality Hypnosis for Labor Pain and Anxiety Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: Immediately before starting the intervention and immediately after completing the intervention
Secondary outcomes (6)
Blood pressure
Blood pressure in millimetres of mercury (mmHg)
Measured: 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)
Measured: 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)
Measured: 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
Measured: Immediately before starting the intervention and immediately after completing the intervention
Contraction duration
contraction duration measured in minutes
Measured: 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
Measured: After giving birth postpartum within two hours (H2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2025
- Study start1 May 2025
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Labor PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel Randomized Controlled Trials
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Collaborators
- HypnoVR
- Responsible party
- Principal investigator, Nesrine Souayeh, University Tunis El Manar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07194967
- Sponsor's protocol ID
- 02/2025
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2025
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
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.
PubMed 19272275Orhan 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.
PubMed 37404226Slater 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.
PubMed 29781508
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07194967
- Acronym / sponsor ID
- 02/2025
- Conditions
- Labor Pain, Anxiety
- Keywords
- Virtual Reality, hypnosis, pain management, anxiety, labor, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Collaborators
- HypnoVR
- Study start
- 1 May 2025 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 26 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel Randomized Controlled Trials
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –The patients included in this arm received standard care with no additional intervention |
| VR-group | Experimental | Device: Virtual Reality Hypnosis for Labor Pain and Anxiety ManagementPatients 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (25 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality Hypnosis for Labor Pain and Anxiety ManagementFor 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. | Device | VR-group |
Primary outcome
pain level
Time frame: 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
Time frame: 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.
6 secondary outcomes
Blood pressure
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
Time frame: Immediately before starting the intervention and immediately after completing the intervention
contractions intensity
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Contraction frequency
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Contraction duration
Time frame: Immediately before starting the intervention and immediately after completing the intervention
Patient's satisfaction
Time frame: After giving birth postpartum within two hours (H2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2025.
- Results publication: PubMed 19272275Mahrer 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.
- Results publication: PubMed 37404226Orhan 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.
- Results publication: PubMed 29781508Slater 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.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Hypnosis for Labor Pain and Anxiety Management in people with Labor Pain and Anxiety, run by University Tunis El Manar at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 25 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain level (time frame: Immediately before starting the intervention and immediately after completing the intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07194967, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.