Virtual Reality for Pain and Anxiety Relief in Labor

Официальное название

Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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: Trop

Первичные конечные точки

• pain level [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]
• anxiety level [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]

Вторичные конечные точки (6)

• Blood pressure [Срок оценки: 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 [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]
• contractions intensity [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]
• Contraction frequency [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]
• Contraction duration [Срок оценки: Immediately before starting the intervention and immediately after completing the intervention]
• Patient's satisfaction [Срок оценки: After giving birth postpartum within two hours (H2)]

Критерии участия

Критерии включения

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)

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Поддерживающая терапия

Центры проведения

Tunisia · 1 центр

• Ben Arous regional Hospital — Ben Arous

Публикации

• 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. PMID 19272275
• 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. PMID 37404226
• 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. PMID 29781508

Идентификаторы

NCT: NCT07194967 · 02/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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