Effectiveness of Virtual Reality (HypnoVR) in Pain and Anxiety Management During Labor: Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- pain level
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
pain level
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Pulse rate(Immediately before starting the intervention and immediately after completing the intervention)
- contractions intensity(Immediately before starting the intervention and immediately after completing the intervention)
- Contraction frequency(Immediately before starting the intervention and immediately after completing the intervention)
- Contraction duration(Immediately before starting the intervention and immediately after completing the intervention)
- Patient's satisfaction(After giving birth postpartum within two hours (H2))
研究者
Nesrine Souayeh
Associate Professor
University Tunis El Manar