Effect of Virtual Reality Versus Intravenous Dexmedetomidine on Maternal Anxiety, Stress, Hemodynamics, and Neonatal Outcomes During Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Maternal anxiety
研究概览
简要总结
This study aims to compare the efficacy of intravenous dexmedetomidine infusion versus virtual reality (VR) in reducing maternal anxiety, stress, and hemodynamic instability during cesarean section and their effects on neonatal outcome as respiration and heart rate.
详细描述
Cesarean section (CS) is one of the most frequently performed surgical procedures worldwide, with steadily increasing rates across both developed and developing countries.
Dexmedetomidine, a highly selective α₂-adrenergic receptor agonist, has been increasingly utilized in obstetric anesthesia because of its anxiolytic, sedative, and analgesic properties with minimal respiratory depression.
Non-pharmacological interventions, such as virtual reality (VR), have emerged as innovative strategies for perioperative anxiety management. VR provides immersive distraction, thereby modulating pain perception and reducing stress.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age over 18 years old.
- •American Society of Anesthesiologists (ASA) physical status II.
- •Scheduled for elective cesarean section (CS) delivery under Central Neuraxial Blockade.
- •Provide informed consent and agree to participate in the study.
排除标准
- •Patient's refusal
- •Patient known have contraindications for Regional Anesthesia as infection at the site of injection, severe coagulopathy or allergy to local anesthetics.
- •Patient with psychiatric disorders.
- •Sensory impairment (blindness, deafness).
- •Any technical problem preventing proper fitting of the glasses to the patient face.
- •Patients with cognitive impairment, epilepsy or with claustrophobia
- •Patients with suspected eye infection
- •Signs of active labor.
- •Pregnancy related-diseases or antepartum hemorrhage.
- •Presence of Fetal distress.
研究组 & 干预措施
Dexmedetomidine group
Following confirmation of adequate spinal anesthesia, dexmedetomidine will be administered as an intravenous infusion of 0.2-0.4µg/kg/hr until abdominal closure.
干预措施: Dexmedetomidine (Drug)
Virtual reality group
Participants will be fitted with virtual reality headsets immediately after the establishment of spinal anesthesia. The headsets will display calming immersive audiovisual content, and participants will continue wearing them throughout the entire procedure until skin closure.
干预措施: Virtual reality (Other)
结局指标
主要结局
Maternal anxiety
时间窗: Two hours postoperatively in the recovery room
Maternal anxiety will be assessed at three time points (On admission to the operating theatre, At skin suturing, Two hours postoperatively in the recovery room) using the Novel Visual Facial Anxiety Scale (NVFAS), a validated pictorial self-report measure. NVFAS will be applied to measure acute state anxiety. This self-reported pictorial tool consists of 11 facial expressions corresponding to anxiety scores from 0 (no anxiety) to 10 (severe anxiety). The scale is user-friendly, language-independent, and has been validated for perioperative patients, including those with limited time for traditional questionnaires.
次要结局
- Heart rate(24 hours postoperatively)
- Mean arterial pressure(24 hours postoperatively)
- Peripheral Oxygen Saturation(24 hours postoperatively)
- Stress Level(Two hours postoperatively in the recovery room)
- Maternal Satisfaction(Two hours postoperatively in the recovery room)
- Apgar score(5 minutes postoperatively)
研究者
Emad Mohamed Sayed
Resident of Anesthesia and Intensive Care, Benha University, Benha, Egypt.
Benha University