Virtual Reality (VR)-Based Intervention to Improve Pre-operative Anxiety in Patients Undergoing Elective Oocyte Cryopreservation: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- State and Trait Anxiety (STAI) Score
研究概览
简要总结
A randomized trial assessing the effectiveness of virtual reality exposure prior to an oocyte retrieval procedure in terms of anxiety level .
详细描述
Eligible women, undergoing elective egg freezing, will be offered to participate in the study, and sign a consent form.
The patients will be randomized into 2 groups:
- No intervention (routine management).
- Exposure to scenery video, as a VR (virtual reality) session.
All women will be addressed prior to the procedure, while they are waiting, and upon consent will be asked to state their VAS (visual analogue scale) anxiety score and to fill the STAI (The State-Trait Anxiety Inventory questionnaire.) Vital signs (Heart rate, Blood pressure) will be recorded upon arrival.
Patients who were allocated to the VR arm will watch a 20-minute scenery video and following the session before entering the procedure will be asked to rate their VAS score and answer the STAI questionnaire once again. vital signs will be recorded again.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients before egg retrieval for social reasons (elective egg freezing)
排除标准
- •Use of any medications for pain relief/ anti -anxiety /anti -depressants medication generally or prior to the intervention
- •If suffers from any condition that Use of VR is not recommended:
- •Risk for seizures
- •Sensitivity to flashing light/motion
- •Predisposing to nausea/dizziness (vertigo, etc.) Any injury to the eyes/face/neck that would limit the use of the hardware, including blindness.
研究组 & 干预措施
Routine management
Usual care of patients prior to a surgical procedure : oocyte retrieval
Virtual reality management
20 minutes of scenery VR movies prior to the surgical procedure (oocyte retrieval)
干预措施: The VR instrument - Oculus Quest 2 (Device)
结局指标
主要结局
State and Trait Anxiety (STAI) Score
时间窗: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
The patient's anxiety levels will be assessed using the STAI questionnaire, higher numbers in the questionnaire indicate higher anxiety levels. Levels up to 30 indicate low anxiety, between 30-45 moderate anxiety, more than 46 high anxiety levels.
VAS (visual-analogue scale)
时间窗: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
VAS anxiety score (1-10), Higher levels indicate higher anxiety levels.
Vital signs
时间窗: Up to 8 hours from admission. (Admission, pre-procedural, discharge)
Blood pressure (systolic+ diastolic levels)
次要结局
未报告次要终点
研究者
SUISSA COHEN YAEL
Doctor, MD, Principal investigator
Hadassah Medical Organization