The Effectiveness of Virtual Reality for Pain Reduction in Women Undergoing Elective Oocyte Cryopreservation: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Post-procedure pain intensity
研究概览
简要总结
This randomized controlled study evaluates whether exposure to relaxing virtual reality (VR) scenery prior to oocyte retrieval can reduce pain in women undergoing elective oocyte cryopreservation.
Many women experience discomfort before and after oocyte retrieval. Virtual reality has been shown to reduce pain in various medical settings by providing distraction and relaxation.
In this study, participants are randomly assigned to receive either routine care alone or routine care combined with a VR-based relaxation intervention while waiting for the procedure.
Pain is assessed using validated questionnaires and standardized scales before and after oocyte retrieval.
The results of this study may help determine whether VR can serve as a simple, safe, and non-pharmacological method to improve patient comfort during elective egg freezing.
详细描述
This study is a prospective, randomized controlled clinical trial evaluating the effectiveness of virtual reality (VR) in reducing pain among women undergoing elective oocyte cryopreservation.
Eligible participants awaiting oocyte retrieval are recruited at the fertility unit. All participants receive detailed information about the study and provide written informed consent prior to enrollment.
Participants are randomized into two parallel groups. The intervention group receives routine care in addition to exposure to relaxing virtual reality nature scenery using a VR headset for approximately 20 minutes prior to oocyte retrieval. The control group receives routine care without exposure to virtual reality.
Baseline assessments include demographic data, medical history, pain sensitivity questionnaire (PSQ), baseline visual analog scale (VAS) pain score, pain threshold assessment, and vital signs.
Following the procedure, pain is reassessed using the visual analog scale. Analgesic administration is documented from medical records. Additional post-procedure assessments include pain-related parameters and vital signs.
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
- None
盲法说明
Due to the nature of the intervention, masking of participants and care providers is not feasible.
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
- •Women undergoing elective oocyte retrieval for fertility preservation.
- •Age 18-45 years.
- •Ability to provide informed consent.
排除标准
- •Use of pain relief, anti-anxiety, or antidepressant medications prior to the intervention.
- •Any condition for which VR use is not recommended, including:
- •History of seizures
- •Sensitivity to flashing light or motion
- •Migraine headaches
- •Predisposition to nausea or dizziness (e.g., vertigo)
- •Any injury to the eyes, face, or neck limiting use of the VR device, including blindness.
结局指标
主要结局
Post-procedure pain intensity
时间窗: Immediately post-procedure in the recovery room (within 1 hour after oocyte retrieval)
Pain intensity measured using a Visual Analog Scale (VAS) ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Pain is assessed in the recovery room following oocyte retrieval.
次要结局
- Baseline pain sensitivity(Before oocyte retrieval)
- Heart rate during oocyte retrieval(Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure)
- Pain intensity prior to discharge(Prior to discharge (same day as oocyte retrieval))
- Change in pain intensity from pre-procedure to post-procedure(From pre-procedure (at admission) to immediately post-procedure in the recovery room)
- Post-procedure analgesic consumption(From completion of oocyte retrieval until discharge from the recovery unit)
- Systolic blood pressure during oocyte retrieval(Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure)
- Diastolic blood pressure during oocyte retrieval(Before, during, and after oocyte retrieval and prior to discharge on the day of the procedure)