Randomized Controlled Trial of Transcutaneous Electrical Nerve Stimulation for Pain Relief During Transvaginal Oocyte Retrieval Using Conscious Sedation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Pain level
研究概览
简要总结
This randomized double-blinded control trial aims to compare the pain levels experienced by the women using the standard conscious sedation and those who had transcutaneous electrical nerve stimulation (TENS) in addition to conscious sedation. The hypothesis is that there will be less pain in women with both conscious sedation and TENS.
详细描述
Women who are indicated to undergo IVF in our center will be assessed for eligibility for the study. Written consent will be obtained from those who agreed to join the study.
Eligible women recruited will be randomized according to a computer-generated randomization list prepared by a designated research staff into one of the two groups on the day of oocyte retrieval
- Patient with both conscious sedation and active TENS
- Patient with conscious sedation and placebo TENS
Blinding Both the women and the physician performing the procedure will be blinded from the group allocation.
Checking of effectiveness of blinding will be done by asking the patient and the physician after the procedure as to which group they think the women is in.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who undergo transvaginal oocyte retrieval
排除标准
- •There is only one ovary
- •Oocyte retrieval performed on one ovary only
- •There are less than three follicles >=16mm in diameter
- •Allergic to pethidine or midazolam
- •Previous experience with TENS
- •Skin damage or allergy at site of TENS pads application
- •History of pacemaker insertion
结局指标
主要结局
Pain level
时间窗: 1 day on the day of the retrieval procedure
The women will be asked to rate the pain according to a 100mm linear visual analogue scale. The visual analogue scale range from 0 to 100, 0 indicating no pain and 100 indicating maximum pain. A small value in the visual analogue scale indicates lower pain levels, therefore better. It is a single level indicated by the patients.
次要结局
- Women satisfaction(1 day on the day of the retrieval procedure)
- Side effects(1 day on the day of the retrieval procedure)