Transcutaneous Electrical Nerve Stimulation for Labor Pain Control
Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study
研究概览
详细说明
Midwives and the study investigator will ask parturients, who are admitted to the labor ward at Region Hospital Herning satisfying the inclusion and exclusion criteria, whether they are interested in attending the experimental session.
The study will be conducted as soon as the subject is admitted at the labor ward. The study will only be conducted during early and active labor and not during the birth of the baby.
The subject in this study includes the package of a parturient and her neonate (after birth) as we also obtain data about the neonate. Hereby, two consent forms will be obtained. As this study is a non-invasive study, it is decided to have at least the consent of one parent.
The investigator will fill out a questionnaire about the parturient in cooperation with the subject and midwife, including screening questions related to inclusion and exclusion criteria before the experimental session starts.
The study will last approximately one hour and will be conducted during laboring circumstances. KT (Kenoja Thuvarakan) will carry out the experiment, and she will be present in the delivery room during the whole session.
The study includes several outcomes, including subjective and semi-objective pain measures. The primary outcome is VAS (0-10 cm scale), while secondary outcomes include PPT and satisfaction questionnaire (only at the end of the study). The subjects will be asked before, and immediately after the experimental exposure about the four outcomes (VAS and PPT). The subjects will be exposed to one of the two combinations of TENS stimulation (low and high alternating frequency), which will be compared to sham-TENS.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Herning、丹麦、7400
- Region hospital Gødstrup
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Singleton pregnancy
- Between ages 18-39 years
- Vertex presentation
- Speak, read and understand Danish
- At term (37-42 weeks gestation age)
Exclusion Criteria:
- High-risk pregnancies (including risk factors: eclampsia, pre-eclampsia, diabetes, gestational diabetes, hypertension, and hypotension, intrauterine growth restriction, polyhydramnios, and oligohydramnios).
- Pre-gestational body mass index above 40 kg/m2
- Use of fetal-scalp electrode during the experiment
- Use of pacemakers and other electronic implants
- Severe arrhythmia
- Present musculoskeletal/neurological illnesses
- Chronic pain within last 6 months
- Present medicated mental disorders
- Dermatological disorders
- Use of other long-acting pain relief
- Use of TENS 48 hours before the trial
- Drug addiction defines as the use of cannabis, opioids, or other drugs.
- Smokers
- Lack of ability to cooperate
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:TENS1
TENS with 4/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.
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十
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实验性的:TENS2
TENS with 80/100 Hz in frequency, 200 µs in pulse duration, and intensity individually adjusted.
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十
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假比较器:假TENS
频率为 100 Hz、脉冲持续时间为 200 µs 且强度低于 5 mA 的假体。
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十
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Visual Analog scale (VAS)
大体时间:Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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10-cm pain intensity scale with 0 cm is no pain and 10 cm is unbearable pain.
Decreased cm after baseline measurement indicates pain relief.
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Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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Change in Pain pressure threshold
大体时间:Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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Pain sensitivity measurement also defined as the minimum pressure needed to evoke a pain response measured in kPa.
Increased kPa after baseline measurement indicates pain relief.
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Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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TENS 满意度
大体时间:在最后一次测量 VAS 和 PPT 之后
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满意度等级从 0 到 10 [0 表示“不满意”,10 表示“完全满意”]。
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在最后一次测量 VAS 和 PPT 之后
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经验丰富的疼痛减轻
大体时间:在最后一次测量 VAS 和 PPT 之后
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回答是或否
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在最后一次测量 VAS 和 PPT 之后
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再次对使用 TENS 感兴趣
大体时间:在最后一次测量 VAS 和 PPT 之后
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回答是、否或不知道
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在最后一次测量 VAS 和 PPT 之后
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向其他人推荐 TENS
大体时间:在最后一次测量 VAS 和 PPT 之后
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回答是、否或不知道
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在最后一次测量 VAS 和 PPT 之后
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合作者和调查者
调查人员
- 研究主任:Parisa Gazerani, PhD、Aalborg University
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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