Transcutaneous Electrical Nerve Stimulation as a Pain-relieving Approach in Labor Pain Control: a Randomized Double-blinded Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Visual Analog scale (VAS)
研究概览
简要总结
Transcutaneous electrical nerve stimulation (TENS) is a non-invasive electro-physical modality used for several pain conditions including labor pain control. Despite several years of research, there is still no agreement within the literature regarding the selection of TENS parameters. It is aimed to investigate two types of TENS frequencies (TENS1 alternating between 4 to 100 Hz and TENS2 alternating between 80 to 100 Hz) compared to sham-TENS.
详细描述
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.
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, Investigator)
盲法说明
Double-blinded
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Between ages 18-39 years
- •Vertex presentation
- •Speak, read and understand Danish
- •At term (37-42 weeks gestation age)
排除标准
- •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.
- •Lack of ability to cooperate
结局指标
主要结局
Change in Visual Analog scale (VAS)
时间窗: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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.
Change in Pain pressure threshold
时间窗: Baseline, 10 minutes post stimulation, 30 minutes post stimulation
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.
次要结局
- Recommend TENS to others(Right after last measurements of VAS & PPT)
- Satisfaction of TENS(Right after last measurements of VAS & PPT)
- Experienced pain reduction(Right after last measurements of VAS & PPT)
- Interest in the use of TENS again(Right after last measurements of VAS & PPT)
研究者
Kenoja Thuvarakan
Principle Investigator
Aalborg University