Evaluation of the Effectiveness of Transcutaneous Electrical Nerve Stimulation During Labor. A Triple Blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Pain (VAS)
研究概览
简要总结
This study evaluates the effectiveness of the Transcutaneus Electric Nerve Stimulation (TENS) during the labour. TENS is a low frequency electrotherapy technique, analgesic type, generally used in musculoskeletal pathology.
The investigators will have three groups of participants to be administered the TENS, a different dose in two groups, while the third will correspond to placebo.
The hypothesis of the study is to verify if the TENS is effective as a non-pharmacological method in the relief of pain during childbirth
详细描述
- Background:
Pain during labour is one of the most intense pain that many women could experience during their lives, and it can be influenced by the anatomical and physiological factors of the labouring women, and also, by their psychological experiences, as well as by cultural, social, and environmental factors.
Neuraxial analgesia during labour is the most effective method for pain relief, but it appears to be associated with certain side effects, such as maternal hypotension, decreased uteroplacental perfusion, foetal bradycardia, fever, pruritus, an increased oxytocin requirement, a prolonged second stage of labour, a higher rate of operative delivery, and high costs.
The use of non-pharmacological methods for pain relief includes a wide variety of techniques aimed at improving physical sensations and preventing psychoemotional perception of pain. Among the main nonpharmacological methods of pain relief at delivery is the application of Transcutaneous electrical nerve stimulation (TENS). Its application during childbirth is based on the Gait Control theory of pain of Melzack and Wall. According to their theory, the application of TENS reduces the excitability of the delta A and C pain fibers, thus reducing the amount of painful messages ascending the spinal cord. Activation of these fibers stimulates the release of natural pain inhibitors.
Furthermore, many non-pharmacological methods of managing pain increase the satisfaction of women with their childbirth experience.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients with a low-risk pregnancy.
- •A gestational age > 37 weeks.
- •A single foetus.
- •Cervical dilation of 4 cm.
- •To be older than 18 years old.
- •Visual deficit that causes difficulty to take the Visual Scale Analogue.
排除标准
- •Refusal to take part in the survey.
- •Failure to Sign Consent Form.
- •Planned Cesarean.
- •High-risk pregnancy.
- •Present skin lesions in the area of the application of the electrodes.
- •Pregnant with physical or mental handicap that prevents the application of the TENS device.
- •Have implanted pacemakers or automatic defibrillators.
研究组 & 干预措施
TENS 1
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.
Dose TENS 1: Biphasic asymmetric pulse, pulse width of 100 µs and a frequency of 100 Hz. The intensity is individually titrated according to the sensitivity of the parturient.
干预措施: TENS 1 (Device)
TENS 1
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.
Dose TENS 1: Biphasic asymmetric pulse, pulse width of 100 µs and a frequency of 100 Hz. The intensity is individually titrated according to the sensitivity of the parturient.
干预措施: TENS 2 (Device)
TENS 2
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.
Dose TENS 2: Biphasic asymmetric pulse, pulse width of 350 µs and a variable frequency between 80 and 100Hz. The intensity is individually titrated according to the sensitivity of the parturient.
干预措施: TENS 2 (Device)
TENS 2
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour.
Dose TENS 2: Biphasic asymmetric pulse, pulse width of 350 µs and a variable frequency between 80 and 100Hz. The intensity is individually titrated according to the sensitivity of the parturient.
干预措施: Placebo TENS (Device)
Placebo TENS
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour. However, TENS has been modified, so that it emits light and sound but does not transmit electrical current.
干预措施: TENS 1 (Device)
Placebo TENS
This group will receive TENS continuously for 30 minutes starting at the beginning of the active phase of labour. However, TENS has been modified, so that it emits light and sound but does not transmit electrical current.
干预措施: Placebo TENS (Device)
结局指标
主要结局
Pain (VAS)
时间窗: - At the beginning of the use of TENS, 10 minutes later and 30 minutes later; for measuring the change of pain.
The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Pregnant Satisfaction
时间窗: Twenty-four hours postpartum, other midwife will ask participants to answer questions regarding their satisfaction with the care provided (COMFORTS scale) and if they would prefer to receive the same type of care in the future.
The investigators will use a scale called Care in Obstetrics : measure for testing satisfaction (COMFORTS). This scale measures satisfaction during delivery and the postnatal period. . This scale is a valid and reliable scale to measure women's satisfaction with the care during labour and postpartum period. The investigators obtained the authorization to use the Spanish version of the COMFORTS scale.
次要结局
未报告次要终点
研究者
Aníbal Báez Suárez
Physiotherapist
University of Las Palmas de Gran Canaria