he Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Relief During First Stage of Labor- A single blinded randomized controlled trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Pain index and percentage of pain relief before and after the intervention
研究概览
简要总结
Scientific Title The Efficacy of Transcutaneous Electrical Nerve Stimulation TENS for Pain Relief During the First Stage of Labor A Single Blind Randomised Controlled Trial
Public Title Evaluation of TENS Transcutaneous Electrical Nerve Stimulation for Labour Pain Relief in Women During the First Stage of Labour
Background or Brief Summary Labour pain is one of the most intense physiological experiences for women. Non pharmacological options for pain relief are gaining importance due to their safety and ease of use. Transcutaneous Electrical Nerve Stimulation TENS delivers mild electrical impulses through the skin to modulate pain transmission by stimulating large sensory fibres and promoting natural endorphin release. Previous studies have shown mixed results. This study aims to provide clear evidence on the efficacy and safety of TENS for labour pain relief compared to a sham device.
Study Design Single blind randomised controlled parallel group clinical trial conducted at the Department of Obstetrics and Gynaecology All India Institute of Medical Sciences AIIMS Raipur
Participants Primigravida women aged 18 years and above with singleton cephalic pregnancies at 37 weeks or more in active first stage of labour with cervical dilatation of 4 cm or more
Sample size 70 participants 35 per group calculated for 80 percent power and 5 percent significance level
Intervention Study Group Active portable TENS device applied at T10 to L1 and S2 to S4 dermatomal levels
Control Group Sham inactive TENS device
Both groups will receive standard obstetric care as per WHO labour care guidelines
Primary Outcome 1 Reduction in pain intensity measured using Visual Analogue Scale and Pain Index
2 Requirement of pharmacological analgesia
Secondary Outcomes Duration of first stage of labour
Mode of delivery
Maternal satisfaction score
Neonatal outcomes Apgar score at 1 and 5 minutes need for resuscitation NICU admission
Adverse effects such as rash or burn
Duration Total study duration 24 months including 18 months for recruitment and 6 months for data analysis and report preparation
Expected Outcome The study aims to determine whether TENS is an effective safe and satisfactory non pharmacological method for labour pain relief and to support evidence based obstetric analgesia guidelines
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- Female
入选标准
- •Primigravida Women
- •Singleton pregnancy
- •Gestational Age more than equal to 37 weeks
- •Cephalic Presentation
- •Women in active first stage of labour with (where in active labour is defined as cervical dilatation more than equal to 4cm with adequate uterine contractions).
排除标准
- •Pregnancies with Medical complications such as heart disease, renal disease, psychiatric disease, seizure disorders
- •Antepartum haemorrhage
- •Cephalopelvic disproportion
- •Precipitate labour
- •Previous history of caesarean section or myomectomy
- •Women who received any other method of analgesia before entering to study.
- •Skin lesion at the site of application of TENS patch.
结局指标
主要结局
Pain index and percentage of pain relief before and after the intervention
时间窗: during the first stage of labour (20 hours)
次要结局
- • Duration of first stage of labour(• Mode of delivery)
研究者
Dr Paritosh Gupta
AIIMS Raipur