Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Level of pain:visual analog scale
研究概览
简要总结
Pain Relief During Unsedated Office Hysteroscopy by Applying Transcutaneous Electrical Nerve Stimulation : Randomized controlled trial
详细描述
Patients fulfilling inclusion criteria will be distributed in two groups, each one will be (60) patients (more than sample size number) to avoid the drop in the size of the study.
Group (A):(60) Active TENS during office hysteroscopy. Group (B)(60) placebo TENS during office hysteroscopy. The active TENS intervention consisted of a varying high-frequency (80-100 Hz), pulse duration 400-microseconds.Transcutaneous electrical nerve stimulation therapy will be initiated 5 minutes before starting the hysteroscopy and for the duration of the procedure. Two sets of two self-adhesive electrodes (circular pads) will be placed parallel to the spinal cord at the T10-L1 and S2-S4 levels .
Group (A)(60) Active TENs during office hysteroscopy The device intensity (amplitude) will be individually adjusted to each participant's maximum sensory level (strongest reported tingling feeling without pain and with no muscle contractions. Patients will be informed about the importance of maintaining the stimulation at a maximum non painful level. Thus, the TENS output intensity will be increased during the treatment every time the patient accommodated to the TENS stimulus. All the hysteroscopies will be performed by the same experienced consultant in (ECDU), who will be blinded to the patients' group allocations. Uterine cavity will be distended with normal saline
Group (B):(60) placebo TENs during office hysteroscopy To achieve blinding in the placebo group, participants will be connected to the TENS unit in exactly the same way as participants in the active TENS group with the unit emitting the active indicator light and sound but delivering no electrical stimulation.
Primary Outcome Measures :
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenopausal endometrial thickening >4mm.
- •Suspicious endometrial polyp or leiomyoma.
- •Infertility study.
- •Menstrual disorder.
- •Suspicious endometrial carcinoma
排除标准
- •• Genital infection.
- •Undiagnosed genital bleeding.
- •Contraindication to office hysteroscopy.
- •Previous cervical surgery.
- •Neurological deficit.
- •Chronic or preprocedural use of opioids or psychoactive drugs.
- •Previous experience in TENS.
- •Cutaneous damage on the application sites.
- •Pacemakers or automatic implanted cardiac defibrillators.
- •Refusal to sign the informed consent form.
- •Inability to understand informed consent.
结局指标
主要结局
Level of pain:visual analog scale
时间窗: 5 minutes after procedures
Using visual analog scale VAS; 0 mm=no pain and 100 mm=worst possible pain).
Verbal likert scale
时间窗: 5 minutes after procedures
A discrete, 5-point, verbal Likert scale including the following options: "no pain," "minimal pain," "moderate pain," "severe pain," and "worst pain possible," was also used to assess the internal consistency of the pain rating within the study.
次要结局
- The duration of procedures(5 minutes after procedures)
- TENS advers effect(5 minutes after procedures)
- Pain during procedures(5 minutes after procedures)
- vital parameters(5 minutes after procedures)
- Vital parameters(5 minutes after saturation)
- Vasovagal symptoms(5 minutes after procedures)
- Level of satisfaction(5 minutes after procedures)
研究者
Ebtihal Sameih Ali Alnomany
Principle investigator
Ain Shams University