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临床试验/NCT03446859
NCT03446859已完成不适用

Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Amelioration of Pain Associated With Primary Dysmenorrhea in Female Undergraduates of a Nigerian University

Obafemi Awolowo University2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2017年8月4日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Visual analogue scale

研究概览

简要总结

Dysmenorrhoea is a common problem in women of reproductive age. It is associated with painful uterine contractions and discomfort. The primary aim of the study was to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS) on pain intensity associated with primary dysmenorrhoea among female undergraduate students of Obafemi Awolowo University.

The study involved 50 females undergraduates of Obafemi Awolowo University with primary dysmenorrhoea lasting for at least 5 days. They were allocated in to two groups equally. One group was treated with TENS and other group served as control. The treatment was for 5 days and Pain intensity was measured before and after the treatment in the two groups. The post treatment pain intensity was then compared.

详细描述

Subjects

Participants for this study were female undergraduates of OAU presenting with primary dysmenorrhoea.

Sample size determination

Sample size calculation was performed using the following equation: n = (Z2 P (1-P))/(d2), where n = sample size, Z = Z statistic corresponding to a chosen level of confidence, P = expected prevalence, and d = precision. In the calculation; Z will be= 0.9, P= 0.19 and d= 0.05. This calculation will result in a sample size of 50. TENS will be applied for 25 participants and 25 for control.

Sampling technique

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
None

入排标准

年龄范围
16 Years 至 30 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • Participants with primary dysmenorrhoea, who is single, between the ages of 16 to 30 and have no history of conception, the primary dysmenorrhoea should be at least for five days.

排除标准

  • Individuals presenting with pelvic diseases.
  • Individuals with cardiac problem.
  • Undergraduate with primary dysmenorrhoea but with history of conception.
  • Undergraduate with primary dysmenorrhoea currently using analgesia for pain relief.
  • Undergraduate with primary dysmenorrhoea not up to five days.

研究组 & 干预措施

TENS

Experimental

It consists of 25 subjects with primary dysmenorrhea which were put on TENS for 30 minutes, three for 3 days. The subject were placed in supine lying in a comfortable position as possible. The abdomen to the inguinal region were decently exposed and cleaned, after inspection of the area for cuts, skin infections or any abnormalities. A pair of electrodes ( inactive electrodes) will be placed a little below the umbilicus ( Right and Left) and the other pair(active electrode) along the inguinal region at the level of pubic symphysis ( Right and Left) according to (Akinbo et al 2000). A quadripolar method will be used for electrode placement.

干预措施: TENS (Other)

Control

No Intervention

These are 25 subjects which were not in any intervention. These were subjects that were not placed on TENS and were not used to drug taken for the amelioration of the dysmenorrhea. They were educated on the purpose of research and their inform consent was obtained. Their pain intensity was measured firs, third and 5th days

结局指标

主要结局

Visual analogue scale

时间窗: 5 days

The scale is from 0-5. 0 is no pain 3 is severe pain and 5 is excruciating pain

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Adesola Ojo Ojoawo

Dr (Senior Lecturer

Obafemi Awolowo University

研究点 (2)

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