Primary Dysmenorrhea Clinical Trial
Official title:
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Amelioration of Pain Associated With Primary Dysmenorrhea in Female Undergraduates of a Nigerian University
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.
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
A purposive sampling was use to select the Obafemi Awolowo University female students among
the undergraduate (participants are volunteers). The consent of the participants were
obtained.
Research design It is a true experimental study.
Instrument - Transcutaneous electrical nerve stimulation (MH6000 Combo, MH6100 EMS, MH6200
TENS) manufactured by Medihightec Medical Co., LTD 30175 Hannover, Germany.
- Electrodes (a squared shaped 40 by 40 MM made in the USA).
- Cotton wool
- Methylated Spirit
- Couch
- A Visual Analogue Scale (VAS) (10 Point numerical scale) to rate pain perception of the
subjects.
Procedure
Ethical approval was obtained from Health and Ethic Research Committee of Institute of Public
Health, Obafemi Awolowo University. Subjects were randomly allocated to two groups. TENS
group of 25 and the control of 25. The subjects in the Experimental group was placed in
supine lying in a comfortable position as possible. The abdomen to the inguinal region was
decently exposed, cleaned using methylated spirit and cotton wool for electrode placement,
after inspection of the area for cuts, skin infections or any abnormalities. The absence of
such skin conditions as well as intact skin sensation indicates suitability for further
procedures. A pair of electrodes ( inactive electrodes) was 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. A quadripolar method was used
for electrode placement.
Before the commencement of the procedure the subjects was educated about Visual Analogue
Scale (VAS).This include how to indicate their pain level. The treatment period lasted for 30
minutes for each treatment sessions and it is once a day for a period of three days that is
for the 1st, 3rd and 5th day . The other group did not receive TENS, they served as control.
Pain intensity was assessed on the first, 3rd and 5th day from the two groups. Dependent t
test was used to compare the mean value of pain intensity within the group on first and 5th
day and independent t test was used to compare the mean value of pain intensity on the first
day and 5th day between Experimental and control group. Alpha level was set at 0.05
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