TENS on Pain Intensity in Primary Dysmenorrhea
Condition: Primary Dysmenorrhea
MeSH terms: Dysmenorrhea
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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
    

Intervention name(s): TENS
Intervention type(s): Other
Intervention description(s): First, there was explanation of the overall test procedure. The subject was placed in supine lying in a comfortable position.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 (Akinbo et al 2000).
The TENS equipment was switched on and the intensity was set at a level tolerable by each participant's. The treatment period lasted for 30 minutes for each treatment sessions and the procedure was carried out once a day on the 1st, 3rd and 5th days (Akinbo et.al 2000). Pain intensity was measured pre treatment and post treatment each day of treatment using the visual analogue scale (VAS).
Other intervention name(s): Experimental
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects were randomly allocated to two groups, experimental and control
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Transcutaneous nerve electrical stimulation,; Pain intensity; Primary dysmenorrhea; Female; Undergraduates