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TENS on Pain Intensity in Primary Dysmenorrhea (TENSinPain)

Primary Purpose

Primary Dysmenorrhea

Status
Completed
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
TENS
Sponsored by
Obafemi Awolowo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring Transcutaneous nerve electrical stimulation,, Pain intensity, Primary dysmenorrhea, Female, Undergraduates

Eligibility Criteria

16 Years - 30 Years (Child, Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Obafemi Awolowo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TENS

Control

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 19, 2018
Last Updated
February 23, 2018
Sponsor
Obafemi Awolowo University
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1. Study Identification

Unique Protocol Identification Number
NCT03446859
Brief Title
TENS on Pain Intensity in Primary Dysmenorrhea
Acronym
TENSinPain
Official Title
Effect of Transcutaneous Electrical Nerve Stimulation (TENS) on Amelioration of Pain Associated With Primary Dysmenorrhea in Female Undergraduates of a Nigerian University
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 4, 2017 (Actual)
Primary Completion Date
November 10, 2017 (Actual)
Study Completion Date
February 16, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Obafemi Awolowo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
Transcutaneous nerve electrical stimulation,, Pain intensity, Primary dysmenorrhea, Female, Undergraduates

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Subjects were randomly allocated to two groups, experimental and control
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
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
Intervention Type
Other
Intervention Name(s)
TENS
Other Intervention Name(s)
Experimental
Intervention Description
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).
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
The scale is from 0-5. 0 is no pain 3 is severe pain and 5 is excruciating pain
Time Frame
5 days

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female undergraduates
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adesola O Ojoawo, PhD
Organizational Affiliation
Obafemi Awolowo University, Ile Ife. Nigeria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Obafemi Awolowo University
City
Ile Ife
State/Province
Osun
ZIP/Postal Code
220005
Country
Nigeria

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan
Citations:
PubMed Identifier
15493566
Citation
Akin M, Price W, Rodriguez G Jr, Erasala G, Hurley G, Smith RP. Continuous, low-level, topical heat wrap therapy as compared to acetaminophen for primary dysmenorrhea. J Reprod Med. 2004 Sep;49(9):739-45.
Results Reference
background
PubMed Identifier
7521353
Citation
Adams JM, Taylor AE, Schoenfeld DA, Crowley WF Jr, Hall JE. The midcycle gonadotropin surge in normal women occurs in the face of an unchanging gonadotropin-releasing hormone pulse frequency. J Clin Endocrinol Metab. 1994 Sep;79(3):858-64. doi: 10.1210/jcem.79.3.7521353.
Results Reference
result

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TENS on Pain Intensity in Primary Dysmenorrhea

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