Effects of Combined Exercises on Primary Dysmenorrhea

September 26, 2018 updated by: Eastern Mediterranean University
Dysmenorrhea is one of the most common gynecological problem in adolescents and young women. Symptoms of dysmenorrhea include pelvic / abdominal pain, back pain, headache, nausea, vomiting, diarrhea. These symptoms occur before menstrual bleeding or with bleeding and lasts in 12-74 hours. The objective of this study to investigate the effects of combined exercises on dysmenorrhea symptoms. Exercise protocol aerobic, stretching, kegels, pelvic motions and relaxation exercises.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Women with a positive primary dysmenorrhoea symptom between 18 and 30 years of age living in the Turkish Republic of Northern Cyprus will be included in the study. According to the result of the power analysis, 14 subjet for control and 14subjet intervention group were decided.

The eligibility criteria for this study are:

  • The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
  • To have the regular menstrual cycle (24-35 days),
  • To be sedentary

The exclusion criteria for this study are:

  • Women with secondary dysmenorrhea,
  • The women who gave birth or abortion,
  • People with active sexual experience,
  • Women who use intrauterine devices,
  • Individuals with regular drug use,
  • Serious psychological problems
  • Acute musculoskeletal problems,
  • People with neurological or cardiopulmonary disease

This research will consist of exercise and control groups. An exercise protocol consisting of a combination of various exercises will be applied to the exercise group and no exercises will be done for the control group. women in the exercise group will perform two menstrual cycles, three times a week in the presence of a physiotherapist.

Assessments will be made on the day that the symptoms are seen to be the most severe in order to determine the symptoms of the women in both groups. After baseline assements exercises will start at 3rd day of cycle. Assesments will repeat at second and third menstrual bleedings.

Visual Analogue Scale, Menstrual symptom questionnarie and Pittsburgh Sleep Quality Index will be use.

Study Type

Interventional

Enrollment (Anticipated)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Cyprus
      • Famagusta, Cyprus, 99450
        • Recruiting
        • Eastern Mediterranean University
        • Contact:
          • Cisel Demiralp, Bsc
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • The Visual Analogue Scale value is at least 5 per day when the dysmenorrhea symptoms are the most painful,
  • To have the regular menstrual cycle (24-35 days),
  • Being a sedentary (not participating in any regular exercise program).

Exclusion Criteria:

  • Women with secondary dysmenorrhea,
  • The women who gave birth or abortion,
  • People with active sexual experience,
  • Women who use intrauterine devices,
  • Individuals with regular drug use,
  • Serious psychological problems
  • Acute musculoskeletal problems,
  • People with neurological or cardiopulmonary disease.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Individuals will perform exercises 3 times a week.
Other: Exercise
Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises
No Intervention: Control Group
Individuals will not perform exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain changes from baseline to 8 weeks
Time Frame: To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months
to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.
To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
menstrual symptoms changes from baseline to 8 weeks
Time Frame: At baseline, after 4 weeks from baseline and 8 weeks after baseline
to asses menstrual symptoms with menstrual symptoms questionnarie. we will use total point as a data. points are vary between 0 and 110. Higher points means having worse menstrual symptpms.
At baseline, after 4 weeks from baseline and 8 weeks after baseline
sleep quality changes from baseline to 8 weeks
Time Frame: At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline
to asses sleep quality with pittsburgh sleep quality index. We will use total point as data. lowest grade is 0 and 21 is higher point. 0-5 means good sleep, after 10 point it means worse sleep quality
At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eastern Mediterranean University

Investigators

  • Study Director: Berkiye Kırmızıgil, Eastern Meditteranean University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 20, 2018

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 4, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 26, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Dysmenorrhea

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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