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Effects of Combined Exercises on Primary Dysmenorrhea

Primary Purpose

Primary Dysmenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Exercise
Sponsored by
Eastern Mediterranean University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Dysmenorrhea focused on measuring exercise

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Eastern Mediterranean UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Treatment Group

Control Group

Arm Description

Individuals will perform exercises 3 times a week.

Individuals will not perform exercises

Outcomes

Primary Outcome Measures

pain changes from baseline to 8 weeks
to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.

Secondary Outcome Measures

menstrual symptoms changes from baseline to 8 weeks
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.
sleep quality changes from baseline to 8 weeks
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

Full Information

First Posted
June 4, 2018
Last Updated
September 26, 2018
Sponsor
Eastern Mediterranean University
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1. Study Identification

Unique Protocol Identification Number
NCT03625375
Brief Title
Effects of Combined Exercises on Primary Dysmenorrhea
Official Title
Effects of Combined Exercises on Primary Dysmenorrhea
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 20, 2018 (Actual)
Primary Completion Date
September 2018 (Anticipated)
Study Completion Date
September 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Mediterranean University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Dysmenorrhea
Keywords
exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment Group
Arm Type
Experimental
Arm Description
Individuals will perform exercises 3 times a week.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
Individuals will not perform exercises
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises
Primary Outcome Measure Information:
Title
pain changes from baseline to 8 weeks
Description
to asses pain level with Visual Analogue Scale. 0 means no pain. Higher points means higher pain.
Time Frame
To asses pain level changes in this study assement make at baseline and repeat after 1 and 2 months
Secondary Outcome Measure Information:
Title
menstrual symptoms changes from baseline to 8 weeks
Description
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.
Time Frame
At baseline, after 4 weeks from baseline and 8 weeks after baseline
Title
sleep quality changes from baseline to 8 weeks
Description
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
Time Frame
At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cisel Demiralp
Phone
095338412953
Email
ptciseldemiralp@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berkiye Kırmızıgil
Organizational Affiliation
Eastern Meditteranean University
Official's Role
Study Director
Facility Information:
Facility Name
Eastern Mediterranean University
City
Famagusta
ZIP/Postal Code
99450
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cisel Demiralp, Bsc
First Name & Middle Initial & Last Name & Degree
Cisel Demiralp, Bsc
Phone
05338412953
Email
ciseldemir.cd@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32415471
Citation
Kirmizigil B, Demiralp C. Effectiveness of functional exercises on pain and sleep quality in patients with primary dysmenorrhea: a randomized clinical trial. Arch Gynecol Obstet. 2020 Jul;302(1):153-163. doi: 10.1007/s00404-020-05579-2. Epub 2020 May 15.
Results Reference
derived

Learn more about this trial

Effects of Combined Exercises on Primary Dysmenorrhea

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