Effects of Combined Exercises on Primary Dysmenorrhea

Primary Dysmenorrhea Clinical Trial

Official title:

Effects of Combined Exercises on Primary Dysmenorrhea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03625375
• Other study ID #: Dysmenorrhea
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2018
• Est. completion date: September 2018

Study information

• Verified date: September 2018
• Source: Eastern Mediterranean University
• Contact: Cisel Demiralp
• Phone: 095338412953
• Email: ptciseldemiralp[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dysmenorrhea
• Primary Dysmenorrhea

Intervention

Other:
• Exercise
Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises

Locations

Country	Name	City	State
Cyprus	Eastern Mediterranean University	Famagusta

Sponsors (1)

Lead Sponsor	Collaborator
Eastern Mediterranean University

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain changes from baseline to 8 weeks	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	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.	At baseline, after 4 weeks from baseline and 8 weeks after baseline
Secondary	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	At baseline of the study, after 4 weeks from baseline and 8 weeks after baseline