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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06321224
Other study ID # 2024/03/08
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date March 2025

Study information

Verified date March 2024
Source Ankara Yildirim Beyazit University
Contact Seyda Toprak Celenay
Phone +90312 906 1000
Email sydtoprak@hotmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to examine the effects of breathing exercises in women with primary dysmenorrhea.


Description:

Primary dysmenorrhea (PD) is the most common gynecological disorder and constitutes a serious health and economic problem. PD is defined as painful menstrual cramps in the lower abdomen during or a few days before the menstrual period with no detectable organic disease. Breathing exercises are an effective method for pain relief. However, breathing exercises need to be examined in PD management.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 42
Est. completion date March 2025
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria: - Having PD symptoms according to the Primary Dysmenorrhea Consensus criteria, - Having menstrual pain intensity of 4 or higher according to the Visual Analog Scale in the last 6 months, - Having a regular menstrual cycle (28±7 days) - Volunteering to participate in the study. Exclusion Criteria: - Being pregnant or suspected of pregnancy, - Using oral contraceptives or antidepressants in the last 6 months, - Using intrauterine devices, - Having a history of other gynecological diseases - Having pulmonary, neurological and/or systemic disease, - Having undergone abdominal or cardiothoracic surgery within the last year.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Breathing exercises
Breathing exercises will be performed 3 days a week during 2 menstrual periods.
Control
No intervention will be made to the control group and they will be asked to continue their routine lives.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ankara Yildirim Beyazit University

Outcome

Type Measure Description Time frame Safety issue
Primary Menstrual pain intensity Menstrual pain intensity will be evaluated with Visual Analogue Scale. This scale consists of a 10 cm horizontal line. The starting point "0" = "no pain", while "10" = "unbearable pain". After 2 menstrual periods
Secondary Menstrual symptoms Menstrual symptoms will be measured with the Menstrual Symptom Questionnaire, consistng of 24 items.The total score is 120 points. An increase in the mean score indicates an increase in the severity of menstrual symptoms. After 2 menstrual periods
Secondary Life quality Life quality will be evaluated with Dysmenorrhea Impact Scale. The 13-item structure of the scale is scored between 13-65 in total. As the scores obtained from the scale increase, the level of menstruation-related influence in people's lives increases After 2 menstrual periods
Secondary Stress level Stress level will be evaluated with Perceived Stress Scale, consisting of a total of 14 items. The scale is scored between 0-56 in total. A high score from the scale indicates that the person has an increased perception of stress. After 2 menstrual periods
Secondary Sleep quality Sleep quality will be evaluated with Pittsburgh Sleep Quality Index, consisting of 19 items. The total score of the scale ranges from 0 to 21, and a high total score indicates poor sleep quality. After 2 menstrual periods
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