Menstrual Discomfort, Pain, Primary Dysmenorrhea
Conditions
Keywords
Dysmenorrhea, Menstruation, Visual Analog Scale, Minimal Clinically Important Difference, ROC Curve
Brief summary
The aim of this study is to determine the Minimal Clinically Important Difference (MCID) for the Visual Analog Scale (VAS), Menstrual Symptom Questionnaire (MSQ), and Functional and Emotional Measure of Dysmenorrhea (FEMD) in patients with primary dysmenorrhea (PwPD).
Detailed description
100 PwPD will receive functional exercises three times a week for three menstrual cycles. Patients will be assessed on the most painful days of the first (baseline), second, and third menstrual cycles. The receiver operating characteristics (ROC) method and Gamma coefficient analysis will be applied to determine the responsiveness.
Interventions
OTHERExercise Treatment
In this study, a functional exercise programme will be performed 3 days a week for 8 weeks in three cycles as previously recommended. This programme consisted of a 5-minute warm-up and a 45-minute exercise phase.
Sponsors
Artvin Coruh University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
In this prospective study, one treatment group was formed to receive exercise treatment.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of PD according to the No. 345-Primary Dysmenorrhea Consensus Guideline, * Pain level of three or more according to VAS during activity (moderate to severe pain), * Patients aged 18-35 years (when PD becomes more prevalent), * Regular menstrual cycle with a duration of 28±7 days, * Nulliparity.
Exclusion criteria
* Historical background of chronic urogenital infections or drug use, * Pregnancy, * Secondary dysmenorrhoea caused by gynaecological conditions such as endometriosis, adenomyosis and uterine fibroids.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity | Baseline (On the most painful day of the menstrual cycle before the intervention) | Pain intensity in the lower abdomen, lower back and both thighs will be assessed using a 10 cm Visual Analog Scale (VAS) ranging from 0 (no pain) to 10 (excruciating pain). Pain levels were categorised as 0-2 (safe), 3-5 (acceptable) and 6-10 (risky). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Menstrual Symptom Questionnaire (MSQ) | Baseline (On the most painful day of the menstrual cycle before the intervention) | The Likert scale consists of 22 items, with responses rated on a 5-point range from 1 (never) to 5 (always). The scale includes three components: 'Negative Effects/Somatic Complaints' (items 1-13), 'Menstrual Pain Symptoms' (items 14-19), and 'Coping Methods' (items 20-22). The MSQ score is the mean value of all items in the scale. Increasing scores reflect more menstrual symptoms. |
| Functional and Emotional Measure of Dysmenorrhea (FEMD) | Baseline (On the most painful day of the menstrual cycle before the intervention) | The FEMD is a 14-item measurement tool that evaluates the functional and emotional aspects of dysmenorrhea using a 5-point Likert-type scale. The total scores on this scale range from 14 to 70, with higher scores indicating a more significant functional and emotional impact of dysmenorrhea on an individual. |
| Global Rating Change (GRC) | After the 4-week intervention (On the most painful day of the first menstrual cycle after the start of the intervention) | The GRC comprised seven responses, ranging from 1 to 7, indicating very much better, much better, slightly better, no change, slightly worse, much worse, and very much worse, respectively. |
Countries
Turkey (Türkiye)
Outcome results
None listed