Clinical trial NCT06518525: The Effects Of Pilates-Based Tele-Exercise In Primary Dysmenorrhea
Official title: The Effects Of Pilates-Based Tele-Exercise On Physical And Mental Health In Primary Dysmenorrhea
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Menstruation
Pain
Tele-Exercise
pilates
Lead sponsor: Bandırma Onyedi Eylül University
Sponsor class: OTHER
Collaborators: name: Okan University
First posted: 2024-07-24
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).

Detailed description: In this study, the investigators will aim to investigate the effects of Pilates-based tele-exercise on the physical and mental health of women with primary dysmenorrhea. The study will include 22 volunteers diagnosed with primary dysmenorrhea. Participants will be randomly divided into two groups. The first group will undergo Pilates-based tele-exercises (6 weeks/2 days/50 minutes) (PTTE, n=11). The second group will be a non-intervention control group (CG, n=11). Pain severity will be assessed using the Visual Analog Scale (VAS), and menstrual information will be evaluated using the Menstrual Symptom Questionnaire (MSQ), Menstrual Attitude Questionnaire (MAQ), and Functional and Emotional Dysmenorrhea Scale (FEDS). Quality of life will be assessed using the Nottingham Health Profile (NHP).Inclusion criteria were determined as follows: being between 18-30 years old, diagnosed with primary dysmenorrhea during an ultrasound examination, having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS), being able to attend Pilates sessions twice a week, not engaging in regular exercise, and having a regular menstrual cycle (30-35 days) and bleeding duration (3-10 days). Exclusion criteria included being pregnant, having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders), and not willing to participate in the study. Volunteers who agree to participate in the study will sign an informed consent form, after which they will be given the necessary information about the scales used in the assessment. The scales will be filled out by the participants based on their previous menstrual experiences. After the assessment, Pilates-based tele-rehabilitation exercises will be applied for 6 weeks. At the end of the 6 weeks, assessments will be repeated in both groups. The scales applied to both groups before and after the study will be uploaded to the Google Forms database and sent to the participants.

Eligibility criteria: Inclusion Criteria:

* Being between 18-30 years old,
* Diagnosed with primary dysmenorrhea during an ultrasound examination,
* Having a PD pain score of 4-7 cm on the Visual Analog Scale (VAS),
* Being able to attend Pilates sessions twice a week,
* Not engaging in regular exercise,
* Having a regular menstrual cycle (30-35 days) and a bleeding duration of 3-10 days,

Exclusion Criteria:

* Being pregnant,
* Having serious comorbidities (neurological, cardiovascular, and musculoskeletal disorders),
* Not willing to participate in the study,

Primary outcomes:
measure: Sure, here is the English translation: Visual Analog Scale
timeFrame: Baseline and 6 weeks later
measure: Nottingham Health Profile
timeFrame: Baseline and 6 weeks later
measure: Menstrual Symptom Questionnaire
timeFrame: Baseline and 6 weeks later
measure: Menstrual Attitude Questionnaire
timeFrame: Baseline and 6 weeks later
measure: Functional and Emotional Dysmenorrhea Scale
timeFrame: Baseline and 6 weeks later
Secondary outcomes:
Other outcomes:
Locations:
city: Balıkesir
country: Turkey
facility: Bandırma Onyedi Eylul University
state: Bandırma
Study officials:
affiliation: Okan University
name: Emine Atıcı
role: PRINCIPAL_INVESTIGATOR
References: