The Effects Of Pilates-Based Tele-Exercise In Primary Dysmenorrhea

NCT ID: NCT06518525

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-01
• Study Completion Date: 2024-11-30

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.

Conditions

Primary Dysmenorrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

pilates-based tele-exercises

Participants in the primary dysmenorrhea study group will be given a general introduction to Pilates-based tele-exercises, and they will be taught five essential elements that they should continuously practice during the exercise process. These elements will be control, breathing, fluidity, precision, and centering. They will be instructed on how to activate the core muscles, including the transverse abdominis, pelvic floor, and multifidus muscles, through isometric contractions while exhaling (centering). The exercises will be conducted over 6 weeks, twice a week, with each session lasting 50 minutes. The exercises, predetermined by the researcher, will be performed under the supervision of a physiotherapist. Each session will be structured into warm-up exercises, main exercises, and cool-down exercises. .

Group Type: EXPERIMENTAL

pilates-based tele-exercises

Intervention Type: OTHER

pilates-based tele-exercises

control group

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

pilates-based tele-exercises

pilates-based tele-exercises

Intervention Type: OTHER

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Okan University

OTHER

Sponsor Role: collaborator

Derya Azim

OTHER

Sponsor Role: lead

Responsible Party

Derya Azim

Assistant Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Emine Atıcı

Role: PRINCIPAL_INVESTIGATOR

Okan University

Locations

Bandırma Onyedi Eylul University

Balıkesir, Bandırma, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

B.30.2.AYD.0.00.00

Identifier Type: -

Identifier Source: org_study_id