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

NCT06518525 | Completed

• 1 other identifier: B.30.2.AYD.0.00.00
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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).

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Menstruation; Pain; Tele-Exercise; pilates

Outcome Measures

Primary Outcomes (5)

• Sure, here is the English translation: Visual Analog Scale

  The Visual Analog Scale (VAS) was used to assess pain in the study. The VAS is a horizontal or vertical line that is 10 cm in length. At the beginning of the line, the phrase "no pain" is placed, and at the end, "unbearable pain" is written. Participants are asked to mark the point on the line that corresponds to the severity of the pain they experience. The distance between the point where the VAS value is the lowest and the point where the patient marked is measured, and the numerical value corresponding to the pain severity is recorded

  Baseline and 6 weeks later

• Nottingham Health Profile

  The Nottingham Health Profile (NHP) is a quality of life assessment questionnaire developed in 1987 to determine the degree to which individuals' perceived health problems affect their daily activities. The Turkish version of the scale was developed and psychometrically evaluated by Küçükdeveci et al. The NHP consists of six sub-dimensions: pain (8 items), emotional reactions (9 items), sleep (5 items), social isolation (5 items), physical activity (8 items), and energy (3 items). The questionnaire is answered with 'yes' or 'no'. Each section of the questionnaire is calculated separately; the sub-dimension score is obtained by summing the 'yes' responses to the items in each sub-dimension and dividing by the number of items in that sub-dimension, then multiplying by 100. Each sub-dimension scores between 0 and 100, with higher scores indicating lower quality of life

  Baseline and 6 weeks later

• Menstrual Symptom Questionnaire

  he Menstrual Symptom Questionnaire (MSQ) was developed in English by Chesney and Tasto in 1975 to assess pain and other symptoms associated with menstruation. The Turkish validity and reliability were completed by Güvenç et al. in 2014. The scale consists of 24 items in total, in a 5-point Likert-type format. It includes three sub-dimensions: 'Negative Effects/Somatic Complaints' (13 items), 'Pain Symptoms' (6 items), and 'Coping Methods' (3 items). Participants are asked to rate the symptoms they experience during menstruation as 1 (never), 2 (rarely), 3 (sometimes), 4 (often), and 5 (always). The score for each sub-dimension is calculated as the average of the total points of the items in that sub-dimension. The total score of the MSQ is calculated by averaging the total points of all scale items; higher scores indicate greater severity of menstrual symptoms.

  Baseline and 6 weeks later

• Menstrual Attitude Questionnaire

  The Menstrual Attitude Questionnaire (MAQ) was developed by Brooks-Gunn and Ruble in 1980, and its validity and reliability in Turkey were established by Kulakaç et al. in 2008. The Turkish version of the MAQ consists of 33 items and five sub-scales in a Likert-type format. These sub-scales are 'Menstruation as a debilitating event' (12 items), 'Menstruation as a bothersome event' (6 items), 'Menstruation as a natural event' (5 items), 'Anticipation and prediction of menstruation' (5 items), and 'Denial of menstruation effects' (7 items). Participants are asked to select one of the following options for each question: 1. Strongly disagree, 2. Disagree, 3. Neutral, 4. Agree, and 5. Strongly agree. Higher average scores from the items, sub-dimensions, or the entire scale indicate a more positive attitude towards menstruation.

  Baseline and 6 weeks later

• Functional and Emotional Dysmenorrhea Scale

  The Functional and Emotional Dysmenorrhea Scale (FEDS) is used to measure functional and emotional health in dysmenorrhea. It was developed by Li et al. in 2012, and its Turkish validity and reliability were established by Gün in 2014. The FEDS consists of 14 items in total, with two sub-dimensions: functional dysmenorrhea and emotional dysmenorrhea. Participants are asked to choose the option that best describes their condition for each item: 1. Does not resemble my condition at all, 2. Does not quite resemble my condition, 3. Both resembles and does not resemble my condition, 4. Somewhat resembles my condition, 5. Very much resembles my condition. Higher scores indicate greater functional and emotional impact from dysmenorrhea.

  Baseline and 6 weeks later

Study Arms (2)

pilates-based tele-exercises

EXPERIMENTAL

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. .

Other: pilates-based tele-exercises

control group

NO INTERVENTION

control group

Interventions

pilates-based tele-exercises OTHER

pilates-based tele-exercises

pilates-based tele-exercises

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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,

You may not qualify if:

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

Sponsors & Collaborators

• Derya Azim: lead
• Okan University: collaborator

Study Sites (1)

Bandırma Onyedi Eylul University

Balıkesir, Bandırma, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Emine Atıcı

  Okan University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 24, 2024
• Study Start: August 1, 2024
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: February 26, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)