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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05290181
Other study ID # ABalmumcu
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 12, 2022
Est. completion date June 5, 2022

Study information

Verified date February 2023
Source Aydin Adnan Menderes University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the effect of Pilates exercise and Whatsapp text message-based support program on PMS symptoms experienced by university female students.


Description:

In this study, it will be answered whether the Pilates exercise and the support program based on Whatsapp text messages have an effect on the PMS symptoms experienced by university female students. Demographic information of the participants will be collected with the Personal Information form. The personal information form is a form prepared by the researchers with the support of the literature, consisting of 21 questions aiming to obtain information about the socio-demographic characteristics, menstrual characteristics, and lifestyle behaviors of the students. PMS symptoms will be evaluated with the Premenstrual Syndrome Scale. First of all, the premenstrual syndrome scale will be applied by trying to reach all 380 female students studying at the school. Afterward, 68 students with PMS who meet the inclusion criteria will be divided into 34 intervention and 34 control groups by simple randomization. In order to prevent interaction between the intervention and control group students in the randomization, the places where the students stay (home, dormitory rooms) will be taken into account. A support program including pilates exercise and WhatsApp text messages will be applied to the initiative group for 8 weeks. No attempt will be made on the control group.


Recruitment information / eligibility

Status Completed
Enrollment 68
Est. completion date June 5, 2022
Est. primary completion date March 2, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria: - Having regular menstrual cycles (intervals of 21-35 days, lasting 3-10 days), - Body mass index of 18.5-24.9 kg/m. to be between - Absence of chronic disease, - Absence of a hormonal disease such as polycystic ovary syndrome, - Using smart mobile phone - Not using oral contraceptives or antidepressants. Exclusion Criteria: - - Having a chronic or physical illness that prevents Pilates.

Study Design


Intervention

Other:
A support program with pilates exercise and whatsapp text message
Female students in the intervention group will be given online pilates exercises 2 days a week for 8 weeks. Pre Pilates exercises, Pilates Mat Program: Beginner Level, Pilates Mat Program: Intermediate Level, Pilates Mat Program: Advanced level exercises will be provided. The exercises will be performed in the company of a research physiotherapist who has The Australian Physiotherapy & Pilates InstituteMatwork Level 1 (APPI) certificate. 3 days a week, individual short messages will be sent to the smartphones of female students via the Whatsapp application. General information about PMS will be sent in the first week, and motivational messages about lifestyle will be sent in the following weeks. Short message contents will be prepared by researchers in line with the literature and expert opinion will be taken. When the support program ends, PMSS will be applied to female students in the intervention group.

Locations

Country Name City State
Turkey Aydin Adnan Menderes University Aydin Söke

Sponsors (1)

Lead Sponsor Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Premenstrual syndrome scale (PMSS) The premenstrual syndrome scale (PMSS) aims to measure the severity of symptoms. The scale consists of 44 items in 5-point Likert type. The Cronbach's alpha value of the scale was determined as 0.75. As stated in the PMSS directive, while filling out the scale, the participants should mark according to the symptoms they felt one week before the period. In scoring the scale, the "Never" option is 1 point, the "Very little" option is 2 points, the "Sometimes" option is 3 points, the "Frequently" option is 4 points, and the "Constantly" option is evaluated. as 5 points. While evaluating the PMSS results, the presence of PMS is evaluated according to the condition of passing 50% of the highest score that can be obtained from the total and subscale scores. The highest possible score for the total score is 220, 50% of which is 110. A score above 110 points on the scale indicates the presence of PMS. Baseline
Secondary Premenstrual syndrome scale (PMSS) The premenstrual syndrome scale (PMSS) aims to measure the severity of symptoms. The scale consists of 44 items in 5-point Likert type. The Cronbach's alpha value of the scale was determined as 0.75. As stated in the PMSS directive, while filling out the scale, the participants should mark according to the symptoms they felt one week before the period. In scoring the scale, the "Never" option is 1 point, the "Very little" option is 2 points, the "Sometimes" option is 3 points, the "Frequently" option is 4 points, and the "Constantly" option is evaluated. as 5 points. While evaluating the PMSS results, the presence of PMS is evaluated according to the condition of passing 50% of the highest score that can be obtained from the total and subscale scores. The highest possible score for the total score is 220, 50% of which is 110. A score above 110 points on the scale indicates the presence of PMS. Immediately after the 8-week support intervention program
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