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The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms (PMS)

Primary Purpose

Premenstrual Syndrome, Physical Exercise, Women's Health

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
A support program with pilates exercise and whatsapp text message
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premenstrual Syndrome focused on measuring Premenstrual Syndrome, Pilates exercises, Text message, women's health

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Aydin Adnan Menderes University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Pilates exercise and whatsapp text message group

Control group

Arm Description

A support program including pilates exercises and sending text messages will be applied to the students in the intervention group for 8 weeks. Online pilates exercises will be done 2 days a week and individual short messages will be sent to their smartphones via the Whatsapp application 3 days a week. Participants will be provided with Pre Pilates exercises, Pilates Mat Program: Beginner Level, Pilates Mat Program: Intermediate Level, Pilates Mat Program: Advanced level exercises. The exercises will be done online in the presence of a research physiotherapist with The Australian Physiotherapy & Pilates InstituteMatwork Level 1 (APPI) certificate.

No intervention will be made in the control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
March 3, 2022
Last Updated
February 3, 2023
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT05290181
Brief Title
The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms
Acronym
PMS
Official Title
The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 12, 2022 (Actual)
Primary Completion Date
March 2, 2022 (Actual)
Study Completion Date
June 5, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premenstrual Syndrome, Physical Exercise, Women's Health
Keywords
Premenstrual Syndrome, Pilates exercises, Text message, women's health

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
68 female students with PMS who met the inclusion criteria will be divided into groups using a simple random method. There will be 34 female students in the intervention group and 34 female students in the control group.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 exercises and sending text messages will be applied to the students in the intervention group for 8 weeks. Online pilates exercises will be done 2 days a week and individual short messages will be sent to their smartphones via the Whatsapp application 3 days a week.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pilates exercise and whatsapp text message group
Arm Type
Experimental
Arm Description
A support program including pilates exercises and sending text messages will be applied to the students in the intervention group for 8 weeks. Online pilates exercises will be done 2 days a week and individual short messages will be sent to their smartphones via the Whatsapp application 3 days a week. Participants will be provided with Pre Pilates exercises, Pilates Mat Program: Beginner Level, Pilates Mat Program: Intermediate Level, Pilates Mat Program: Advanced level exercises. The exercises will be done online in the presence of a research physiotherapist with The Australian Physiotherapy & Pilates InstituteMatwork Level 1 (APPI) certificate.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention will be made in the control group.
Intervention Type
Other
Intervention Name(s)
A support program with pilates exercise and whatsapp text message
Intervention Description
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.
Primary Outcome Measure Information:
Title
Premenstrual syndrome scale (PMSS)
Description
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.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Premenstrual syndrome scale (PMSS)
Description
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.
Time Frame
Immediately after the 8-week support intervention program

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayça Balmumcu, PhD
Organizational Affiliation
Aydin Adnan Menderes University
Official's Role
Study Director
Facility Information:
Facility Name
Aydin Adnan Menderes University
City
Aydin
State/Province
Söke
ZIP/Postal Code
9000
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms

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