- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05290181
The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms (PMS)
February 3, 2023 updated by: Ayca Balmumcu, Aydin Adnan Menderes University
The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms: A Randomized Controlled Study
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
68
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Söke
-
Aydin, Söke, Turkey, 9000
- Aydin Adnan Menderes University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Pilates exercise and whatsapp text message group
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.
|
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.
|
NO_INTERVENTION: Control group
No intervention will be made in the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premenstrual syndrome scale (PMSS)
Time Frame: Baseline
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premenstrual syndrome scale (PMSS)
Time Frame: Immediately after the 8-week support intervention program
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 12, 2022
Primary Completion (ACTUAL)
March 2, 2022
Study Completion (ACTUAL)
June 5, 2022
Study Registration Dates
First Submitted
March 3, 2022
First Submitted That Met QC Criteria
March 19, 2022
First Posted (ACTUAL)
March 22, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 6, 2023
Last Update Submitted That Met QC Criteria
February 3, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ABalmumcu
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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