Premenstrual SyndromePMSNCT05290181
The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms
A study testing A support program with pilates exercise and whatsapp text message in people with Premenstrual Syndrome and Physical Exercise, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premenstrual Syndrome, Physical Exercise, Women's Health
- What is being tested?
- A support program with pilates exercise and whatsapp text message
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 12 Jan 2022to 5 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- - Having a chronic or physical illness that prevents Pilates.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aydin Adnan Menderes University
Aydin, Söke, 9000
About this study
Official title: 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.
Read the 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.
- Conditions
- Premenstrual Syndrome, Physical Exercise, Women's Health
- Being tested
- A support program with pilates exercise and whatsapp text message
- Keywords
- Premenstrual Syndrome, Pilates exercises, Text message, women's health
- Medical subject headings
- Premenstrual Syndrome, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A support program with pilates exercise and whatsapp text messageOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Pilates exercise and whatsapp text message group | Experimental | 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. Receives: Other: A support program with pilates exercise and whatsapp text message |
| Control group | No intervention | No intervention will be made in the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary outcomes (1)
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.
Measured: Immediately after the 8-week support intervention program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2022
- Study start12 Jan 2022
- Primary completion2 Mar 2022
- Study completion5 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aydin Adnan Menderes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayca Balmumcu, Aydin Adnan Menderes University
- Investigators
- Ayça Balmumcu, PhD, Study director, Aydin Adnan Menderes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05290181
- Sponsor's protocol ID
- ABalmumcu
- Acronym
- PMS
- Status last verified
- Feb 2023
- First submitted
- 3 Mar 2022
- Last updated
- 6 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pilates Exercise and Whatsapp Text-Based Support Program on Premenstrual Syndrome (PMS) Symptoms: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05290181
- Acronym / sponsor ID
- PMS / ABalmumcu
- Conditions
- Premenstrual Syndrome, Physical Exercise, Women's Health
- Keywords
- Premenstrual Syndrome, Pilates exercises, Text message, women's health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Aydin Adnan Menderes UniversityUniversity, hospital or other
- Study start
- 12 Jan 2022 (actual)
- Primary completion
- 2 Mar 2022 (actual)
- Study completion
- 5 Jun 2022 (actual)
- First posted
- 22 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Pilates exercise and whatsapp text message group | Experimental | Other: A support program with pilates exercise and whatsapp text messageA 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. |
| Control group | No intervention | –No intervention will be made in the control group. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- - Having a chronic or physical illness that prevents Pilates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| A support program with pilates exercise and whatsapp text messageFemale 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. | Other | Pilates exercise and whatsapp text message group |
Primary outcome
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.
1 secondary outcome
Premenstrual syndrome scale (PMSS)
Time frame: Immediately after the 8-week support intervention program
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayça Balmumcu, PhD study director
Aydin Adnan Menderes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A support program with pilates exercise and whatsapp text message in people with Premenstrual Syndrome and Physical Exercise, run by Aydin Adnan Menderes University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Premenstrual syndrome scale (PMSS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.