Premenstrual AnxietyNCT07037667
New Management of PMS Anxiety
A study testing Pilates exercises and Dietary recommendations in people with Premenstrual Anxiety, run by Cairo University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is : Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary… Read more about this study
- Who is it for?
- Ages 18 to 25 years, women only
- Conditions the study is for
- Premenstrual Anxiety
- What is being tested?
- Pilates exercises and Dietary recommendations
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 May 2024to 4 Feb 2025
- 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 25 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All participants are virgins.
- All of them suffering from moderate and severe premenstrual anxiety.
- Their BMI is less than 30 km/m2
- The regularity of their menstrual cycle is 28-35 days.
Who cannot join
- Smoking.
- Taking any medications for anxiety.
- Irregular menstruation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Pilates Exercises in Management of Premenstrual Anxiety
The goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is :
Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety.
Participants will :
Do Pilates exercises two times per week for 12 weeks.
- Conditions
- Premenstrual Anxiety
- Being tested
- Pilates exercises, Dietary recommendations
- Keywords
- Premenstrual, Anxiety, Pilates exercises
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pilates exercisesOther
Single leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position.
Dietary recommendationsOther
Dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Active comparator | This group will do Pilates exercises as single leg lift 10 rep and one leg circle 5 times in each direction for 15 minutes 2 times per week for 12 weeks and receives dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6. Receives: Other: Pilates exercises; Other: Dietary recommendations |
| Control group | Placebo comparator | This group will receive dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6. Receives: Other: Dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in premenstrual anxiety
State-Trait- Anxiety Inventory for adults (STAI-AD)
Measured: 12 weeks following end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2025
- Study start22 May 2024
- Primary completion26 Dec 2024
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Premenstrual AnxietyStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Summer Kamal Abbas Mabrouk, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07037667
- Sponsor's protocol ID
- P.T.REC/012/004060
- Status last verified
- Oct 2024
- First submitted
- 10 Jun 2025
- Last updated
- 25 Jun 2025
- Results posted
- No
- Data monitoring committee
- 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 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pilates Exercises in Management of Premenstrual Anxiety
- ClinicalTrials.gov ID
- NCT07037667
- Acronym / sponsor ID
- P.T.REC/012/004060
- Conditions
- Premenstrual Anxiety
- Keywords
- Premenstrual, Anxiety, Pilates exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 25 Jun 2025 (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 goal of this clinical trial is to determine the effect of Pilates exercises in management of premenstrual anxiety in adult virgin females.The main question it aims to answer is :
Do Pilates exercises have an effect on premenstrual anxiety? Researcher will compare the effect of Pilates exercises to dietary recommendations as healthy snacks rich in magnesium and vitamin B-6 to see if Pilates exercises have an effect on premenstrual anxiety.
Participants will :
Do Pilates exercises two times per week for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Active comparator | Other: Pilates exercises, Other: Dietary recommendationsThis group will do Pilates exercises as single leg lift 10 rep and one leg circle 5 times in each direction for 15 minutes 2 times per week for 12 weeks and receives dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6. |
| Control group | Placebo comparator | Other: Dietary recommendationsThis group will receive dietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participants are virgins.
- All of them suffering from moderate and severe premenstrual anxiety.
- Their BMI is less than 30 km/m2
- The regularity of their menstrual cycle is 28-35 days.
Key exclusion criteria (3 listed)
- Smoking.
- Taking any medications for anxiety.
- Irregular menstruation.
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 |
|---|---|---|
| Pilates exercisesSingle leg lifts:The participant is in supine lying position with knees bent and feet parallel and hip-width apart. Head, neck and shoulders totally relaxed and arm extended and relaxed beside the body. Then the participant is asked to inhale first without moving her leg then exhale while bringing one leg up towards chest , drawing her pelvic floor and abdominals up and in like gently tightening a belt and maintaining 90 degrees angle at the knee and then put her leg down while inhaling. One leg circle:The participant is in supine lying position with one leg raised towards the ceiling and the other leg on the floor and both knees slightly bent.Then the participant is asked to inhale first without moving her leg and to make sure to use the abdominal muscles to try to maintain a neutral pelvis while doing the exercise then makes a small circle while exhaling and inhale when she completes the circle and reaches the starting position. | Other | Experimental group |
| Dietary recommendationsDietary recommendations as healthy snacks that are rich in magnesium and vitamin B-6. | Other | Control group, Experimental group |
Primary outcome
Change in premenstrual anxiety
Time frame: 12 weeks following end of treatment
State-Trait- Anxiety Inventory for adults (STAI-AD)
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 25 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Premenstrual Anxiety
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pilates exercises and Dietary recommendations in people with Premenstrual Anxiety, run by Cairo University at 1 site in Egypt.
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 4 inclusion and 3 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 25 Jun 2025. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Change in premenstrual anxiety (time frame: 12 weeks following end of treatment). 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 25 Jun 2025.