Premenstrual SyndromeExerciseNCT07889141
Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome
A study testing exercises program in people with Premenstrual Syndrome, run by Mansoura University at 2 sites in Egypt.
Trial summary
This study aims to evaluate the effect of an integrated yoga and core stability exercises program on the severity of premenstrual syndrome symptoms and quality of life among nursing students. Read more about this study
- Who is it for?
- Ages 15 to 25 years, women only
- Conditions the study is for
- Premenstrual Syndrome
- What is being tested?
- exercises program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 2 sitesEgypt
- Study dates
- 10 Nov 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 25 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adolescent students Females aged 15- 25 years.
- Have normal body mass index (20 - 29 kg/m2).
- Have PMS symptoms that resolve within 4 days after the onset of menstruation.
- Have at least 6 months of regular cycles (21-35 days and 4-7 days of blood flow).
- Have a smartphone with WhatsApp application.
Who cannot join
- 1. Presence of diabetes, mental and physical illness, or diagnosed psychological disorder.
- 2. History of joint movement and muscle diseases. 3. History of endometriosis, pregnancy. 3. Participating in other exercise programs, being a licensed athlete, or use vitamin-mineral or herbal supplement.
- 4. Adolescent students who consume painkillers or herbal medicines during the intervention or perform other non-pharmacological interventions.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Faculty of Nursing
Al Mansurah, Dakahlia Governorate
Faculty of Nursing
Al Mansurah
About this study
Official title: Effect of an Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome Symptoms and Quality of Life Among Nursing Students
This study aims to evaluate the effect of an integrated yoga and core stability exercises program on the severity of premenstrual syndrome symptoms and quality of life among nursing students.
Read the detailed description
Premenstrual syndrome (PMS) is a common health problem that affects women during the reproductive age. It is a menstrual disorder characterized by a cluster of physical, psychological and behavioral symptoms that manifest cyclically during the luteal phase of the menstrual cycle and resolve rapidly within a few days of the onset of menstruation.
University students are the most vulnerable group to the severe form of PMS due to poor sleep quality, unorganized dietary habits, high caffeine consumption, and chronic academic stress.
Management of PMS usually includes both pharmacological and nonpharmacological modalities. Pharmacological interventions typically serve as the first line of defense for severe presentations. Physical exercise is one of the non-pharmacological interventions for management of PMS that is safe, highly effective and inexpensive. Regular physical activity stimulates the release of beta-endorphins (natural analgesics), reduces circulating cortisol levels, improves systemic blood flow and downregulates inflammatory processes
- Conditions
- Premenstrual Syndrome
- Being tested
- exercises program
- Keywords
- Exercise Program, Premenstrual Syndrome, Quality of Life
- Medical subject headings
- Premenstrual Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercises programBehavioural
practice an integrated yoga and core stability exercises program for 60 minutes, 3 times/week, for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Program | Experimental | practicing an integrated yoga and core stability exercises program for 60 minutes, 3 times/week, for 8 weeks. Receives: Behavioral: exercises program |
| Control | No intervention | practice only the routine daily activities for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tool I: A Structured Interview Questionnaire
This tool will be developed by the researcher after reviewing the literature review (Cassioli et al.,2023; Mohamed, Habib, Gamal, \& Abu Setta, 2024; Şener, \& Özkan, 2026). It will consist of two parts:
Part I: General characteristics of nursing students such as: (age, weight, height, educational class, residence and practicing exercise before the program.…etc).
Part II: Menstrual history of nursing students: It will be used to assess the basic characteristics of menstrual cycle for each student such as: menarche age, frequency of menstrual cycle, duration of menstrual flow, amount of menstrual blood loss, number of pads per day, first experience of PMS, frequency of PMS, onset of pain at each period, total duration of pain in hours, and measures taken during each cycle to get relief from pain…etc).
Measured: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
Tool (II): Premenstrual Symptoms Screening Tool (PSST)
It will be adopted from Steiner, Macdougall, \& Brown. (2003). This tool is a 19-item questionnaire that uses the categorical Standardized Diagnostic (DSM) criteria associated with premenstrual symptoms (PMS) as a symptom rating scale, with degrees of severity. It is divided into two domains. The first domain includes 14 premenstrual symptoms such as; depression, anxiety, irritability, mood swings, decreased interest in activities, difficulties concentrating, exhaustion, eating changes, sleep disruptions, feeling overwhelmed, and physical symptoms. The PSST is interpreted using standardized diagnostic criteria rather than a total score. Each PSST item is rated on a four-point Likert-like scale (i.e., 0 'not at all', 1 'mild', 2 'moderate', and 3 'severe'). For the assessment of moderate to severe P
Measured: At baseline, 4 weeks after the intervention, and 8 weeks after the intervention.
Tool (III): Visual Analogue Scale (VAS)
It will be adopted from Crichton (2001) to assess the intensity of the student's pain. Scores are based on self-reported pain measurements that are recorded with a single hand-written mark placed at one point along a 10-cm line that represents a continuum between the two ends of the scale, they will be instructed to indicate their preference by pointing to the corresponding number on the line or by observing the expression of pain on their face, with "no pain" on the left end (0 cm) and the "worst pain" on the right end (10 cm).The Visual Analogue Scale is divided into three main sections; the first section graded from 1-3 cm, which represents mild pain; the second section rated from 4-7 cm, which represents moderate pain; and the third section graded from 8-10 cm, which repres
Measured: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
Tool (IV): Short Form-36 Health Survey (SF-36):
The researchers will adopt this scale, which was initially created by Ware \& Sherbourne.(1992). The 36-Item Short Form Health Survey (SF-36), a standardized, self-administered generic questionnaire designed to assess perceived physical and mental health. This tool is consisted of 36 items that cover eight health domains including: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and mental health (5 items). The SF-36 will be scored according to the standard scoring manual. Each item will be coded, recoded when necessary, and transformed into a 0-100 scale. Scores will be calculated separately for the eight health domains: For each domain, item scores will be averaged after transformation, yielding a score ranging from 0 to 100. Higher scores indicate better health-related quality of life,
Measured: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2026
- Study start10 Nov 2026 (estimated)
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- Each student will receive one training session in the maternity lab of the faculty, to provide information about the exercise as definition and advantages of the exercise and how to perform the core stability and yoga exercises.
- Masking
- None (open label)
- Enrolment
- 92 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hassan Ragab Elshrqawy, Mansoura University
- Investigators
- Elshrqawy H Eman, lecturer, Principal investigator, Lecturer of woman's Health and Midwifery Nursing, faculty of nursing, Mansoura University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07889141
- Sponsor's protocol ID
- R.26.07.21
- Acronym
- Exercise
- Status last verified
- Oct 2026
- First submitted
- 15 Oct 2026
- Last updated
- 30 Oct 2026
- 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of an Integrated Core Stability Exercises and Yoga Program on Premenstrual Syndrome Symptoms and Quality of Life Among Nursing Students
- ClinicalTrials.gov ID
- NCT07889141
- Acronym / sponsor ID
- Exercise / R.26.07.21
- Conditions
- Premenstrual Syndrome
- Keywords
- Exercise Program, Premenstrual Syndrome, Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 92 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 10 Nov 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 22 Oct 2026 (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.
This study aims to evaluate the effect of an integrated yoga and core stability exercises program on the severity of premenstrual syndrome symptoms and quality of life among nursing students.
Detailed description
Premenstrual syndrome (PMS) is a common health problem that affects women during the reproductive age. It is a menstrual disorder characterized by a cluster of physical, psychological and behavioral symptoms that manifest cyclically during the luteal phase of the menstrual cycle and resolve rapidly within a few days of the onset of menstruation.
University students are the most vulnerable group to the severe form of PMS due to poor sleep quality, unorganized dietary habits, high caffeine consumption, and chronic academic stress.
Management of PMS usually includes both pharmacological and nonpharmacological modalities. Pharmacological interventions typically serve as the first line of defense for severe presentations. Physical exercise is one of the non-pharmacological interventions for management of PMS that is safe, highly effective and inexpensive. Regular physical activity stimulates the release of beta-endorphins (natural analgesics), reduces circulating cortisol levels, improves systemic blood flow and downregulates inflammatory processes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Each student will receive one training session in the maternity lab of the faculty, to provide information about the exercise as definition and advantages of the exercise and how to perform the core stability and yoga exercises.
| Arm | Type | Receives |
|---|---|---|
| Exercise Program | Experimental | Behavioral: exercises programpracticing an integrated yoga and core stability exercises program for 60 minutes, 3 times/week, for 8 weeks. |
| Control | No intervention | –practice only the routine daily activities for 8 weeks |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Adolescent students Females aged 15- 25 years.
- Have normal body mass index (20 - 29 kg/m2).
- Have PMS symptoms that resolve within 4 days after the onset of menstruation.
- Have at least 6 months of regular cycles (21-35 days and 4-7 days of blood flow).
- Have a smartphone with WhatsApp application.
Key exclusion criteria (3 listed)
- 1. Presence of diabetes, mental and physical illness, or diagnosed psychological disorder.
- 2. History of joint movement and muscle diseases. 3. History of endometriosis, pregnancy. 3. Participating in other exercise programs, being a licensed athlete, or use vitamin-mineral or herbal supplement.
- 4. Adolescent students who consume painkillers or herbal medicines during the intervention or perform other non-pharmacological interventions.
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 |
|---|---|---|
| exercises programpractice an integrated yoga and core stability exercises program for 60 minutes, 3 times/week, for 8 weeks. | Behavioural | Exercise Program |
Primary outcome
Tool I: A Structured Interview Questionnaire
Time frame: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
This tool will be developed by the researcher after reviewing the literature review (Cassioli et al.,2023; Mohamed, Habib, Gamal, \& Abu Setta, 2024; Şener, \& Özkan, 2026). It will consist of two parts: Part I: General characteristics of nursing students such as: (age, weight, height, educational class, residence and practicing exercise before the program.…etc). Part II: Menstrual history of nursing students: It will be used to assess the basic characteristics of menstrual cycle for each student such as: menarche age, frequency of menstrual cycle, duration of menstrual flow, amount of menstrual blood loss, number of pads per day, first experience of PMS, frequency of PMS, onset of pain at each period, total duration of pain in hours, and measures taken during each cycle to get relief from pain…etc).
Tool (II): Premenstrual Symptoms Screening Tool (PSST)
Time frame: At baseline, 4 weeks after the intervention, and 8 weeks after the intervention.
It will be adopted from Steiner, Macdougall, \& Brown. (2003). This tool is a 19-item questionnaire that uses the categorical Standardized Diagnostic (DSM) criteria associated with premenstrual symptoms (PMS) as a symptom rating scale, with degrees of severity. It is divided into two domains. The first domain includes 14 premenstrual symptoms such as; depression, anxiety, irritability, mood swings, decreased interest in activities, difficulties concentrating, exhaustion, eating changes, sleep disruptions, feeling overwhelmed, and physical symptoms. The PSST is interpreted using standardized diagnostic criteria rather than a total score. Each PSST item is rated on a four-point Likert-like scale (i.e., 0 'not at all', 1 'mild', 2 'moderate', and 3 'severe'). For the assessment of moderate to severe P
Tool (III): Visual Analogue Scale (VAS)
Time frame: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
It will be adopted from Crichton (2001) to assess the intensity of the student's pain. Scores are based on self-reported pain measurements that are recorded with a single hand-written mark placed at one point along a 10-cm line that represents a continuum between the two ends of the scale, they will be instructed to indicate their preference by pointing to the corresponding number on the line or by observing the expression of pain on their face, with "no pain" on the left end (0 cm) and the "worst pain" on the right end (10 cm).The Visual Analogue Scale is divided into three main sections; the first section graded from 1-3 cm, which represents mild pain; the second section rated from 4-7 cm, which represents moderate pain; and the third section graded from 8-10 cm, which repres
Tool (IV): Short Form-36 Health Survey (SF-36):
Time frame: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.
The researchers will adopt this scale, which was initially created by Ware \& Sherbourne.(1992). The 36-Item Short Form Health Survey (SF-36), a standardized, self-administered generic questionnaire designed to assess perceived physical and mental health. This tool is consisted of 36 items that cover eight health domains including: physical functioning (10 items), role limitations due to physical health (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and mental health (5 items). The SF-36 will be scored according to the standard scoring manual. Each item will be coded, recoded when necessary, and transformed into a 0-100 scale. Scores will be calculated separately for the eight health domains: For each domain, item scores will be averaged after transformation, yielding a score ranging from 0 to 100. Higher scores indicate better health-related quality of life,
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
- 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.
Elshrqawy H Eman, lecturer principal investigator
Lecturer of woman's Health and Midwifery Nursing, faculty of nursing, Mansoura University, Egypt
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercises program in people with Premenstrual Syndrome, run by Mansoura University at 2 sites 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 5 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: opening soon, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elshrqawy H Eman, Lecturer (01554546002, eman_hassan@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tool I: A Structured Interview Questionnaire (time frame: At baseline and during the week preceding menstruation at the first and second menstrual cycles following the intervention, corresponding to the 4-week post-intervention assessment and the 8-week follow-up assessment, respectively.). The study lists 4 primary outcomes in all. 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 30 Oct 2026.