AzTrials
AzTrials

Premenstrual SyndromeNCT07642232

Effects of Somatic Movement Therapy vs Core Strengthening in Premenstrual Syndrome

A study testing Group A (Somatic Movement Therapy) and Group B (Core Strengthening Exercise) in people with Premenstrual Syndrome, run by Riphah International University at 1 site in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

Premenstrual Syndrome (PMS) is a multifactorial disorder affecting women of reproductive age, causing physical discomfort, emotional instability, and reduced quality of life. This randomized clinical trial aims to compare the effects of Somatic Movement Therapy (SMT) and Core Strengthening Exercises (CSE) on symptom… Read more about this study

Who is it for?
Ages 18 to 35 years, women onlyHealthy volunteers can take part
Conditions the study is for
Premenstrual Syndrome
What is being tested?
Group A (Somatic Movement Therapy) and Group B (Core Strengthening Exercise)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 sitePakistan
Study dates
5 May 2025to 15 Aug 2026
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 18 to 35 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Females aged 18 to 35 years.
  • Married and single women
  • Regular menstrual cycles (21-35 days) for the past 6 months.
  • Diagnosed with Premenstrual Syndrome (PMS) based on ACOG (American College of Obstetricians and Gynecologists) criteria

Who cannot join

  • Diagnosed with PMDD or major psychiatric disorders (e.g., anxiety, depression).
  • Using hormonal contraceptives or mood/menstruation-altering medications
  • History of gynecological conditions (e.g., PCOS, endometriosis, fibroids).
  • Presence of chronic illnesses (e.g., diabetes, hypertension, CVD, thyroid disorders)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Imran Amjad, PHD* contact

03324390125

imran.amjad@riphah.edu.pk

Imran Amjad, PHD* contact

0515481826

imran.amjad@riphah.edu.pk

Pakistan1 site, 1 recruiting
  • Ghurki Trust Hoapital

    Lahore, Punjab Province, 54000

    Ghulam Fatima, PhD*, 03034073057, ghulam.fatima@riphah.edu.pk

    Recruiting

Other trials in Pakistan

About this study

Official title: Effects of Somatic Movement Therapy Versus Core Strengthening Exercises on Symptom Severity, Perceived Stress, and Quality of Life in Premenstrual Syndrome

Premenstrual Syndrome (PMS) is a multifactorial disorder affecting women of reproductive age, causing physical discomfort, emotional instability, and reduced quality of life. This randomized clinical trial aims to compare the effects of Somatic Movement Therapy (SMT) and Core Strengthening Exercises (CSE) on symptom severity, perceived stress, and quality of life in 34 female participants aged 18-35 years diagnosed with PMS according to ACOG criteria. Group A will receive SMT, while Group B will perform CSE over a 6-week program. Outcomes will be measured using PSST, PSS-10, and WHOQOL-BREF, with data analyzed through SPSS version 27.

Read the detailed description

Premenstrual Syndrome (PMS) is a complex and multifactorial disorder affecting a significant proportion of women of reproductive age, often resulting in substantial physical discomfort, emotional instability, and reduced quality of life. Recent studies have confirmed the use of movement-based therapeutic interventions as effective prescription-free methods to provide relief of the symptoms associated with PMS. The purpose of the study is to examine and compare the effect of intervention (Somatic Movement Therapy (SMT) and Core Strengthening Exercises (CSE) on symptom severity, perceived stress, and quality of life in patients with PMS.

This randomized clinical trial will be conducted at Ghurki Trust and Teaching Hospital, involving a sample of 34 female participants aged 18 to 35 years with regular menstrual cycles and a clinical diagnosis of Premenstrual Syndrome according to ACOG (American College of Obstetricians and Gynecologists) criteria. A non-probability convenience sampling method will be used to recruit the participants, and they will be assigned randomly to two intervention groups.

Somatic Movement Therapy will be applied in Group A and will include breath awareness, proprioceptive training, somatic movement, and mindfulness-based relaxation. Group B will be subjected to a highly structured Core Strengthening Exercises regime that involves progressive movement on basic activation to endurance-based core exercises in a 6-week regime (3 sessions/week, 45 minutes/session). Outcome measures include the Premenstrual Symptoms Screening Tool (PSST) for symptom severity, the Perceived Stress Scale (PSS-10), and the WHOQOL-BREF for quality of life. Evaluations will be done at baseline, post-intervention, and follow up. SPSS version 27 will be used to analyze data.

Being tested
Group A (Somatic Movement Therapy), Group B (Core Strengthening Exercise)
Keywords
Core Strengthening Exercises, Perceived Stress, Quality of Life, Somatic Movement Therapy
Medical subject headings
Premenstrual Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Group A (Somatic Movement Therapy)Other

    Participants allocated to Group A will receive a structured Somatic Movement Therapy (SMT) program specifically designed to manage the physiological and psychological manifestations of premenstrual syndrome (PMS). Each session will begin with a centering and breath awareness phase lasting 5 to 10 minutes, wherein diaphragmatic breathing is emphasized to stimulate the parasympathetic nervous system and reduce sympathetic overdrive commonly observed in PMS. It is followed by 15 to 20 minutes of gentle somatic movements. The session then transitions to a body scan and proprioception segment (5-10 minutes), which includes guided internal sensing of different body parts and their spatial orientation, supported by verbal cues or tactile prompts. The session ends by mindfulness and relaxation period (10-15 minutes) adding guided visualization, body integration or meditative stillness.

  • Group B (Core Strengthening Exercise)Other

    Participants in Group B will engage in a progressive Core Strengthening. The sessions will begin with a 5-10-minute warm-up period, which will include low-intensity aerobic activities, dynamic stretching, and simple joint mobilization exercises. The main activation step will take around 25-30 minutes and consist of guided exercises like abdominal bracing exercises, bridges, planks, and bird-dog variations. The progression will be systematic and start with simple exercises of control bases in week 1-2, then add a challenge by adding movements such as side planks, heel slides, and leg raises in week 3-6. As the participants adapt to he regimen, endurance-oriented movements such as bicycle crunches and superman holds will be incorporated during weeks 4-5 to enhance core stability under fatigue. Every session will be concluded by a recovery time (5-10 minutes). It will consist of four 45-minute sessions per week, 3 times per week, and 6 weeks, totaling 18 sessions per subject.

Study groups in NCT07642232
Study groupRoleWhat they receive
Group A: Somatic Movement Therapy (SMT)Active comparatorParticipants in this group will receive somatic movement therapy sessions, including centering and breath awareness, gentle somatic movements (such as pelvic tilts and shoulder rolls), guided body scanning with proprioceptive cues, and mindfulness-based relaxation techniques. The focus will be on body awareness, stress reduction, and mindful movement integration.
Receives: Other: Group A (Somatic Movement Therapy)
Group B: Core Strengthening ExercisesExperimentalParticipants in this group will perform structured core strengthening exercises targeting abdominal, pelvic, and lower back muscles. The sessions will include warm-up routines, progressive core activation exercises (e.g., planks, bridges, bird-dog), and cool-down stretches aimed at improving physical stability, reducing musculoskeletal discomfort, and enhancing overall physical function
Receives: Other: Group B (Core Strengthening Exercise)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Perceived Stress Scale (PSS-10)

    PSS-10 is a psychological tool, which is a well-established measure of past-month perceptions of stress. It measures the degree to which respondents find their lives to be unpredictable, uncontrollable and overwhelming, and thus is very applicable in assessing the level of stress involved in PMS. It is a 10 item survey that is measured on a 5 point Likert scale and is sensitive to pre and post-intervention changes in stress levels after physical and psychological interventions. The PSS-10 will be useful in this study to assess how the interventions have affected stress perceptions among the participants. Psychometric properties are high, with the Cronbach alpha of 0.78-0.91, which demonstrates a good internal consistency and construct validity of the tool .

    Measured: 6 weeks

  2. Premenstrual Symptoms Screening Tool (PSST)

    The PSST is a widely used clinical tool designed to identify and assess the severity of symptoms associated with Premenstrual Syndrome (PMS). It encompasses various physical, emotional, and behavioral symptoms that are normally experienced in the luteal stage of the menstrual cycle. Participants evaluate the severity and effects of irritability, bloating, fatigue, mood swings, and sleeping disturbances. Regarding this study, the PSST will be useful in quantifying the symptom burden pre- and post-intervention to enable a comparative study between somatic movement therapy and core strengthening exercises. The PSST has proven to be of high internal consistency with a Cronbach alpha typically being reported to be greater than 0.9, which verifies the reliability and validity of the PSST in both clinical and research contexts.

    Measured: 6 weeks

  3. WHOQOL-BREF Questionnaire

    The WHOQOL-BREF is a standardized tool developed by the World Health Organization to assess quality of life across four domains: physical health, psychological health, social relationships, and environment. The tool is most applicable in measuring global shifts in well-being, which is critical in assessing the overall impact of interventions on women with PMS. WHOQOL-BREF scores can be used to indicate improvement in mood, pain, stress levels, and physical functioning. The instrument has been tested using a wide range of populations and languages and demonstrated to be highly reliable (Cronbach alpha consistently above 0.7 in all domains) and content and construct validity, which makes it a suitable instrument to assess the quality of life in this study.

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2026
  2. Study start5 May 2025
  3. Primary completion5 Aug 2026 (estimated)
  4. Study completion15 Aug 2026 (estimated)

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07642232
Sponsor's protocol ID
REC/RCR & AHS/25/0526
Status last verified
Jun 2026
First submitted
8 Jun 2026
Last updated
11 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Maharaj S, Trevino K. A Comprehensive Review of Treatment Options for Premenstrual Syndrome and Premenstrual Dysphoric Disorder. J Psychiatr Pract. 2015 Sep;21(5):334-50. doi: 10.1097/PRA.0000000000000099.

    PubMed 26352222
  • Tiranini L, Nappi RE. Recent advances in understanding/management of premenstrual dysphoric disorder/premenstrual syndrome. Fac Rev. 2022 Apr 28;11:11. doi: 10.12703/r/11-11. eCollection 2022.

    PubMed 35574174
  • Siahbazi S, Montazeri A, Taghizadeh Z, Masoomie RJJoRiM, Science D. The consequences of premenstrual syndrome on the quality of life from the perspective of affected women: a qualitative study. 2018;6(2):284-92.

  • Itriyeva K. Premenstrual syndrome and premenstrual dysphoric disorder in adolescents. Curr Probl Pediatr Adolesc Health Care. 2022 May;52(5):101187. doi: 10.1016/j.cppeds.2022.101187. Epub 2022 May 6.

    PubMed 35534402
  • Liguori F, Saraiello E, Calella P. Premenstrual Syndrome and Premenstrual Dysphoric Disorder's Impact on Quality of Life, and the Role of Physical Activity. Medicina (Kaunas). 2023 Nov 20;59(11):2044. doi: 10.3390/medicina59112044.

    PubMed 38004093

Questions about this trial

What is this clinical trial studying?

A study testing Group A (Somatic Movement Therapy) and Group B (Core Strengthening Exercise) in people with Premenstrual Syndrome, run by Riphah International University at 1 site in Pakistan.

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 4 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: looking for participants now, as of the sponsor's last update on 11 Jun 2026. 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 Pakistan. 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 Imran Amjad, PHD* (03324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Perceived Stress Scale (PSS-10) (time frame: 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07642232, which also lists 5 linked publications.

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 11 Jun 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in