NCT07642232

Brief 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 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started May 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
May 2025Aug 2026

Study Start

First participant enrolled

May 5, 2025

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 8, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 5, 2026

Expected
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2026

Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

1.3 years

First QC Date

June 8, 2026

Last Update Submit

June 8, 2026

Conditions

Keywords

Core Strengthening ExercisesPerceived StressQuality of LifeSomatic Movement Therapy

Outcome Measures

Primary Outcomes (3)

  • 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 .

    6 weeks

  • 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.

    6 weeks

  • 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.

    6 weeks

Study Arms (2)

Group A: Somatic Movement Therapy (SMT)

ACTIVE COMPARATOR

Participants 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.

Other: Group A (Somatic Movement Therapy)

Group B: Core Strengthening Exercises

EXPERIMENTAL

Participants 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

Other: Group B (Core Strengthening Exercise)

Interventions

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.

Group B: Core Strengthening Exercises

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 A: Somatic Movement Therapy (SMT)

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ghurki Trust Hoapital

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

Related Publications (5)

  • 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.

    PMID: 26352222BACKGROUND
  • 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.

    PMID: 35574174BACKGROUND
  • 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.

    BACKGROUND
  • 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.

    PMID: 35534402BACKGROUND
  • 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.

    PMID: 38004093BACKGROUND

MeSH Terms

Conditions

Premenstrual Syndrome

Condition Hierarchy (Ancestors)

Menstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Maryam Zahid, MS*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad, PHD*

CONTACT

Imran Amjad, PHD*

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2026

First Posted

June 11, 2026

Study Start

May 5, 2025

Primary Completion (Estimated)

August 5, 2026

Study Completion (Estimated)

August 15, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations