- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07642232
Effects of Somatic Movement Therapy vs Core Strengthening in Premenstrual Syndrome
Effects of Somatic Movement Therapy Versus Core Strengthening Exercises on Symptom Severity, Perceived Stress, and Quality of Life in Premenstrual Syndrome
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Imran Amjad, PHD*
- Telefonní číslo: 03324390125
- E-mail: imran.amjad@riphah.edu.pk
Studijní záloha kontaktů
- Jméno: Imran Amjad, PHD*
- Telefonní číslo: 0515481826
- E-mail: imran.amjad@riphah.edu.pk
Studijní místa
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Punjab Province
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Lahore, Punjab Province, Pákistán, 54000
- Nábor
- Ghurki Trust Hoapital
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Kontakt:
- Ghulam Fatima, PhD*
- Telefonní číslo: 03034073057
- E-mail: ghulam.fatima@riphah.edu.pk
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Group A: Somatic Movement Therapy (SMT)
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.
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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.
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Experimentální: Group B: Core Strengthening Exercises
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
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Perceived Stress Scale (PSS-10)
Časové okno: 6 weeks
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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 .
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6 weeks
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Premenstrual Symptoms Screening Tool (PSST)
Časové okno: 6 weeks
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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.
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6 weeks
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WHOQOL-BREF Questionnaire
Časové okno: 6 weeks
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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.
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6 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Maryam Zahid, MS*, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- 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.
- 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.
- 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.
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
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Další relevantní podmínky MeSH
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