Clinical trial NCT06750406: Effects of Mind Body Exercises in Pregnant Women
Official title: Effects of Mind Body Exercises on Stress, Anxiety and Fatigue in Pregnant Women
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pregnancy Related
Keywords: pregnant women
exercises
yoga
anxiety
fatigue
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-12-27
Enrollment: 34
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: his Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. the participants will be divided into two groups. Group A will be involved in mind body exercises and group B will be given relaxation exercises

Detailed description: This Study is a randomized controlled trial (RCT) which will be collected through non probability convenient sampling technique and will be carried out for 10 months duration with a sample size of 34 pregnant women which will be collected through non probability convenient sampling technique. Sample will be collected from Gosha shifa and Ishaq Haroon Hospital. Pregnant women in their second trimester (between 14-28 weeks). Age between 20 to 35 years. Able to understand and participate in mind-body exercises sessions will be included. High-risk pregnancies (e.g., gestational diabetes, hypertension). Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders). will be excluded. Tools used in the study are perceived stress scale (PSS) , Hamilton Anxiety Rating Scale (HARS) and Fatigue severity scale-(FSS).Data will be analyzed by busing SPSS 26.0

Eligibility criteria: Inclusion Criteria:

* Pregnant women in their second trimester (between 14-28 weeks)
* Primi gravid
* Able to understand and participate in mind-body exercises sessions

Exclusion Criteria:

* High-risk pregnancies (e.g., gestational diabetes, hypertension)
* Pre-existing medical conditions that could interfere with participation (e.g., severe musculoskeletal disorders)
* History of psychiatric disorders requiring ongoing treatment
* History of miscarriage

Primary outcomes:
measure: Perceived- Stress Scale (PSS)
timeFrame: 8th week
measure: Hamilton Anxiety Rating Scale (HARS)
timeFrame: 8th week
measure: Fatigue Severity Scale (FSS)
timeFrame: 8th week
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ishaq Haroon hospital and Goshea shifa hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: hina gul, MSOMPT
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Oyarzabal I, Zabala-Lekuona A, Mota AJ, Palacios MA, Rodriguez-Dieguez A, Lorusso G, Evangelisti M, Rodriguez-Esteban C, Brechin EK, Seco JM, Colacio E. Magneto-thermal properties and slow magnetic relaxation in Mn(II)Ln(III) complexes: influence of magnetic coupling on the magneto-caloric effect. Dalton Trans. 2022 Aug 30;51(34):12954-12967. doi: 10.1039/d2dt01869a.
citation: Guo P, Zhang X, Liu N, Wang J, Chen D, Sun W, Li P, Zhang W. Mind-body interventions on stress management in pregnant women: A systematic review and meta-analysis of randomized controlled trials. J Adv Nurs. 2021 Jan;77(1):125-146. doi: 10.1111/jan.14588. Epub 2020 Oct 13.
citation: Lerdal A. Fatigue severity scale. Encyclopedia of quality of life and well-being research: Springer; 2021. p. 1-5.