Effects of Mind Body Exercises in Pregnant Women

Not Applicable

Recruiting

• Conditions: Pregnancy Related

• Registration Number: NCT06750406
• Lead Sponsor: Riphah International University

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2024-08-01
• Status Verified: 2024-12
• Study First Submitted: 2024-12-20
• Study First Submitted QC: 2024-12-20
• Last Update Submitted: 2024-12-20
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-07-01
• Study Completion: 2025-08-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 34

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Perceived- Stress Scale (PSS)	8th week	The PSS has shown good internal consistency, with Cronbach's alpha coefficients typically ranging from 0.70 to 0.90. Test-retest reliability over short intervals (e.g., a few days to a month) is generally acceptable, with correlation coefficients often above 0.70.The PSS correlates well with other measures of stress and related constructs, demonstrating good construct validity. High PSS scores have been associated with increased risk for health problems and psychological issues, indicating good predictive validity
Hamilton Anxiety Rating Scale (HARS)	8th week	The HARS has demonstrated good internal consistency, with Cronbach's alpha coefficients typically ranging from 0.74 to 0.96. Inter-rater reliability is high, with intraclass correlation coefficients often above 0.80. Test-retest reliability over periods of days to weeks is generally good, with correlation coefficients often above 0.75.The HARS covers a broad range of anxiety symptoms, ensuring good content validity. It correlates well with other measures of anxiety and related constructs, demonstrating good construct validity. The HARS scores are consistent with clinical diagnoses of anxiety disorders, indicating good concurrent validity
Fatigue Severity Scale (FSS)	8th week	The FSS has shown excellent internal consistency, with Cronbach's alpha coefficients typically above 0.90. Test-retest reliability over periods ranging from a few days to several weeks is generally high, with correlation coefficients often above 0.80.The FSS includes items that comprehensively cover the domain of fatigue, ensuring good content validity. It correlates well with other measures of fatigue and related constructs, demonstrating good construct validity. The FSS scores are consistent with clinical assessments of fatigue severity, indicating good concurrent validity

Trial Locations

Locations (1)

Ishaq Haroon hospital and Goshea shifa hospital; 🇵🇰 Lahore, Punjab, Pakistan