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NCT Number: NCT06750406

Effects of Mind Body Exercises in Pregnant Women

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

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Key information

Conditions

Pregnancy Related Anxiety Disorders Behavior Fatigue Mental Disorders Motor Activity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ishaq Haroon hospital and Goshea shifa hospital

Lahore, Punjab Province, 6400, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mind body exercises

Other

intervention might consist of a structured program of mind-body exercises designed specifically for pregnant women. This could involve a combination of yoga sessions, mindfulness meditation practices, deep breathing exercises, and progressive muscle relaxation techniques. The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for 8 weeks

Relaxation exercises

Other

It involves relaxation exercises including deep breathing, relaxing postures etc. The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for 8 weeks

Primary outcomes

  1. Perceived- Stress Scale (PSS)

    Time frame: 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

  2. Hamilton Anxiety Rating Scale (HARS)

    Time frame: 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

  3. Fatigue Severity Scale (FSS)

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Effects of Mind Body Exercises on Stress, Anxiety and Fatigue in Pregnant Women

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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