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Clinical Trials/NCT06750406
NCT06750406CompletedNot Applicable

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

Riphah International University1 site in 1 country34 target enrollmentStarted: August 1, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
34
Locations
1
Primary Endpoint
Perceived- Stress Scale (PSS)

Study Overview

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 35 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

mind body exercises

Experimental

The intervention consists of a structured program of mind-body exercises designed specifically for pregnant women. This involves 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 eight weeks

Intervention: mind body exercises (Other)

Relaxation exercises

Active Comparator

this includes Awareness about relaxation exercises including relax postures and generalized exercise interventions. The duration of these sessions will be 45 to 60 minutes each, with a recommended frequency of 2-3 times per week for eight weeks

Intervention: relaxation exercises (Other)

Outcomes

Primary Outcomes

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

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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