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临床试验/NCT06750406
NCT06750406已完成不适用

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

Riphah International University1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
1
主要终点
Perceived- Stress Scale (PSS)

研究概览

简要总结

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

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

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

排除标准

  • •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

研究组 & 干预措施

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

干预措施: 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

干预措施: relaxation exercises (Other)

结局指标

主要结局

Perceived- Stress Scale (PSS)

时间窗: 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)

时间窗: 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)

时间窗: 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

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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