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临床试验/CTRI/2024/03/064752
CTRI/2024/03/064752进行中(未招募)1/2 期

Salutogenic Effect of Yoga Therapy on Sleep Deprivation in Antenatal Mothers

未提供1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年4月1日最近更新:

试验速览

阶段
1/2 期
状态
进行中(未招募)
入组人数
60
试验地点
1
主要终点
1.Effective changes in sleep deprivation symptoms.

研究概览

简要总结

The methodology for this study will involve recruiting antenatal mothers visiting OG OPD ,MGMCRI and randomly assigning them to yoga intervention group or control group. The yoga intervention group will participate in a structured yoga program biweekly for 12 weeks specifically designed for antenatal women, while the control group will receive standard prenatal care without the yoga intervention.

Data Collection: Data will be collected through a combination of self-reported measures and objective assessments. Participants will be asked to complete questionnaires Pittsburgh sleep quality index (PSQI), The Functional Outcomes of Sleep Questionnaire (FOSQ),  Sense of Coherence (SOS) before and after the intervention. In addition, physiological measures such as, Maternal examination, Metabolic Parameter, Obstetrics scan report (Fetal ultrasound Scan) from Maternal & fetal hospital routine antenatal checkup (from hospital patient case sheet) will be recorded to assess the impact of the yoga intervention. Statistical analysis will be conducted to compare the outcomes between the yoga intervention group and the control group..

**Ethical Considerations :**This study will adhere to all ethical guidelines and ensure that participants’ confidentiality and well-being are protected. Informed consent will be obtained from all participants, and the study will be approved by the relevant ethics committee.

Conclusion

By investigating the effectiveness of a yoga intervention in antenatal mothers, this study aims to provide valuable insight into the potential benefits of yoga for this population. The findings from this research could have implications for antenatal care and contribute to the development of holistic approaches to support the physical and mental well-being of expectant mothers.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 40.00 Year(s)(—)
性别
Female

入选标准

  • Gestation age from 22nd weeks.
  • Low-risk primigravida/pregnancy.

排除标准

  • High-risk pregnancy and Infertility cases under treatment, precious pregnancy
  • Multigravida Pregnant women.
  • Those who are known cases of psychiatric disorder, epilepsy, medical and Obstetrics complications.

结局指标

主要结局

1.Effective changes in sleep deprivation symptoms.

时间窗: 12 weeks

2.Effective changes in overall sleep quality.

时间窗: 12 weeks

3.Effective changes of daytime sleepiness on activities of daily living

时间窗: 12 weeks

次要结局

  • 1.Changes in maternal cardiovascular and respiratory changes.(2. Stress level of antenatal mothers)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

Dr Vasundhara V R

Institute of Salutogenesis and Complementary Medicine(ISCM),Sri Balaji Vidyapeeth University

研究点 (1)

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