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临床试验/NCT07085026
NCT07085026招募中不适用

The Effect of Yoga Practiced in the Third Trimester on Sleep and Stress

Istanbul University - Cerrahpasa1 个研究点 分布在 1 个国家目标入组 112 人开始时间: 2025年8月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
112
试验地点
1
主要终点
Sleep Quality

研究概览

简要总结

Many physiological and psychological changes occur during pregnancy. Sleep and stress are among these changes and can negatively impact the pregnancy process. Yoga can improve sleep quality and stress levels during pregnancy. The purpose of this study was to evaluate the effects of yoga, implemented in the third trimester of pregnancy according to World Health Organization guidelines, on sleep and stress.

详细描述

Pregnancy is defined as a period of both physiological and psychological changes in women. Although pregnancy and childbirth are natural processes, the physical, mental, and emotional adaptive changes that occur during this time can significantly impact a woman's health and pregnancy outcomes. Sleep problems are common during pregnancy. Toward the end of pregnancy, women often experience frequent nighttime awakenings, insomnia, and restless sleep. During pregnancy, women undergo bio-physio-psychosocial changes that can lead to increased stress. In order to prevent adverse outcomes, it is important to manage stress in pregnant women and implement interventions aimed at reducing high cortisol levels.

Yoga can be defined as a system of stretching exercises and postures (asanas) combined with deep breathing (pranayama) and meditation, aiming to unify the mind, body, and spirit.

There are studies that have evaluated the effects of yoga practice during pregnancy on sleep and stress. None of these studies have reported any negative effects of yoga on pregnancy. In all studies, yoga was applied with varying frequencies, durations, and techniques. However, no study has been found that evaluates the effects of a yoga program conducted in accordance with the recommendations of the World Health Organization (WHO, 2023) on both sleep and stress. Therefore, the aim of this study is to evaluate the effects of yoga, implemented during the third trimester of pregnancy in line with WHO guideline recommendations, on sleep and stress.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

盲法说明

Because of the behavioral and observable characteristics of the intervention (yoga in the third trimester of pregnancy), neither assessment nor blinding of investigators was performed.

入排标准

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

入选标准

  • •Voluntarily agreed to participate in the study,
  • •Aged between 18 and 35 years,
  • •In the third trimester of pregnancy (between 29 and 42 weeks of gestation),
  • •Able to read and write in Turkish,
  • •No prior experience with yoga practice.

排除标准

  • •High-risk pregnancy,
  • •In the first or second trimester,
  • •Multiple pregnancy,
  • •Any condition that prevents yoga practice (e.g., restrictions on physical activity),
  • •Previous experience with yoga practice

研究组 & 干预措施

Intervention Group

Experimental

Participants in this group will practice yoga in accordance with the WHO guideline recommendations.

干预措施: Yoga Intervention (Behavioral)

Control Group

No Intervention

Participants in this group will not receive yoga; routine care will be provided.

结局指标

主要结局

Sleep Quality

时间窗: It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.

Sleep quality is measured by the Pittsburgh Sleep Quality Index (PSQI). The Pittsburgh Sleep Quality Index (PSQI) was developed to assess sleep quality and sleep disturbances over the past month. It consists of a total of 24 questions, 19 of which are self-rated items. The remaining 5 questions are used for clinical evaluation and are not included in the scoring. Each item in the scale is rated on a scale from 0 to 3. From the 19 self-rated items, 7 component scores are derived. Some components are based on a single item, while others are formed by combining several items. These components are: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The total score of the scale is obtained by summing the scores of these 7 components. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. A total score greater than 5 indicates "poor sleep quality."

次要结局

  • Perceived Stress Level(It will be assessed at baseline (in the third trimester of pregnancy) and on day 30 after the yoga intervention.)

研究者

发起方
Istanbul University - Cerrahpasa
申办方类型
Other
责任方
Principal Investigator
主要研究者

Gözde Şengün

Master's Degree Student with Thesis, Istanbul University- Cerrahpasa Midwifery Department

Istanbul University - Cerrahpasa

研究点 (1)

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