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临床试验/CTRI/2024/08/072957
CTRI/2024/08/072957已完成不适用

Association OF Low Back Pain, Restless Leg Syndrome and Insomnia in Third Trimester Females: A Cross-sectional study

Sahil Sharma1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2024年9月27日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
272
试验地点
1
主要终点
Oswestry Disability Index (ODI)

研究概览

简要总结

This study will be conducted over 6 months period. The data will be collected from different OPDs of Maharishi Markandeshwar Medical College and Hospital, Solan, Himachal Pradesh. A total of 272 pregnant females in their third trimester of pregnancy with history of low back pain, restless leg syndrome and insomnia will be recruited. Prior to administrating the questionnaire, a written informed consent will be obtained from each pregnant female. Each participant will undergo small interview method after that participant will be provided with an information sheet explaining the merits and demerits of participating in the study as well as any foreseen benefits. After that, sociodemographic and anthropometric data such as age, height, weight will be measured. Before administering the questionnaire, each participant will undergoing a small interactive interview with principal investigator. Principal investigator will be providing all the information regarding the questionnaire and how to answer the questions. This procedure will take ~ 30 minutes for complete gathering of data.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 35.00 Year(s)(—)
性别
Female

入选标准

  • 1 Gestational age between 28 to 40 weeks 2 Female with any history of low back pain, restless leg syndrome, insomnia during third trimester 3 Females with pain score on Numeric pain rating scale more than 5.

排除标准

  • 1 Women with any previous history of low back pain 2 Any history of surgical intervention of lumbar spine 3 History of carcinoma 4 Spinal deformities 5 Pelvic fracture.

结局指标

主要结局

Oswestry Disability Index (ODI)

时间窗: At baseline

次要结局

  • Restless Leg Syndrome Questionnaire (Rating Scale)(At baseline)
  • Sleep Quality Scale (SQS)(At baseline)

研究者

发起方
Sahil Sharma
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Sahil Sharma

Maharishi Markandeshwar Medical College and Hospital Kumarhatti Solan

研究点 (1)

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