The Effects of Chiropractic on Quality of Life, Sleep and Pain in Pregnant Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Pittsburgh Sleep Quality Index (PSQI)
研究概览
简要总结
Objective: The aim of this study is to investigate the effectiveness of Chiropractic care on pain, quality of life and sleep in pregnant women compared to a control group.
The study is designed as non-randomized controlled trial. Forty-two pregnant women at least on the 14th week of gestation will be included. Control group will include women receiving regular care, but no chiropractic care. Care will extend for 4 weeks.
Outcomes measures include sleep quality, pain and quality of life questionnaires.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •pregnant women over the age of 18
- •of at least 14 weeks gestation,
- •with a good understanding of English, Spanish or French.
排除标准
- •women over the age of 45,
- •pregnancies of more than 35 weeks gestation
- •high-risk pregnancies (tobacco, alcohol or substance use, diagnosed medical conditions or high blood pressure).
结局指标
主要结局
Pittsburgh Sleep Quality Index (PSQI)
时间窗: 4 weeks
The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire, which evaluates sleep quality and disturbances over a period of one month. It is composed of nineteen individual items creating seven subcategories: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, daytime dysfunction and the total PSQI score.
SF-36 questionnaire Quality of Life
时间窗: 4 weeks
The Short Form-36 Health Survey (SF-36) is one of the most frequently used and evaluated health-related quality of life measures for pregnancy. It is composed of 36 questions (items) that evaluate both positive and negative states of health. The questionnaire assesses eight dimensions: physical functioning, role limitation from physical health problems, bodily pain, general health, vitality, social functioning, and role limitation from emotional health problems
Numeric pain rating scale
时间窗: 4 weeks
The Numeric Rating Scale (NRS) is among the most commonly used measures of pain intensity in clinical and research settings. The NRS is an 11-point scale, from 0 to 10 with 0 indicating "no pain" and 10 representing the "worst imaginable pain". Participants select the number that best represents their pain intensity.
次要结局
未报告次要终点
研究者
Pablo Perez de la Ossa
Head of Research
Barcelona College of Chiropractic