Study of the Influence of an Osteopathic Treatment Protocol on the Improvement of Sleep: a Double-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
研究概览
简要总结
Sleep deprivation, which is a universal necessity, has serious physiological consequences.
Sleep disorders are among the most common health problems, and yet they are often neglected. The osteopathic treatment results in vasodilation, muscle relaxation and increased blood flow, resulting in improved range of motion, decreased pain perception and/or tissue changes. Thus, osteopathy ensures improved physical and mental health, which consequently helps patients with their sleep disorders.
详细描述
Humans spend about a third of their lives sleeping, but most individuals know little about sleep. Sleep deprivation, which is a universal necessity, has serious physiological consequences.
Based on behavioral and physiological criteria, human sleep is divided into two phases: Non Rapid Eye Movement (NREM) and Rapid Eye Movement (REM).
NREM sleep corresponds to 75% to 80% of sleep and REM approximately 20% to 25% of sleep, existing between four to six episodes.
Sleep disorders are among the most common health problems, and yet they are often neglected. It is estimated that millions of people suffer chronically from a sleep or wakefulness disorder, impairing their health and longevity.
According to the International Classification of Sleep Disorders (ICSD) there are eight categories of sleep disorders and clinical history is essential for diagnosis, including family history, medical, psychiatric, neurological or substance abuse disorders.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
In the distribution of the volunteers to the groups, the participants chose between two numbered envelopes, opaque and sealed, in order to guarantee the confidentiality of the allocation, to which group they belonged. Inside each envelope is a piece of paper with the group, control group or intervention group.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have sleep disorders (insomnia);
- •Volunteers between 18 and 30 years of age.
排除标准
- •Attending the 3rd or 4th year of the Osteopathy Course;
- •Present fever (axillary or oral temperature higher than 37.5º C);
- •Have a history of skull fracture;
- •Have a history of bleeding and intracranial hemorrhage;
- •Have a diagnosis of convulsion.
结局指标
主要结局
Change from baseline in Sleep Quality assessed with the Pittsburgh Sleep Quality Index
时间窗: 7 days post-intervention
The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality, measures several different aspects of sleep.
次要结局
未报告次要终点
研究者
Natália Maria Oliveira Campelo
Professor
Escola Superior de Tecnologia da Saúde do Porto