Study of the Effect of Spa Therapy on Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- Insomnia Severity Index
研究概览
简要总结
Many spa patients report falling asleep more easily, experiencing fewer nighttime awakenings, and feeling more refreshed upon waking after their treatment. However, these effects have never been formally evaluated in a scientific study. The aim of this study is therefore to measure precisely the impact of the spa treatment on the severity of insomnia.
The study does not modify usual care. Participants follow their prescribed spa treatment as planned. They are simply asked to complete questionnaires:
- before the start of the treatment
- at the end of the 18-day program
- and 2 months later
The main questionnaire assesses the severity of insomnia. Additional questionnaires evaluate sleep quality, fatigue, pain, anxiety, stress, and quality of life.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals following an 18-day thermal spa program
- •Signed non-opposition form
- •Affiliation with the French Social Security system or an equivalent healthcare coverage
- •Insomnia Severity Index (ISI) score ≥ 8
排除标准
- •Individuals deprived of their liberty by law
- •Individuals under legal guardianship or trusteeship
- •Individuals with cognitive impairment
- •Individuals unable to complete written questionnaires in French
- •Uncontrolled cardiovascular disease
- •Active infectious condition
- •Immunocompromised patients
- •Patients with chronic inflammatory rheumatic disease during an active flare
- •Severe general health impairment, including cachexia
研究组 & 干预措施
Insomia Cohort
干预措施: Thermal spa treatment (Other)
结局指标
主要结局
Insomnia Severity Index
时间窗: At baseline (Day 0), and Day 18 (end of treatment)
This instrument assesses the severity and consequences of insomnia through 5 questions. Each item is rated on a five-point Likert scale ranging from 0 to 4. Higher total scores indicate greater insomnia severity (0-7: no insomnia; 8-14: subthreshold insomnia; 15-21: moderate insomnia; 22-28: severe insomnia).
次要结局
- Number of nocturnal awakenings(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.)
- Sleep satisfaction(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment.)
- Nighttime sleep duration(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Pain Assessment Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Hospital Anxiety and Depression Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Pichot Fatigue Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Epworth Sleepiness Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- EuroQol 5 Dimensions(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- EuroQol Visual Analogue Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Clinical Global Impression - Improvement Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Perceived Stress Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- International Restless Legs Syndrome Severity Scale(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)
- Physical Activity Questionnaire(At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment)