Insomnia
Conditions
Brief summary
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.
Interventions
OTHERThermal spa treatment
The thermal spa center in Balaruc-les-Bains offers 15 different thermal treatments tailored to each patient's specific needs. A structured protocol of four daily treatments over 18 days is established for each patient to ensure appropriate care. These treatments may be adjusted during the course of the spa program without compromising therapeutic objectives. They are divided into two categories according to the temperature of the thermal water used.
Sponsors
Clinique Beau Soleil
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nighttime sleep duration | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | Total nighttime sleep duration during a typical night, self-reported by the participant and expressed in hours. |
| Number of nocturnal awakenings | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment. | Number of awakenings occurring during a typical night of sleep, self-reported by the participant and expressed as the number of awakenings per night. |
| Sleep satisfaction | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment. | Overall sleep satisfaction assessed using a visual numeric scale ranging from 0 (very poor sleep quality) to 10 (excellent sleep quality), expressed as a score from 0 to 10. |
| Pain Assessment Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | Pain will be assessed using a Visual Numeric Rating Scale (NRS). This self-assessment tool is simple, reproducible, and sensitive to changes in pain intensity. It provides a quantitative yet subjective measure of pain. The numeric rating scale ranges from 0 to 10, where 0 corresponds to no pain and 10 to the worst imaginable pain. Participants select the number that best represents their current level of pain. The chosen number reflects the intensity of pain experienced. |
| Hospital Anxiety and Depression Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Hospital Anxiety and Depression Scale (HADS) is a screening tool used to assess levels of anxiety and depression in patients. It consists of 14 items divided into two subscales: 7 items for anxiety (HADS-A) and 7 items for depression (HADS-D). Each item is scored from 0 to 3, resulting in a total score ranging from 0 to 21 for each subscale. |
| Pichot Fatigue Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Pichot Fatigue Scale is a self-assessment tool used to measure physical and mental fatigue in individuals. It is commonly used in the follow-up of patients with chronic conditions, psychiatric disorders such as depression, or chronic fatigue syndromes. The scale consists of 8 items, each rated from 0 to 4 according to the intensity of the symptom experienced. It is a simple, quick instrument (less than 5 minutes to complete) and provides a reliable measure to quantify fatigue and monitor its evolution over time. |
| Epworth Sleepiness Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Epworth Sleepiness Scale assesses a patient's likelihood of falling asleep in eight everyday situations. It measures daytime sleepiness. A total score greater than 10 is considered indicative of excessive daytime sleepiness. |
| EuroQol 5 Dimensions | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The EQ-5D-5L is a self-administered questionnaire assessing health-related quality of life across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension includes five severity levels ranging from no problems to extreme problems/unable to perform. Responses define a five-digit health state that can be converted into a utility index score ranging from values below 0 to 1.00, with higher scores indicating better health status. |
| EuroQol Visual Analogue Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | Perceived health is assessed using the EQ Visual Analogue Scale (EQ-VAS), ranging from 0 (worst imaginable health state) to 100 (best imaginable health state), with higher scores indicating better perceived health. |
| Clinical Global Impression - Improvement Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Clinical Global Impression - Improvement scale assesses overall change in a patient's clinical condition following an intervention compared with baseline. Scores range from 1 (very much improved) to 7 (very much worse), with lower scores indicating greater improvement. |
| Perceived Stress Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Perceived Stress Scale (PSS-10), developed by Cohen, Kamarck, and Mermelstein in 1983, is a psychometric instrument used to measure the level of stress perceived by an individual over the past month. It consists of 10 items derived from the original 14-item version (PSS-14). The scale assesses subjective stress perception by evaluating the frequency of stress-related thoughts and feelings. Responses are rated on a scale from 0 (never) to 4 (very often). |
| International Restless Legs Syndrome Severity Scale | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The International Restless Legs Syndrome Rating Scale IRLS assesses the severity of restless legs syndrome by evaluating symptom intensity frequency and impact on daily functioning and quality of life. The score ranges from 0 to 40 with higher scores indicating greater symptom severity. |
| Physical Activity Questionnaire | At baseline (Day 0), Day 18 (end of treatment), and 2 months after completion of treatment | The Ricci and Gagnon Physical Activity Questionnaire assesses an individual's level of physical activity using questions on the frequency intensity and duration of daily activities. The total score ranges from 0 to 45 with higher scores indicating higher levels of physical activity. Scores lower than 18 indicate inactivity scores between 18 and 35 indicate an active lifestyle and scores above 35 indicate a very active lifestyle. |
Outcome results
None listed