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SIngle-centre interventional single-blinded randomized controlled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio) and to be carried out with volunteers that present alterations in the quality of sleep. Eligible and accepting subjects participating in the study will be assigned to receive an osteopathic treatment protocol or a placebo technique
Intervention protocol in the intervention group:
The intervention protocol consists of 4 techniques that will be performed according to the following order:
Intervention protocol in the control group:
Placebo technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Group of patients that will receive the 4 techniques proposed to evaluate the changes on sleep quality |
|
| Control group | Sham Comparator | Group of patients that will receive a sham technique |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Osteopathic treatment protocol | Other | The intervention protocol consists of 4 techniques that will be performed according to the following order:
|
| Measure | Description | Time Frame |
|---|---|---|
| Sleep Quality | Sleep quality is measured using the Pittsburgh Sleep Quality Index before the intervention and one month after, having received three treatment sessions. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Heart Rate Variability | Changes in Heart Rate Variability (HRV) that will be measured and monitored before and at the end of the intervention using a portable HRV monitoring device (polar H10) that sends the signal to a computer for its collection and analysis through the Kubios HRV software | 1 month |
| Perceived Stress |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ramón Mateos Alpuente | Contact | +34 620768645 | info@ramonmateos.es |
| Name | Affiliation | Role |
|---|---|---|
| Ramón Mateos Alpuente | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ramón Mateos Fisioterapia y OsteopatÃa | Recruiting | Zaragoza | 50009 | Spain |
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| ID | Term |
|---|---|
| D012893 | Sleep Wake Disorders |
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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SIngle-centre interventional single-blinded randomized contsubjectsrolled trial, with random assignment of the subjects in two groups (intervention and control, 1: 1 ratio)
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Eligible and recruited patients will be Randomized using OxMaR software (Oxford Minimization and Randomization).
|
| Sham technique | Other | Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes. |
|
Assessment of perceived stress using the Cohen's Perceived Stress Scale (PSS), which will be completed before the first intervention and one week after completing the three planned interventions. |
| 1 month |
| D001523 | Mental Disorders |
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |