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| Name | Class |
|---|---|
| Oura health oy | UNKNOWN |
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The objective of this research study is to show whether data given by Oura ring could be used to objectively measure patients pain and well-being before and after disc surgery.
The study will consist of a total 30 disc prolapse patients. Patients are given Oura rings along with other treatment. Patients use Oura rings before and after disc surgery. Patients will also fill Beck Depression Inventory (BDI) and pain detect inquiries in the beginning and in the end of study. Patients symptoms will also be followed daily by electrical symptom diary.
Oura rings technology is based on photoplethysmography( PPG). PPG is a noninvasive method to detect blood volume changes in the microvascular bed of tissue. PPG waveform varies by respiration, sympathetic nervous system activity and thermoregulation. Oura ring gives information of patients activity level, calorie consumption, steps count, resting heart rate,heart rate variability, respiration rate, body temperature, sleep depth and quality of sleep.
Data collected with Oura ring after disc surgery will be compared to data collected before surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | All patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oura ring | Device | Photopletysmography based noninvasive device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in heart rate variability | collected from Oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in resting mean heart rate | collected from Oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in ventilatory rate | collected from oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in sleep onset latency | collected from oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in sleep efficiency | percentage of the time spent asleep while in bed collected from oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in number of nighttime awakenings | collected from oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in total sleep time | collected from oura ring | comparison of mean value prior to surgery and one month after surgery |
| Change in sleep stages (awake, light sleep, deep sleep and rem sleep) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BDI questionnaire points | BECK Depression Inventory (Scale 1-63, higher scores mean a worse outcome) | one month prior surgery and one month after surgery |
| Change in pain questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients from Finland
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tommi Bergman, Md | Contact | 0331166356 | tommi.bergman@pshp.fi | |
| Jarkko Harju, md, phd | Contact | jarkko.harju@fimnet.fi |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampere university hospital | Recruiting | Tampere | Pirkanmaa | 33521 | Finland |
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| ID | Term |
|---|---|
| D010146 | Pain |
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
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percentages of each sleep stages collected from oura ring |
| comparison of mean value prior to surgery and one month after surgery |
| Change in symptoms based on symptom diary | Daily symptom diary kept by patient | prior surgery and one month after surgery |
Descriptive questionnaire
| one month prior surgery and one month after surgery |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |