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Trans Cutanous Electric Nerve Stimulation of Auricular Vagus Nerve
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| auricular vagus stimulation | Experimental | Transcutanous Electrial Nerve Stimulation |
|
| Sham | Sham Comparator | Sham Stimulation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transcutanous Auricular vagus nerve stimulation | Device | Non-invasive Auricular Vagus Stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum Interleukin-6 (IL-6) | serum Interleukin-6 levels will be measured using (ELIZA) | Baseline and after 4 weeks of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Waist Circumference | Measurement of waist circumference in centimeters as an indicator of central adiposity | Baseline and after 4 weeks of intervention |
| Body Shape Index (ABSI) | Assessment of body shape using A Body Shape Index calculated from waist circumference, height, and weight. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lamiaa Z Salama, MSc | Contact | 01099793264 | lamiasalama064@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Nessreen G Al-Nahas, Professor | Cairo University | Principal Investigator |
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Individual participant data will not be shared
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| Sham | Device | Non working device |
|
| Baseline and after 4 weeks of intervention |
| Depression Anxiety Stress Scale (DASS-21) Score | Evaluation of psychological status including depression, anxiety, and stress using the validated Depression Anxiety Stress Scale -21 questionnaire Higher scores indicate greater severity of emotional state The total score represents the sum of all 21 items multiplied by two. Sub scale scores for depression, anxiety and stress will be calculated and analyzed separately. | Baseline and after 4 weeks of intervention |
| Pittsburgh Sleep Quality Index (PSQI) | Assessment of sleep quality using the Pittsburgh Sleep Quality Index questionnaire. The total score ranges from 0 to 21 Score greater than 5 indicate poor sleep quality. | Baseline and after 4 weeks of intervention |
| Gut Feeling Questionnaire Score | Evaluation of gut-related symptoms and gut-brain interaction using a gut feeling questionnaire The total score is calculated by summing all questionnaire items, with higher scores indicating worse gut feelings. | Baseline and after 4 weeks of intervention |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |