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| Name | Class |
|---|---|
| Hospital ClÃnico Universitario de Santiago de Compostela | UNKNOWN |
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The proposed project is a prospective quasi-experimental study to be conducted at the Ostomy Clinic of the University Hospital Complex of Santiago de Compostela. The primary objective is to evaluate the effectiveness of health education as a nursing intervention in reducing anxiety and depression and improving the quality of life of ostomy patients following digestive surgery. The study will focus on adult patients who have undergone an elimination ostomy, excluding terminal patients and those with cognitive impairments.
The study involves clinical follow-up of patients from hospital admission to several months after completing the health education program. Validated scales will be used to measure quality of life, anxiety, and depression. The intervention will consist of health education workshops and continuous follow-up by specialized nursing staff.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health education by virtual and smart-glasses | Experimental | Health education (emotional care, mindfulness, jacobson, quality of life, social, sexual, ...). Method: psicosocial/holistic |
|
| Control | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Health Education | Other | Session 1 (60 minutes) Patient Knowledge Assessment: Review understanding of ostomy care, including nutrition, device management, and early identification of stoma/skin complications. Feedback and Support: Address gaps in knowledge based on ostomy consultations. Skills Workshop: Build confidence and self-efficacy in daily care, reducing anxiety about complications. Session 2 (60 minutes) Mental Health and Quality of Life: Explain the link between ostomy and mental health; identify and manage anxiety/depression symptoms; promote healthy habits and social integration. Mindfulness and Stress Management: Teach breathing and relaxation techniques to manage stress and improve body acceptance. Guided Visualization: Focus on acceptance and confidence building. Action Plan: Summarize techniques and encourage regular practice. Session 3 Healthy Habits: Nutrition, exercise, rest, and stress management. Social Integration: Communication, participation, and support networks. Closing: Summary, resou |
| Measure | Description | Time Frame |
|---|---|---|
| Beck Depression Inventory | Beck Depression Inventory | Baseline and at 3 months |
| 36-Item Short Form Health Survey | 36-Item Short Form Health Survey | Baseline and at 3 months |
| Beck anxiety inventory | Beck anxiety inventory | Baseline and at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Complejo Hospitalario Universitario de Santiago de Compostela | Santiago de Compostela | A Coruña | 15703 | Spain |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2024 |
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|
| Jan 8, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2024 | Jan 8, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D003110 | Colonic Neoplasms |
| D003093 | Colitis, Ulcerative |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D015212 | Inflammatory Bowel Diseases |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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