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The goal of this randomized controlled trial is to learn if the Roy Adaptation Model (RAM) nursing program improves anxiety, depression, and quality of life in adults who have recently received a colostomy. It will also learn about changes in stress and inflammation-related blood markers. The main questions it aims to answer are:
Does 12-week RAM nursing lower anxiety and depression scores compared with routine nursing? Does RAM nursing raise quality-of-life scores and beneficially alter blood levels of cortisol, IL-6, TNF-α, serotonin, and dopamine? Researchers will compare RAM nursing (one-to-one education, cognitive-behavioral support, family training, and phone follow-up) to routine stoma-care education only.
Participants will:
Receive either RAM nursing or routine nursing for 12 weeks Complete anxiety, depression, and quality-of-life questionnaires at baseline and week 12 Provide blood samples at baseline and week 12 to measure stress and inflammation markers (which was a routine test for normal colostomy patients)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks |
|
| Control group | No Intervention | Received routine post-colostomy nursing for 12 weeks: (1) Stoma care: Guidance on stoma cleaning, ostomy bag replacement, and observation of stoma color and secretion; (2) Physiological care: Pain management, dietary guidance, and prevention of postoperative complications (e.g., infection, constipation); (3) Routine health education: Distribution of stoma care manuals and brief psychological comfort. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RAM-based nursing | Behavioral | On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Self-Rating Anxiety Scale (SAS) score | Sum the scores of all 20 items. The total score ranges from 20 to 80. A cut-off score of 50 indicates significant anxiety,the higher the score,the higher the anxiety level (scores ≥50 suggest anxiety symptoms). | Week 12 |
| Self-Rating Depression Scale (SDS) | Sum the scores of all 20 items. The total score ranges from 20 to 80. A cut-off score of 53 indicates significant depression. The higher the score, the depression level is higher(scores ≥53 suggest depressive symptoms). | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| World Health Organization Quality of Life-Brief Interpretation(WHOQOL-BREF) scores |
|
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Chengdu | Sichuan | China |
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| Week 12 |