Study on the Impact of Roy Adaptation Model Nursing on Psychological State and Quality of Life of Post-Colostomy Patients and Exploration of Its Mechanism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Self-Rating Anxiety Scale (SAS) score
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Underwent elective colostomy (permanent or temporary) due to colorectal cancer, inflammatory bowel disease, or intestinal obstruction;
- •Postoperative time ≤ 1 week;
- •Age 18-75 years;
- •Consciousness clear, able to communicate normally and complete questionnaire surveys;
- •Voluntarily participate in the study and sign informed consent.
排除标准
- •Complicated with severe cardiovascular, liver, kidney, or mental diseases;
- •History of anxiety, depression, or other mental disorders before surgery;
- •Stoma complications (e.g., stoma prolapse, ischemia, infection) requiring reoperation;
- •Loss to follow-up or refusal to cooperate with the study
结局指标
主要结局
Self-Rating Anxiety Scale (SAS) score
时间窗: Week 12
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).
Self-Rating Depression Scale (SDS)
时间窗: 12 weeks
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).
次要结局
- World Health Organization Quality of Life-Brief Interpretation(WHOQOL-BREF) scores(Week 12)
研究者
Zhigang Lan
Professor
West China Hospital