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
Sponsor study identifier
interventional
115
1 country
1
Study Start
December 1, 2022
Actual (reported)Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 30, 2024
Actual (reported)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)
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2024
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 1, 2022
Actual (reported)December 1, 2024
Actual (reported)December 30, 2024
Actual (reported)December 2, 2025
Actual (reported)December 26, 2025
Actual (reported)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
World Health Organization Quality of Life-Brief Interpretation(WHOQOL-BREF) scores
Week 12
On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks
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.
On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
West China Hospital
Chengdu, Sichuan, China
115 participants (actual enrollment reported by the registry).
First Submitted
December 2, 2025
First Posted
December 26, 2025
Study Start
December 1, 2022
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 1, 2024
Actual (reported)Study Completion
December 30, 2024
Actual (reported)Last Updated
December 26, 2025
Record last verified: 2025-12
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Source: ClinicalTrials.gov.
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