Roy Adaptation Model in Post-Colostomy Care: Mind & Life Impact

Sichuan University

Status: Completed

Conditions: Colostomy Complications

Treatments: Behavioral: RAM-based nursing

Study type: Interventional

Funder types: Other

Identifiers

NCT07304544

WestChinaH-SJ-2025-01

Details and patient eligibility

About

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)

Enrollment: 115 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups

Intervention Group

Experimental group

Description:

On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks

Treatment:

Behavioral: RAM-based nursing

Control group

No Intervention group

Description:

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.