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

NCT07304544 | Completed DMC

• 1 other identifier: WestChinaH-SJ-2025-01
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Colostomy Complications

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• World Health Organization Quality of Life-Brief Interpretation(WHOQOL-BREF) scores

  Week 12

Study Arms (2)

Intervention Group

EXPERIMENTAL

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

Behavioral: RAM-based nursing

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.

Interventions

RAM-based nursing BEHAVIORAL

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• West China Hospital: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuan, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 26, 2025
• Study Start: December 1, 2022
• Primary Completion: December 1, 2024
• Study Completion: December 30, 2024
• Last Updated: December 26, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)