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

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

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)

Study Overview

• Status: Completed
• Conditions: Colostomy Complications
• Intervention / Treatment: Behavioral: RAM-based nursing

• Study Type: Interventional
• Enrollment (Actual): 115
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Chengdu, Sichuan, China
      • West China Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks	Behavioral: RAM-based nursing; On the basis of routine nursing, RAM-based nursing was implemented for 12 weeks
No Intervention: Control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
World Health Organization Quality of Life-Brief Interpretation(WHOQOL-BREF) scores	Reverse Scoring: For item 6 (pain/discomfort), reverse the score (1=5, 2=4, 3=3, 4=2, 5=1) because higher scores on this item indicate poorer quality of life. All other items are scored as per the original response.; Domain Scores: Calculate the average score for each domain (Physical Health: Items 1-8; Psychological Health: Items 9-14; Social Relationships: Items 15-17; Environmental Domain: Items 18-26).; Standardization: Convert each domain average score to a standard score (0-100) using the formula: Standard Score = [(Average Score - 1) / 4] × 100. Higher standard scores indicate better quality of life in that domain.	Week 12

Collaborators and Investigators

• Sponsor: West China Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2022
• Primary Completion (Actual): December 1, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: December 2, 2025
• First Submitted That Met QC Criteria: December 11, 2025
• First Posted (Actual): December 26, 2025

Study Record Updates

• Last Update Posted (Actual): December 26, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: WestChinaH-SJ-2025-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No