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

West China Hospital115 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

115

Conditions

Colostomy Complications

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: 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).

Time frame: 12 weeks

Secondary Outcomes

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

1. 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. 2. 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). 3. 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.