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NCT Number: NCT07304544

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

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)

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Key information

Conditions

Colostomy Complications

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West China Hospital

Chengdu, Sichuan, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RAM-based nursing

Behavioral

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

Primary outcomes

  1. Self-Rating Anxiety Scale (SAS) score

    Time frame: Week 12

    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).

  2. Self-Rating Depression Scale (SDS)

    Time frame: 12 weeks

    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).

Secondary outcomes

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

    Time frame: Week 12

    • 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 26, 2025
Registry last updated
Dec 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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