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

NCT ID: NCT07304544

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-01

Study Completion Date

2024-12-30

Brief Summary

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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)

Detailed Description

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Conditions

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Colostomy Complications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Intervention Group

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

Group Type EXPERIMENTAL

RAM-based nursing

Intervention Type BEHAVIORAL

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

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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RAM-based nursing

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhigang Lan

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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West China Hospital

Chengdu, Sichuan, China

Site Status

Countries

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China

Other Identifiers

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WestChinaH-SJ-2025-01

Identifier Type: -

Identifier Source: org_study_id