Discharge Checklist for Stoma Management Skills

NCT ID: NCT07289841

Last Updated: 2025-12-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-15
• Study Completion Date: 2026-05-01

Brief Summary

The aim of this study was to develop an Ostomy Management Skills Discharge Checklist and to prospectively compare individuals who received this list with those who received standard discharge training to monitor its impact on ostomy compliance and quality of life. The study hypotheses were: The developed Stoma Management Skills Discharge Checklist is more effective than standard discharge training in improving ostomy compliance in individuals with stoma.

H1: It is more effective in improving the quality of life in individuals with stoma.

Detailed Description

This is a quasi-experimental, prospective study to be conducted between December 2025 and March 2026. An analytical approach will be employed. As part of the study, an Ostomy Management Skills Discharge Checklist will be developed, and individuals who received this list will be prospectively compared with those who received standard discharge training to monitor their adaptation to ostomy and their impact on quality of life.This study will be conducted with patients who underwent new intestinal stomas in the General Surgery, Gastroenterology Surgery, and Surgical Oncology departments of Mersin City Training and Research Hospital. Patients will be selected using the purposive sampling method among those who underwent new stomas (colostomies or ileostomies) after surgery. The sample size was calculated based on data from a pilot study with 10 patients using r = 1 (equal sample size for both groups), α = 5%, and 90% power. The sample size was calculated using the formula N = α(Zα/2 + Z1-β)² (r + 1) / r d² (N = (1 + 1) × (1.96 + 0.84)² × 2 × (1.2)² / [1 × (1.6 - 1.4)²]). As a result of the calculation, 32 patients per group were determined for 90% power. A total of 80 patients with new ostomies were included in the study. 40 of these patients will form Group 1, which will be followed with the standard discharge process, and the other 40 will form Group 2, whose discharge is planned based on the Stoma Management Skills Discharge Checklist.

The study provides all patients with the same discharge education. Group 1 receives standard education without a checklist, while Group 2 is evaluated with the Stoma Management Skills Discharge Checklist to objectively assess readiness for discharge. Patients must reach a sufficient level in all checklist steps, and any missing skills are re-taught individually. About one month after discharge, both groups are assessed for ostomy adaptation and quality of life. Data are collected by the surgical unit nurse responsible for ostomy patients through 15-20-minute face-to-face interviews in a quiet room.

Data will be analyzed using IBM SPSS Statistics 22. Frequencies (number, percentage) will be used for categorical variables, and descriptive statistics (mean, standard deviation) for numerical variables. Normality of numerical variables will be assessed through skewness and kurtosis values; values within ±1.5 will be considered normally distributed, therefore parametric tests will be applied. Relationships between two independent categorical variables will be evaluated with the Chi-Square test, and Fisher's Exact test will be used when Chi-Square assumptions are not met. A significance level of 0.05 will be used for all analyses.

Conditions

Over 18 Years Old

Keywords

Skills Discharge Checklist; Adaptation; Discharge; Ostomy; Quality of life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

The group that used the Stoma Management Skills Discharge Checklist.

The Stoma Management Skills Discharge Checklist will be used during discharge.

Group Type: EXPERIMENTAL

Stoma Management Skills Discharge Checklist used

Intervention Type: OTHER

It is seen that there is no structured discharge checklist that systematically evaluates the knowledge and skill levels of stoma patients during the discharge process and there are no comprehensive studies addressing the impact of such a list on stoma adaptation and quality of life.

The group that follows the standard discharge process

Discharge checklist will not be applied, it will be in the standard discharge process

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Stoma Management Skills Discharge Checklist used

It is seen that there is no structured discharge checklist that systematically evaluates the knowledge and skill levels of stoma patients during the discharge process and there are no comprehensive studies addressing the impact of such a list on stoma adaptation and quality of life.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients over 18 years old
• Patients with a new stoma
• Admitted to General Surgery, Gastrointestinal Surgery, or Surgical Oncology departments
• Discharged with only a stoma
• Without comorbidities
• Alive after surgery
• Able to independently manage their stoma care

Exclusion Criteria

• Visual impairments (e.g., partial blindness, advanced cataracts)
• Physical impairments (e.g., tremors, Parkinson's disease, stroke)
• Intellectual disabilities

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neslihan Özcanarslan

OTHER

Sponsor Role: lead

Responsible Party

Neslihan Özcanarslan

Asst.Prof.

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Neslihan ÖZCANARSLAN, Phd

Role: CONTACT

Phone: +905336671604

Email: neslihan.ozcanarslan@toros.edu.tr

Other Identifiers

22.06.2022/129

Identifier Type: -

Identifier Source: org_study_id