NCT07289841

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 15, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 17, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 10, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2026

Completed
Last Updated

April 14, 2026

Status Verified

April 1, 2026

Enrollment Period

4 months

First QC Date

December 4, 2025

Last Update Submit

April 11, 2026

Conditions

Keywords

Skills Discharge ChecklistAdaptationDischargeOstomyQuality of life

Outcome Measures

Primary Outcomes (1)

  • Descriptive characteristics form

    This form includes 10 questions covering age, gender, marital status, education level, social security, occupation, the clinic where the patient was hospitalized, whether the surgery was emergency or elective, and the type of ostomy.

    12 weeks

Secondary Outcomes (2)

  • Ostomy Adaptation Scale (OAS)

    12 weeks

  • Stoma Quality of Life Scale (SQLS)

    12 weeks

Study Arms (2)

The group that used the Stoma Management Skills Discharge Checklist.

EXPERIMENTAL

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

Other: Stoma Management Skills Discharge Checklist used

The group that follows the standard discharge process

NO INTERVENTION

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

Interventions

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 used the Stoma Management Skills Discharge Checklist.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mersin Şehir Eğitim ve Araştırma Hastanesi

Mersin, Yenişehir, 33100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Asst.Prof.

Study Record Dates

First Submitted

December 4, 2025

First Posted

December 17, 2025

Study Start

December 15, 2025

Primary Completion

April 10, 2026

Study Completion

April 10, 2026

Last Updated

April 14, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations