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临床试验/NCT07289841
NCT07289841已完成不适用

Integration of Ostomy Management Skills Discharge Checklist Into Patient Education and Its Effect on Stoma Adaptation and Quality of Life

Neslihan Özcanarslan1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年12月15日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Descriptive characteristics form

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

The group that used the Stoma Management Skills Discharge Checklist.

Experimental

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

干预措施: Stoma Management Skills Discharge Checklist used (Other)

The group that follows the standard discharge process

No Intervention

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

结局指标

主要结局

Descriptive characteristics form

时间窗: 12 weeks

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.

次要结局

  • Ostomy Adaptation Scale (OAS)(12 weeks)
  • Stoma Quality of Life Scale (SQLS)(12 weeks)
  • Ostomy Adaptation Scale (OAS)(12 weeks)
  • Stoma Quality of Life Scale (SQLS)(12 weeks)

研究者

发起方
Neslihan Özcanarslan
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Neslihan Özcanarslan

Asst.Prof.

Toros University

研究点 (1)

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