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临床试验/NCT06189300
NCT06189300已完成不适用

The Effect of Telephone Education and Counseling to Individuals With Stoma on Stoma Compliance and Complications: Randomized Controlled Study

Cukurova University1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2024年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
66
试验地点
1
主要终点
The effect of education and counseling given to individuals with stoma on complications.

研究概览

简要总结

The study will be conducted on individuals with stoma followed in the stoma therapy outpatient clinic of a university hospital. The effect size calculated based on the preliminary data was 2.955, indicating a very large effect. Therefore, to obtain a more conservative sample size estimate, an effect size of 0.80 was used for the a priori power analysis, in accordance with Cohen's convention for a large effect size. The sample size was calculated using G*Power version 3.1.9.7, with a significance level of α = 0.05 and a statistical power (1 - β) of 0.85. Accordingly, the required sample size was determined as 30 participants per group. The Ostomy Adjustment Inventory and Pittman Ostomy Complication Severity Index will be completed. The scales will be collected for both groups on the first day, first month, and third month postoperatively. Patients were contacted five times postoperatively to provide education and counseling. SPSS will be used for data analysis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

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

  • Having undergone stoma surgery in a university hospital,
  • No vision or hearing problems,
  • Verbal communication is possible,
  • Without diagnosed psychiatric problems.

排除标准

  • Want to leave the research

研究组 & 干预措施

Telephone Education

Experimental

Training and consultancy will be provided

干预措施: Education and counseling intervention (Other)

Control

No Intervention

Standard care will be given

结局指标

主要结局

The effect of education and counseling given to individuals with stoma on complications.

时间窗: 1 and 3 mounth

Pittman Ostomy Complication Severity Index will be used. This valid and reliable index was developed by Joyce Pittman in 2014 to evaluate the frequency and severity of complications developing in the early postoperative period during the follow-up period of individuals with a stoma. A higher total score indicates more serious ostomy complications. The lowest score that can be obtained from the scale is 0, while the highest score is 92.

The effect of education and counseling given to individuals with stoma on stoma compliance.

时间窗: 1 and 3 mounth

Ostomy Adjustment Inventory will be used. The lowest score that can be obtained from the scale is 0, while the highest score is 92.This valid and reliable scale was developed to determine the adaptation levels of individuals with stoma. A high score from the scale means that compliance is high.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seyma Yurtseven

Clinic Nurse

Cukurova University

研究点 (1)

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