跳至主要内容
临床试验/NCT07195136
NCT07195136已完成不适用

Investigation of the Effect of Orange Blossom Essential Oil Placed in the Stoma Bag on Odor Removal, Social Isolation, and Stoma Adaptation in Individuals With Stoma

Cukurova University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月18日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Stoma Adaptation Scale

研究概览

简要总结

Because the stoma will become a part of the individual's body and directly impact their quality of life, careful attention should be paid to its location and surgical procedure. Stoma care nurses should provide effective training to patients and those responsible for their care. Patients and their families should be regularly monitored, followed up, and cared for at home after discharge. They should also be provided with information about appropriate units to consult if any problems arise. Stoma support groups should be established to foster social interaction. A well-planned surgical procedure protects individuals from the development of complications and problems that can be considered a "life sentence."

详细描述

This prospective, randomized, controlled study aims to investigate the effects of orange blossom essential oil placed in the stoma bag on odor reduction, social isolation, and stoma compliance in individuals with permanent colostomies. Sample size calculations were performed using a priori power analysis (t-test) for the intervention and control groups. Accordingly, with an effect size of d=1.12, a 5% error rate (α=0.05), and 80% power (1-β=0.80), the minimum sample size for both groups was calculated as 54. Considering potential losses, the total sample size will be increased by 10%, with 30 patients in each group (Experimental Group: 30, Control Group: 30), for a total of 60 patients. Data will be collected using a patient personal information form, a patient information form, a compliance scale for individuals with stoma, and a social isolation scale, all prepared by the researchers based on literature.

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)

盲法说明

Blind

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

  • Volunteer to participate in the study
  • Over 18 years of age
  • With a stoma
  • No stoma-related complications

排除标准

  • Leaving the study

结局指标

主要结局

Stoma Adaptation Scale

时间窗: 30 day

Scale items are scored between 0 and 4. The minimum score is 0 and the maximum is 92. A higher score indicates greater compliance with the stoma.

Social Isolation Scale

时间窗: 30 day

Scale items are scored on a 1-3 scale. The minimum score is 14 and the maximum is 42. As the score increases, the level of social isolation increases.

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

Meltem Akbaş

Dr

Cukurova University

研究点 (1)

Loading locations...

相似试验