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临床试验/NCT03125850
NCT03125850已完成不适用

Comparative Study of Psychology and Glaucoma Knowledge in Glaucoma Day-ward Patients Inpatients

Zhongshan Ophthalmic Center, Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2017年8月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
240
试验地点
1
主要终点
Change of glaucoma knowledge score

研究概览

简要总结

This study will compare the glaucoma day-ward patients' efficacy with inpatients by evaluating the glaucoma knowledge and psychology , and will analysis the reasons of the differences. Half of participants will receive treatment in day-ward, while the other half will receive treatment in hospital.

详细描述

Ophthalmic surgery has short operative time, quick recovery, and small anesthesia risk, making day case surgery the main management mode of ophthalmic surgery. This study will explore the differences of psychology and glaucoma knowledge between glaucoma day-ward patients and the inpatients. The data will be collected by scale on admission and discharge.

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
None

入排标准

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

入选标准

  • Patient is diagnosed with glaucoma;
  • Will receive glaucoma surgery;
  • Voluntary participation in this study;
  • Have enough language comprehension ability;
  • Best corrected visual acuity reach 0.1 or better;
  • Patient or his legal representative has sign the informed consent.

排除标准

  • Patient with mental disorder;
  • There are important viscera function failure or other serious disease, including clinical related coronary artery disease, cardiovascular disease or myocardial infarction into the group of the first six months; serious neurological or psychiatric illness; serious infections; coagulant function abnormality; general active infectious diseases; malignant tumor; serious immune diseases;
  • Patient with monocular blindness;
  • Axial length≤20 mm;
  • With other serious eye diseases;
  • Neurologic diseases that could affect the visual field;
  • 3 months prior to research to participate in any clinical study;
  • Researchers think not suitable to participate in this clinical trial subjects;
  • Refused to sign the informed consent.

结局指标

主要结局

Change of glaucoma knowledge score

时间窗: at baseline and 1 hour before discharge

The outcome will be measured by The Gray Glaucoma Knowledge Questionaire. This quesionanire has a total maximum score of 17, with higher scores representing better knowledge.

Change of depression and anxiety score

时间窗: at baseline and 1 hour before discharge

The outcome will be measured by The Hospital Depression and Anxiety Scale (HADS). It consists of two subscales: HDAS-anxiety and HADS-depression. Each item is srored from 0-3, with higher scores indicating a higher level of depression and anxiety. For each of the seven-item subscales, the minimum sum score is 0, and the maximum is 21.

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

Mingkai Lin

chief physician

Zhongshan Ophthalmic Center, Sun Yat-sen University

研究点 (1)

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