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临床试验/NCT04327856
NCT04327856已完成不适用

The Assessment of Types and Intensity of Unpleasant Experiences Pre-, Intra-, and Postoperatively in the Patients Undergoing Cataract Surgery, Using Especially Designed Questionnaire.

Medical University of Bialystok2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2020年2月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
The intensity of unpleasant experiences pre-, intra-, and postoperatively

研究概览

简要总结

Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.

Strategic aim: formulation of algorithm and modification of perioperative approach to patient qualified to undergo phacoemulsification procedure.

详细描述

Untreated cataract - the most common reason for an operation in the world - leads to continual decrease in vision, eventually may be the cause of blindness. This condition always requires surgical intervention that involves phacoemulsification with intraocular lens implantation. The procedure takes short amount of time and is performed using topical anaesthesia. Phacoemulsification can be characterised as highly efficient and safe. Besides that, it is still not free from burdens to the patient: causing increased stress levels and anxiety, discomfort or pain, and other symptoms, as surgery is performed on fully conscious and alert patients. Despite, there's lots of research concentrating on patient's quality of life, with different health conditions, the subject of patient's experiences during cataract surgery hasn't been yet fully investigated and explored.

The aim of the study will be an assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.

Strategic aim: formulation of algorithm and modification of perioperative approach to patient qualified to undergo phacoemulsification procedure.

The prospective questionnaire data will be collected for 200 adults: women and men, that were qualified for cataract surgery in Ophthalmology Department of the Białystok University Clinical Hospital, as an elective surgery with patients being qualified based on specific qualifying criteria.

Based on the questionnaire, that have 128 detailed questions, sociodemographic characteristic of patients will be created, and they will be divided into two groups (I and II) depending whether they are undergoing first or second eye surgery. Juxtaposition of different patients experiences and sensations, with their sociodemographic characteristics, as an implication, will lead to identification of factors that cause surgical procedure to be described either as positive or negative experience. The questionnaire is facilitated also selection of the most significant and frequent reasons for dissatisfaction.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • The criteria for inclusion required non complicated cataracts (NC1, NC2) according to The Lens Opacities Classification System III (LOCS III scale). Additional inclusion criteria were as follows: documented progression of best corrected visual acuity less than 0.6 according to Snellen notification
  • patient agreement to participate in the study after informing them about the nature of the research

排除标准

  • bilateral deafness that prevented any communication with the patient;
  • no logical contact with the patient (mental disorders, senile dementia, etc.);
  • any conditions that might complicate the surgery: post-inflammatory or post-traumatic cataract, chronic corneal disease and corneal opacity that prevent intraoperative vision, advanced disease macular degenerative, active inflammatory process, pregnancy, general steroid therapy.
  • lack of patient consent to participate in the study.

结局指标

主要结局

The intensity of unpleasant experiences pre-, intra-, and postoperatively

时间窗: 3 hours post operation

Assessment of types and intensity of unpleasant experiences pre-, intra-, and postoperatively in the patients undergoing cataract surgery, using especially designed questionnaire.

次要结局

未报告次要终点

研究者

发起方
Medical University of Bialystok
申办方类型
Other
责任方
Sponsor

研究点 (2)

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