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临床试验/NCT01383629
NCT01383629已完成不适用

The Effect of Preoperative Counseling on Patient Fear From Visual Experience During Vitrectomy Surgery Under Regional Anesthesia

University of Malaya2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Patient fear

研究概览

简要总结

This RCT aims to study the effect of preoperative counselling in reducing patients fear and visual perception during vitrectomy under local anaesthesia.

详细描述

This was a single-blinded, randomised clinical trial conducted at University of Malaya Medical Centre, Kuala Lumpur, Malaysia, and approved by the Institutional Review Board of the hospital. Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included. Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

After obtaining informed consent, patients were randomised to two groups: Group A received additional preoperative counseling while Group B did not receive any additional counseling. Both groups received routine preoperative counseling regarding potential risks and benefits of vitrectomy by an ophthalmologist one day prior to the operation.

The information covered during counselling and the method of delivery were standardised for all patients. An ophthalmologist reviewed the patient one day prior to the operation and patients who were randomised to additional counselling were counselled regarding the possible visual perceptions that they might encounter during surgery. These included lights, colours, movements, flashes, instruments and surgeon's hands or face. Twenty four hours after the surgery, another ophthalmologist blinded to the patient randomisation interviewed the patients on their visual perceptions during surgery using a standard questionnaire. Patients were interviewed regarding the types of visual sensations they perceived and if they caused fear to them. Patients were asked to grade their fear based on a visual analogue scale. The fear was graded from 0 to 10, with a score of 0 meaning no fear and a score of 10 being the maximum or extreme fear. At the end of the questionnaire the interviewer was allowed to ask the patient if he or she has received preoperative counselling and if they prefer to be or not to be counselled. Patients were asked to describe in details the images and objects that they saw during the operation. The data were analyzed using SPSS version 17.0.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Supportive Care
盲法
Triple (Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-75 years scheduled for vitrectomy under regional anaesthesia were included

排除标准

  • Patients who could not understand English, who had psychiatric illness or mental retardation, or who refused to give consent were excluded.

结局指标

主要结局

Patient fear

时间窗: 1 week

Patient fear during surgery is measured on a visual analogue scale

次要结局

  • Type of visual perception during vitrectomy surgery under local anaesthesia(1 week)

研究者

申办方类型
Other

研究点 (2)

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