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临床试验/NCT02040389
NCT02040389已完成不适用

Visual Guidelines and Tutoring in Pediatric Urological Surgery

Shaare Zedek Medical Center1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年3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
120
试验地点
1
主要终点
Level of parents anxiety

研究概览

简要总结

The aim of this study is checking impact of visual guidelines (picture book) and tutoring in pediatric urologic surgery

详细描述

The number of operations in pediatric urology performed on the basis of one day surgery has been increased tremendously over the last years. The shortening of the hospital admission intends to increase the efficacy of the health system, however at the same time puts an additional burdening regarding the postoperative care on the parents of the operated children. The parents often have no or has little experience with regards to the basic medical education. The lack of the proper tutoring in terms of possible complications, normal postoperative period may cause unnecessary patients and parents anxiety, visit to the emergency room or calls to the medical stuff, and in some case delay medical attention which can cause major surgery related complications. Visual guidelines and tutoring of the patients upon surgery may avoid these undesirable effects of the early hospital discharge

Patients and methods:

The investigators are proposing prospective study of 3 groups of patients which undergo the most often urological surgery Group 1 penile surgery, Group 2 inguinal surgery. Group 3 renal surgery required nephrostomy tube leave or drainage. Each group will be divided into two subgroups (20 patients each) with and without visual tutoring prior to the surgery. Visual tutoring will include the photograph pictures reflecting different stage of the convalescent period following surgery. The parents will be asked to answer on questionnaire regarding the level of anxiety before surgery, immediately after surgery, week and 3-6 months after surgery. The number of parents calls to the hospital staff, emergency or outpatient clinic visit will be recorded and compared between two groups. The statistical analysis will performed utilizing Graph Pad Prism version 5.00 for Windows, (Graph Pad software, San Diego, California, chi square and Fisher test), considering p value of <0.05 as significant).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
2 Months 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •children with indications for penile, inguinal or kidney surgery

排除标准

  • •prior urological procedure (recurrent cases)

研究组 & 干预措施

pictures book + standard education

Active Comparator

arm with children undergoing urological procedures and their parents will receive standard preoperative education + pictures book with pictures of surgical wound in different stages of healing

干预措施: Picture book (Behavioral)

Standard preoperative education

Active Comparator

Arm with children undergoing urological procedures and their parents will receive only standard preoperative education

干预措施: Standard preoperative education (Behavioral)

结局指标

主要结局

Level of parents anxiety

时间窗: Three weeks after surgery

Measuring of parents anxiety 3-6 weeks after surgery

Level of parents anxiety

时间窗: Thirty minutes before surgery

The following parameters will be compared between two groups: level of parents anxiety by questionnaire, numbers of parents calls to the hospital staff and non-planed visits to emergency department/outpatient clinic

Level of parents anxiety

时间窗: Fifteen minutes after surgery

Measuring of parents anxiety in recovery room after surgery

Level of parents anxiety

时间窗: Week after surgery

Measuring of parents anxiety one week after surgery

次要结局

  • Numbers of parents non-planed calls/visits(During 3-6 weeks after surgery)
  • Numbers of parents non-planed calls/visits(During a week before surgery)
  • Numbers of parents non-planed calls/visits(During 48 hours after surgery)
  • Numbers of parents non-planed calls/visits(0ne week after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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