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动画视听材料辅助的术前教育对改善学龄前儿童全身麻醉应用研究
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注册号:

Registration number:

ChiCTR1900025116 

最近更新日期:

Date of Last Refreshed on:

2019-08-12 

注册时间:

Date of Registration:

2019-08-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

动画视听材料辅助的术前教育对改善学龄前儿童全身麻醉应用研究 

Public title:

Application for animated audio-visual material assisted preoperative education in improving general anesthesia for preschool children 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

动画视听材料辅助的术前教育对改善学龄前儿童全身麻醉应用研究 

Scientific title:

Application for animated audio-visual material assisted preoperative education in improving general anesthesia for preschool children 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

金约西 

研究负责人:

金约西 

Applicant:

Yuexi Jin 

Study leader:

Yuexi Jin 

申请注册联系人电话:

Applicant telephone:

+86 13858868682 

研究负责人电话:

Study leader's telephone:

+86 0577-88068946 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

fagei@163.com 

研究负责人电子邮件:

Study leader's E-mail:

fagei@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

浙江省温州市鹿城区学院西路270号 

研究负责人通讯地址:

浙江省温州市鹿城区学院西路270号 

Applicant address:

270 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang 

Study leader's address:

270 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang 

申请注册联系人邮政编码:

Applicant postcode:

325000 

研究负责人邮政编码:

Study leader's postcode:

325000 

申请人所在单位:

温州医科大学附属眼视光医院 

Applicant's institution:

The Eye Hospital of Wenzhou Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

2019-105-K-98 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

温州医科大学附属眼视光医院伦理委员会 

Name of the ethic committee:

Ethics Committee of The Eye Hospital of Wenzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-08-01 

伦理委员会联系人:

谷佩秋 

Contact Name of the ethic committee:

Peiqiu Gu 

伦理委员会联系地址:

浙江省温州市鹿城区学院西路270号 

Contact Address of the ethic committee:

270 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0577-88075582 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

EYE_ec.126.com 

研究实施负责(组长)单位:

温州医科大学附属眼视光医院 

Primary sponsor:

The Eye Hospital of Wenzhou Medical University 

研究实施负责(组长)单位地址:

浙江省温州市鹿城区学院西路270号 

Primary sponsor's address:

270 Xueyuan Road West, Lucheng District, Wenzhou, Zhejiang 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

浙江

市(区县):

温州

Country:

China

Province:

Zhejiang

City:

Wenzhou

单位(医院):

温州医科大学附属眼视光医院

具体地址:

浙江省温州市鹿城区学院西路270号

Institution
hospital:

The Eye Hospital of Wenzhou Medical University

Address:

270 Xueyuan Road West, Lucheng District

经费或物资来源:

温州医科大学附属眼视光医院 

Source(s) of funding:

The Eye Hospital of Wenzhou Medical University 

研究疾病:

术前焦虑 

Target disease:

Preoperative anxiety 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

探索性研究/预试验 

Study phase:

研究目的:

本研究旨在评价动画视听材料辅助的术前教育在降低儿童及家长术前焦虑、增加麻醉前配合、减少术后躁动率、提高治疗过程满意度等方面的有益效果。 

Objectives of Study:

This study aimed to determine the beneficial effect of viewing an audio-visual animation introduction in reducing the preoperative anxiety, increasing pre-anesthesia cooperation and reducing surgery post-incitement rate of both children and their parents, while improving the satisfaction with the treatment process. 

药物成份或治疗方案详述:

1.选择择期行斜弱视手术患儿200例,随机分成M组常规术前访视(group M,n=100)、S组术前访视后进行动画视听材料辅助的术前教育(group S,n=100)。 2.两组患儿:a、采用耶鲁围术期焦虑量表(mYPAS)在术前访视(T1),手术室等候区(T2),麻醉诱导前(T3)三个时间点进行焦虑水平评估;b、采用诱导期合作度量表(ICC)在T3时间点评定诱导期合作程度;c、围术期生命体指标:记录术前一小时在病房及入室后2min的血压及脉搏;d、术后苏醒期躁动评估采用五点的分级法评分;e、采用术后行为量表(PHBQ)在术后一周、一个月两个时间点进行行为评分。 3.患儿家属焦虑采用状态-特质焦虑问卷分别在T1、T2两个时间点评估。 4.通过对各组患者的比较,了解不同的缓解焦虑方法对围手术期心理、麻醉各阶段配合程度、术后行为人格的影响。 5.通过对两组儿童心理状况的比较,探讨儿童心理状况的差异,探索对学龄前儿童更安全、更可靠的降低术前焦虑新方法。 

Description for medicine or protocol of treatment in detail:

1. This study will recruit 200 pre-school children schedule for strabismus surgery. The subjects are randomly divided into two groups. The control group (M group) with routine preoperative visits, the experimental group (S group) accept the same preoperative visits with additional audio-visual animation materials to assist preoperative education. 2. Assessment of anxiety levels was performed by applying MYPAS to all subjects at three time points:Preoperative visit (T1), at waiting area of operating room(T2), before anesthesia induction (T3). The degree of induction cooperation is determined by ICC at T3. Perioperative vital signs, blood pressure and pulse, will be recorded at the 1 hour before the operation when patients were in the wards and 2 minutes after entering the operation room. Postoperative agitation after recovery is assessed by a 5-point grading score. PHBQ is adopted to score behavior one week and one month after surgery. 3. The anxiety of Patients families is evaluated at two time points (T1 and T2). 4. Compare the subjects in each group to understand the effects of different methods of relieving anxiety on perioperative psychology, degree of cooperation in various stages of anesthesia, and postoperative behavioral personality. 5. Compare the psychological status of the two groups of children, explore the differences in children's psychological status, and explore a new method for reducing preoperative anxiety that is safer and more reliable for preschool children. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. 择期全麻下行斜视矫正术患儿为研究对象; 2. 年龄4-6岁,已接受学龄前幼儿教育; 3. 患儿家属文化水平在高中及以上水平,未离异; 4. 患儿家属了解本研究目的,并同意参加本研究。 

Inclusion criteria

1. Children schedule for strabismus surgery under general anesthesia; 2. Aged 4-6 years, and had received preschool education; 3. The family members' level of education is at the high school level and above, and they were not divorced; 4. The family members understood the purpose of the study and agreed to participate in the study. 

排除标准:

父母亲存在认知障碍、精神异常或身体残疾,患儿既往麻醉手术史,未进行学龄前教育患儿、精神障碍、发育迟缓、先天性心脑血管疾病和智力低下的患儿。 

Exclusion criteria:

The parents have cognitive impairment, mental disorder or physical disability. Children with previous anesthesia operation history, children without preschool education, children have mental disorder, stunting, congenital cardiovascular and cerebrovascular diseases and mental retardation. 

研究实施时间:

Study execute time:

From2019-07-01To 2019-12-31 

征募观察对象时间:

Recruiting time:

From2019-08-20To 2019-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

100

Group:

Control group

Sample size:

干预措施:

常规术前访视

干预措施代码:

Intervention:

routine preoperative visits

Intervention code:

组别:

试验组

样本量:

100

Group:

Experimental group

Sample size:

干预措施:

动画视听材料辅助的术前教育

干预措施代码:

Intervention:

animated audio-visual material assisted preoperative education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

浙江 

市(区县):

温州 

Country:

China 

Province:

Zhejiang 

City:

Wenzhou 

单位(医院):

温州医科大学附属眼视光医院 

单位级别:

三级甲等 

Institution
hospital:

The Eye Hospital of Wenzhou Medical University  

Level of the institution:

Tertiary A 

测量指标:

Outcomes:

指标中文名:

改良耶鲁围术期焦虑量表评分

指标类型:

主要指标 

Outcome:

score of mYPAS

Type:

Primary indicator 

测量时间点:

术前访视(T1),手术室等候区(T2),麻醉诱导前(T3)

测量方法:

调查问卷

Measure time point of outcome:

Preoperative visit (T1), at waiting area of operating room(T2), before anesthesia induction (T3)

Measure method:

questionnaire

指标中文名:

状态-特质焦虑问卷评分

指标类型:

次要指标 

Outcome:

score of STAI

Type:

Secondary indicator 

测量时间点:

术前访视(T1),手术室等候区(T2)

测量方法:

调查问卷

Measure time point of outcome:

Preoperative visit (T1), at waiting area of operating room(T2)

Measure method:

questionnaire

指标中文名:

术后行为量表评分

指标类型:

次要指标 

Outcome:

score of Post-Hospitalization Behavior Questionire

Type:

Secondary indicator 

测量时间点:

术后1周及术后1月

测量方法:

调查问卷

Measure time point of outcome:

one week and one month after surgery

Measure method:

questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

N/A

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 4 years
最大 Max age 6 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

由统计人员在EXCEL中,以随机函数(RAND)生成约220个随机数,均乘以2后进行四舍五入取整(FIXED),得1或2的随机数各约100个。参试患者顺序取随机数,为1者入试验组S组,为2者入对照组M组,个别为0的随机数弃之。

Randomization Procedure (please state who generates the random number sequence and by what method):

In the EXCEL, the statistician generates about 220 random numbers with a random function (RAND), multiplies by 2, and rounds off (FIXED), and obtains 1 or 2 random numbers of about 100 each.

盲法:

双盲

Blinding:

Double blind

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

EDC系统

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

EDC system

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

CRF

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

CRF

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-08-12
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