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音乐对微注水非麻醉肠镜的临床研究
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注册号:

Registration number:

ChiCTR1900027984 

最近更新日期:

Date of Last Refreshed on:

2019-12-07 

注册时间:

Date of Registration:

2019-12-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

音乐对微注水非麻醉肠镜的临床研究 

Public title:

Effects of music intervention in patients undergoing limited water-immersion colonoscopy without sedation: a pilot randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

音乐对微注水非麻醉肠镜的临床研究 

Scientific title:

Effects of music intervention in patients undergoing limited water-immersion colonoscopy without sedation: a pilot randomized controlled trial 

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:

傅丽霞 

研究负责人:

叶斌 

Applicant:

FU LIXIA 

Study leader:

YE BIN 

申请注册联系人电话:

Applicant telephone:

+86 13567618651 

研究负责人电话:

Study leader's telephone:

+86 13857078092 

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:

fulixials@163.com 

研究负责人电子邮件:

Study leader's E-mail:

408252097@qq.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:

浙江省丽水市莲都区括苍路289号 

研究负责人通讯地址:

浙江省丽水市莲都区括苍路289号 

Applicant address:

289 Kuocang Road, Liandu District, Lishui, Zhejiang, China 

Study leader's address:

289 Kuocang Road, Liandu District, Lishui, Zhejiang, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

浙江省丽水市中心医院消化内科 

Applicant's institution:

Division of Gastroenterology, Lishui Central Hospital 

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:

科研伦理(2019)第(120)号 

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:

丽水市中心医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Lishui Central Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-10-28 

伦理委员会联系人:

徐民 

Contact Name of the ethic committee:

XU MIN 

伦理委员会联系地址:

浙江省丽水市莲都区括苍路289号 

Contact Address of the ethic committee:

289 Kuocang Road, Liandu District, Lishui, Zhejiang, China  

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

浙江省丽水市中心医院 

Primary sponsor:

Lishui Central Hospital 

研究实施负责(组长)单位地址:

浙江省丽水市莲都区括苍路289号 

Primary sponsor's address:

289 Kuocang Road, Liandu District, Lishui, Zhejiang, China 

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):

Country:

China

Province:

Zhejiang

City:

单位(医院):

丽水市中心医院

具体地址:

浙江省丽水市莲都区括苍路289号

Institution
hospital:

Lishui Central Hospital

Address:

289 Kuocang Road, Liandu District, Lishui, Zhejiang, China

经费或物资来源:

单位提供经费 

Source(s) of funding:

unit funding 

研究疾病:

结直肠疾病 

Target disease:

Colorectal disease 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

治疗新技术临床试验 

Study phase:

New Treatment Measure Clinical Study 

研究目的:

比较音乐对微注水肠镜效果的影响,评估音乐对结肠镜检查患者疼痛、满意度、焦虑等的影响。 

Objectives of Study:

Evaluation of anxious, pain and patient satisfaction by music therapy in patients with limited water- immersion colonoscopy  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

(a)安排进行结肠镜检查的患者; (b)能够用中文交流; (c)结肠镜检查前血流动力学稳定。 

Inclusion criteria

1. Patients scheduled for colonoscopy; 2. Able to communicate in Chinese; 3. Hemodynamic stability before colonoscopy. 

排除标准:

视力和听觉有障碍,或有痴呆、认知障碍或精神病史患者,消化道出血、肠梗阻、严重炎症性肠病患者被排除在外。 

Exclusion criteria:

Patients with vision and hearing impairments, or with a history of dementia, cognitive impairment, or mental illness, were excluded from gastrointestinal bleeding, intestinal obstruction, and severe inflammatory bowel disease. 

研究实施时间:

Study execute time:

From2019-12-10To 2020-06-30 

干预措施:

Interventions:

组别:

1组

样本量:

100

Group:

Group 1

Sample size:

干预措施:

听音乐

干预措施代码:

Intervention:

listen music

Intervention code:

组别:

2组

样本量:

100

Group:

Group 2

Sample size:

干预措施:

不听音乐

干预措施代码:

Intervention:

no listen music

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):

 

Country:

China 

Province:

Zhejiang 

City:

 

单位(医院):

浙江省丽水市中心医院 

单位级别:

三级甲等医院 

Institution
hospital:

Lishui Central Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

焦虑

指标类型:

主要指标 

Outcome:

anxious

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

主要指标 

Outcome:

satisfaction

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

疼痛

指标类型:

主要指标 

Outcome:

pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

再次肠镜检查意愿

指标类型:

主要指标 

Outcome:

Willing for colonoscopy again

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

结直肠腺瘤发现率

指标类型:

主要指标 

Outcome:

Colorectal adenoma detection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

达盲率

指标类型:

主要指标 

Outcome:

Cecum arrival rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

活检标本

组织:

结直肠

Sample Name:

Biopsy specimen

Tissue:

Colorectal

人体标本去向

使用后保存 

说明

病理制片

Fate of sample:

Preservation after use 

Note:

Pathology

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 18 years
最大 Max age 70 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):

通过抽签将患者随机分为音乐治疗组或对照组。

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

Patients were randomized to music treatment or control groups by drawing of lots.

盲法:

Not used

Blinding:

Not used

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

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):

http://www.medresman.org.cn

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

http://www.medresman.org.cn

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:

一:原始数据记录在病例记录表中 二:原始数据上传至在ResMan

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

1: Raw data is recorded in the case record form 2: Raw data is uploaded to ResMan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-12-07
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