ChiCTR2000034145 版本V1.1 版本创建时间2020/06/26 09:50:53 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000034145 

最近更新日期：

Date of Last Refreshed on：

 2020-06-26 09:46:49 

注册时间：

Date of Registration：

 2020-06-26 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Assessing the effectiveness of animal therapy on alleviation of anxiety in pre-school children

Public title：

Assessing the effectiveness of animal therapy on alleviation of anxiety in pre-school children

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Assessing the effectiveness of animal therapy on alleviation of anxiety

Scientific title：

Assessing the effectiveness of animal therapy on alleviation of anxiety

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：

Mohammad Tahan 

研究负责人：

Mohammad Tahan 

Applicant：

Mohammad Tahan 

Study leader：

Mohammad Tahan 

申请注册联系人电话：

Applicant telephone：

 +989363049935

研究负责人电话：

Study leader's
telephone：

+989363049935

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：

 t.mohammad2@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 t.mohammad2@gmail.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：

no 4, atar 7, Khorasan, Iran

研究负责人通讯地址：

no 4, atar 7, Khorasan, Iran

Applicant address：

no 4, atar 7, Khorasan, Iran

Study leader's address：

no 4, atar 7, Khorasan, Iran

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：

伊朗伊斯兰阿扎德大学

Applicant's institution：

Islamic Azad University, Iran

研究负责人所在单位：

伊朗伊斯兰阿扎德大学

Affiliation of the Leader：

Islamic Azad University, Iran

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：

 0128/1398

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：

Institutional Review Board of Omid and Neshat Institute of Tehran

Name of the ethic committee：

Institutional Review Board of Omid and Neshat Institute of Tehran

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-04-04 00:00:00

伦理委员会联系人：

Azam Sadeghifar

Contact Name of the ethic committee：

Azam Sadeghifar

伦理委员会联系地址：

Institute Omid and Neshat, Tehran, Iran

Contact Address of the ethic committee：

Institute Omid and Neshat, Tehran, Iran

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：

Omid and Neshat Institute of Tehran

Primary sponsor：

Omid and Neshat Institute of Tehran

研究实施负责（组长）单位地址：

Institute Omid and Neshat, Tehran, Iran

Primary sponsor's address：

Institute Omid and Neshat, Tehran, Iran

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

伊朗

省(直辖市)：

德黑兰

市(区县)：

Country：

Iran

Province：

Tehran

City：

单位(医院)：

Omid and Neshat

具体地址：

Institute Omid and Neshat, Tehran, Iran

Institution
hospital：

Omid and Neshat

Address：

Institute Omid and Neshat, Tehran, Iran

经费或物资来源：

Institute Omid and Neshat

Source(s) of funding：

Institute Omid and Neshat

研究疾病：

焦虑症  

Target disease：

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：

 回顾性研究 

Study phase：

Retrospective study

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

The purpose of this study was to assess the effectiveness of animal therapy in alleviation of anxiety in pre-school children  

Objectives of Study：

The purpose of this study was to assess the effectiveness of animal therapy in alleviation of anxiety in pre-school children

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria were anxiety score above the average score, no psychological disorder, no physical disorder, tendency to participant in the study, and age range of 5-7 years

Inclusion criteria

Inclusion criteria were anxiety score above the average score, no psychological disorder, no physical disorder, tendency to participant in the study, and age range of 5-7 years

排除标准：

Failure to cooperate in research

Exclusion criteria：

Failure to cooperate in research

研究实施时间：

Study execute time：

从 From 2019-04-20 00:00:00至 To 2019-06-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-04-01 00:00:00 至 To 2019-05-10 00:00:00

干预措施：

Interventions：

组别：

Experimental group

样本量：

 10

Group：

Experimental group

Sample size：

干预措施：

animal therapy

干预措施代码：

Intervention：

animal therapy

Intervention code：

组别：

Control group

样本量：

 10

Group：

Control group

Sample size：

干预措施：

No treatment

干预措施代码：

Intervention：

No treatment

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 伊朗

省(直辖市)：

 德黑兰 

市(区县)：

  

Country：

Iran

Province：

Tehran

City：

单位(医院)：

 Omid and Neshat 

单位级别：

  

Institution
hospital：

Omid and Neshat

Level of the institution：

测量指标：

Outcomes：

指标中文名：

Spence Children Anxiety Scale for parents (SCAS-P):

指标类型：

主要指标

Outcome：

Spence Children Anxiety Scale for parents (SCAS-P):

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：

组织：

Sample Name：

questionnaire

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

-

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 5 岁 years
最大 Max age 7 岁 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）：

The study population consisted of all children at the age of 5 to 7 years with anxiety (referred by Tehran Welfare Anxiety Screening Program to Consultation Center; n=32). Totally, 20 children with an anxiety score higher than the average score were selected using convenient sampling.

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

The study population consisted of all children at the age of 5 to 7 years with anxiety (referred by Tehran Welfare Anxiety Screening Program to Consultation Center; n=32). Totally, 20 children with an anxiety score higher than the average score were selected using convenient sampling.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

是否共享原始数据：

IPD sharing

否No

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）：

NA

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

No later than 1 years after the randomization of the last participant, we will deliver a completely de-identified data through chictr

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：

After securing a letter or permission from the head of Tehran City Iranian Consultation Center and creating a good relationship with the parents of children with anxiety (referred to the center by Mashhad City Welfare Org.; n = 32), the parents who were interested in participation in the study were asked to sign a written letter of consent for their child’s participation in the study. The participants were ensured that their personal and private information will remain confidential and that the study is in compliance with religious and cultural codes. Afterwards, the parents filled out SCAS-P and participated in a structured interview based on DSM-V (pre-test). Then, 20 children with anxiety score above the average were selected through convenient sampling method and randomly assigned to experiment and control groups (each with 10 members). The experiment group received eight AAT sessions (each 90 min) and afterwards, the participants filled out the questionnaire once more (post-test).

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

After securing a letter or permission from the head of Tehran City Iranian Consultation Center and creating a good relationship with the parents of children with anxiety (referred to the center by Mashhad City Welfare Org.; n = 32), the parents who were interested in participation in the study were asked to sign a written letter of consent for their child’s participation in the study. The participants were ensured that their personal and private information will remain confidential and that the study is in compliance with religious and cultural codes. Afterwards, the parents filled out SCAS-P and participated in a structured interview based on DSM-V (pre-test). Then, 20 children with anxiety score above the average were selected through convenient sampling method and randomly assigned to experiment and control groups (each with 10 members). The experiment group received eight AAT sessions (each 90 min) and afterwards, the participants filled out the questionnaire once more (post-test).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2020-06-26 09:30:33