中医五音疗法治疗全面性发育迟缓患儿的临床研究

注册号:

Registration number:

ITMCTR2024000019

最近更新日期:

Date of Last Refreshed on:

2024-02-18

注册时间:

Date of Registration:

2024-02-18

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

中医五音疗法治疗全面性发育迟缓患儿的临床研究

Public title:

Clinical Study on Traditional Chinese Medicine Five-Tone Therapy for Children with Comprehensive Developmental Delay

注册题目简写:

English Acronym:

研究课题的正式科学名称:

中医五音疗法治疗全面性发育迟缓患儿的临床研究

Scientific title:

Clinical Study on Traditional Chinese Medicine Five-Tone Therapy for Children with Comprehensive Developmental Delay

研究课题的正式科学名称简写:

Scientific title acronym:

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:

刘瑶

研究负责人:

林法财

Applicant:

Liu Yao

Study leader:

Lin Fa Cai

申请注册联系人电话:

Applicant telephone:

13836961400

研究负责人电话:

Study leader's telephone:

18260087532

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:

liuyao_violette@163.com

研究负责人电子邮件:

Study leader's E-mail:

facai_lin@njucm.edu.cn

申请单位网址(自愿提供):

Study leader's 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:

中国江苏省南京市栖霞区仙林大道138号南京中医药大学

研究负责人通讯地址:

中国江苏省南京市栖霞区仙林大道138号南京中医药大学

Applicant address:

Nanjing University of Chinese Medicine, 138 Xianlin Avenue, Qixia District, Nanjing, Jiangsu Province, China

Study leader's address:

Nanjing University of Chinese Medicine, 138 Xianlin Avenue, Qixia District, Nanjing, Jiangsu Province, 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:

南京中医药大学

Applicant's institution:

Nanjing University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2023-202-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

郑州大学第三附属医院伦理委员会

Name of the ethic committee:

Ethics Committee of the Third Affiliated Hospital of Zhengzhou University

伦理委员会批准日期:

Date of approved by ethic committee:

2023/8/23 0:00:00

伦理委员会联系人:

王培

Contact Name of the ethic committee:

Wang Pei

伦理委员会联系地址:

河南省郑州市二七区康复前街7号

Contact Address of the ethic committee:

No.7 Rehabilitation Front Street, Erqi District, Zhengzhou City, Henan Province, China

伦理委员会联系人电话:

Contact phone of the ethic committee:

0371-66903091

伦理委员会联系人邮箱:

Contact email of the ethic committee:

zdsfyll1@163.com

研究实施负责(组长)单位:

郑州大学第三附属医院

Primary sponsor:

The Third Affiliated Hospital of Zhengzhou University

研究实施负责(组长)单位地址:

河南省郑州市二七区康复前街7号

Primary sponsor's address:

No.7 Rehabilitation Front Street, Erqi District, Zhengzhou City, Henan Province, 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):

河南

市(区县):

郑州

Country:

China

Province:

Henan

City:

单位(医院):

郑州大学第三附属医院

具体地址:

河南省郑州市二七区康复前街7号

Institution
hospital:

The Third Affiliated Hospital of Zhengzhou University

Address:

No.7 Rehabilitation Front Street, Erqi District, Zhengzhou City, Henan Province, China

经费或物资来源:

Source(s) of funding:

None

研究疾病:

全面性发育迟缓

研究疾病代码:

Target disease:

global developmental delay,GDD

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究在康复治疗的基础上给予 GDD 患儿中医五行音乐治疗,分析中医五行音乐治疗前后对 GDD 患儿神经行为发育的影响,为 GDD 的治疗寻找安全有效的方法。

Objectives of Study:

This study provides Traditional Chinese Medicine Five-Element music therapy to children with Growth and Developmental Delay (GDD) on the basis of rehabilitation treatment. The analysis assesses the impact of Traditional Chinese Medicine Five-Element music therapy on the neurobehavioral development of children with GDD before and after treatment, aiming to explore safe and effective methods for the treatment of GDD.

药物成份或治疗方案详述:

60符合条件的 GDD 患儿随机分为2组,对照组和治疗组,每组30例。 对照组:常规治疗,患儿进行综合康复训练,包括:引导式教育、语言训练、感觉统合训练、作业疗法、情景互动、经颅磁刺激治疗等。 治疗组:五行音乐结合常规治疗,每次播放音乐30min。 以上治疗均为每周1至周五每日1次,周六周日休息2天,4周为1个疗程,疗程结束后休息1周,共3个疗程。 怒:生气,角调乐曲--《草木青青》、《江南好》、《胡笳十八拍》、《江南竹丝乐》 喜:开心、笑,徵调乐曲--《喜相逢》、《步步高》、《喜洋洋》、《百鸟朝凤》 思:想念、思虑,宫调乐曲--《梅花三弄》、《平湖秋月》、《月儿高》、《春江花月夜》 悲:悲伤、难过,商调乐曲--《阳关三叠》、《潇乡水云》、《嘎达梅林》、《将军令》 恐:害怕,羽调乐曲--《汉宫秋月》、《二泉映月》、《平沙落雁》、《塞上曲》

Description for medicine or protocol of treatment in detail:

60 eligible children with GDD were randomly divided into 2 groups, the control group and the treatment group, with 30 cases in each group. Control group: conventional treatment, children with comprehensive rehabilitation training, including: guided education, language training, sensory integration training, occupational therapy, situational interaction, transcranial magnetic stimulation therapy. Treatment group: five elements of music combined with conventional treatment, playing music for 30 min each time. All of the above treatments are once a day from 1 to Friday every week, with 2 days of rest on Saturday and Sunday,4weeks for 1 course of treatment, and 1 week of rest at the end of the course, for a total of 3 courses of treatment. Anger: anger, angular tone music - "The Grass is Green", "Jiangnan is Good", "Eighteen Beats of Hu Jia", "Jiangnan Bamboo Silk Music". Joy: happy, laughing, music in the tone of Zheng - "Joyful Encounter", "Step by Step", "Joyful", "Birds of a Feather". Thoughts: Missing, thinking, Gong mode music - "Three Melodies of Plum Blossoms", "Autumn Moon on the Pinghu Lake", "The Moon is High", "Moonlit Night on the Spring River". Sorrow: sadness, sadness, music in Shang mode - "Yangguan Sanyi", "Xiaoxiang Shuiyun", "Gada Meilin", "General's Order". Fear: Fearful, Feather Tone Music - "Autumn Moon in the Han Palace", "Reflecting the Moon in Two Springs", "Flat Sand and Falling Geese", "Song on the Plateau".

纳入标准:

①年龄1~5岁,性别不限; ②符合《精神障碍诊断与统计手册》第5版(DSM-Ⅴ)中 GDD 的诊断标准 ③Gesell 发育诊断量表发育商数25~75 ⑤患儿家属知情同意。

Inclusion criteria

1. Age 1 to 5 years old, any gender. 2. Meet the diagnostic criteria for GDD in the fifth edition of the "Diagnostic and Statistical Manual of Mental Disorders" (DSM-5). 3. Gesell Developmental Diagnosis Scale developmental quotient between 25 and 75. 4. Informed consent from the family members of the child.

排除标准:

①其他任何可导致脑功能紊乱的严重躯体或精神疾患 ②明确头颅外伤史 ③入组前1个月内曾服用可导致认知功能损害药物者 ④合并癫痫者

Exclusion criteria:

1. Any other severe physical or mental disorders that may cause disruption of brain function. 2. Documented history of head injury. 3. Use of drugs causing cognitive impairment within the month prior to enrollment. 4. Presence of epilepsy.

研究实施时间:

Study execute time:

From 2024-02-01

To      2024-04-30

征募观察对象时间:

Recruiting time:

From 2023-09-01

To      2024-01-31

干预措施:

Interventions:

组别:

治疗组

样本量:

30

Group:

Treatment Group

Sample size:

干预措施:

五行音乐结合常规治疗,每次播放音乐30min

干预措施代码:

Intervention:

Five Elements Music combined with regular therapy, playing music for 30mi at a time

Intervention code:

组别:

对照组

样本量:

30

Group:

Control Group

Sample size:

干预措施:

常规治疗,患儿进行综合康复训练,包括:引导式教育、语言训练、感觉统合训练、作业疗法、情景互动、经颅磁刺激治疗等

干预措施代码:

Intervention:

Conventional treatment, children with comprehensive rehabilitation training, including: guided education, language training, sensory integration training, occupational therapy, situational interaction, transcranial magnetic stimulation therapy, etc.

Intervention code:

样本总量 Total sample size : 60

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

河南省

市(区县):

郑州市

Country:

中国

Province:

Henan

City:

Zhengzhou

单位(医院):

郑州大学第三附属医院

单位级别:

三级甲等

Institution/hospital:

The Third Affiliated Hospital of Zhengzhou University

Level of the institution:

Grade 3A hospital

测量指标:

Outcomes:

指标中文名:

中国幼儿情绪性及社会性发展量表

指标类型:

主要指标

Outcome:

CITSEA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Achenbach 儿童行为量表(CBCL)评估

指标类型:

主要指标

Outcome:

Achenbach Child Behavior Scale (CBCL) Assessment

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

婴儿--初中学生的社会生活能力量表

指标类型:

主要指标

Outcome:

infant-junior middle school students' social-Life abilities scale

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

格赛尔发育量表

指标类型:

主要指标

Outcome:

Gesell Developmental Diagnostic Scale

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:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 1
Min age years
最大 5
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

由研究团队专人进行随机分组,采用随机数字表法,计算机生成随机数字。 操作步骤: (1)编号:60例患者按照就诊顺序进行编号; (2)获取随机数字:从随机数字表中任意一个数开始,沿同一方向顺序获取每例患者一个随机数字; (3)求余数:随机数除以2求余数 (4)分组:按余数分组,1为对照组,0为治疗组

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

Randomized grouping was performed by the research team's dedicated staff, and computer-generated random numbers were used using the random number table method. -Operational Steps: (1) Numbering:60cases of patients are numbered in the order of consultation (2) Obtaining random numbers: Starting from any number in the random number table, obtain a random number for each case of patients in the same direction and order (3) Find the remainder: the random number divided by 2 to find the remainder (4) Grouping: group by remainder,1for control group,0for treatment group

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

Yes

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):

ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

ResMan Clinical Trial Public Management Platform “http://www.medresman.org.cn/uc/index.aspx”

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、病例记录表 二、电子采集和管理系统:ResMan临床试验公共管理平台“http://www.medresman.org.cn/uc/index.aspx”

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

1.Case Record Form, CRF 2.Electronic Data Capture, EDC,ResMan Clinical Trial Public Management Platform “http://www.medresman.org.cn/uc/index.aspx”

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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