Observation on curative effect of auricular acupoint pressing combined with rehabilitation training on sleep disorder of preschool children with autism

Registration number:

ITMCTR2100005015

Date of Last Refreshed on:

2021-07-05

Date of Registration:

2021-07-05

Registration Status:

Prospective registration

Public title:

Observation on curative effect of auricular acupoint pressing combined with rehabilitation training on sleep disorder of preschool children with autism

English Acronym:

Scientific title:

Observation on curative effect of auricular acupoint pressing combined with rehabilitation training on sleep disorder of preschool children with autism

Scientific title acronym:

Study subject ID:

The registration number of the Partner Registry or other register:

ChiCTR2100048257 ; ChiMCTR2100005015

Applicant:

Duan Duoxi

Study leader:

Li Tao

Applicant telephone:

+86 18202877671

Study leader's telephone:

+86 13688160885

Applicant Fax:

Study leader's fax:

Applicant E-mail:

412186834@qq.com

Study leader's E-mail:

15684767@qq.com

Study leader's website(voluntary supply):

Study leader's website
(voluntary supply):

Applicant address:

4 Fourth Section of Erhuan Road North, Chenghua District, Chengdu, Sichuan

Study leader's address:

4 Fourth Section of Erhuan Road North, Chenghua District, Chengdu, Sichuan

Applicant postcode:

Study leader's postcode:

Applicant's institution:

Nuclear Industry 416th Hospital

Approved by ethic committee:

Approved No. of ethic committee:

KJ2021012

Approved file of Ethical Committee:

View

Name of the ethic committee:

The Ethics Committee of Nuclear Industry 416th Hospital

Date of approved by ethic committee:

2021/2/22 0:00:00

Contact Name of the ethic committee:

Zhu Jun

Contact Address of the ethic committee:

4 Fourth Section of Erhuan Road North, Chenghua District, Chengdu, Sichuan

Contact phone of the ethic committee:

Contact email of the ethic committee:

Primary sponsor:

Nuclear Industry 416th Hospital

Primary sponsor's address:

4 Fourth Section of Erhuan Road North, Chenghua District, Chengdu, Sichuan

Secondary sponsor:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution
hospital:

Nuclear Industry 416th Hospital

Address:

4 Fourth Section of Erhuan Road North, Chenghua District

Source(s) of funding:

Nuclear Industry 416th Hospital

Target disease:

sleep disorder

Target disease code:

Study type:

Interventional study

Study design:

randomized controlled trial(parallel group design)

Study phase:

Others

Objectives of Study:

In this study, by observing the clinical efficacy of auricular point sticking combined with conventional rehabilitation therapy on children with insomnia disorder, the therapeutic mechanism of the therapy was discussed.

Description for medicine or protocol of treatment in detail:

Inclusion criteria

1. Meet the diagnostic criteria for autism and sleep disorders at the same time; 2. The age range is between 2 and 6 years old; 3. Those who did not take targeted treatment measures within one week before the selection; 4. Accompanied by parents or family members, signed the informed consent and can cooperate to complete the relevant scales; 5. Those who are willing to accept the treatment plan.

Exclusion criteria:

1. Patients with serious cardiovascular and cerebrovascular, liver, kidney, blood and other system diseases; 2. Other diseases: mainly Asperger syndrome, heller syndrome (child disintegrating psychosis, also known as infant dementia), Retts syndrome, specific receptive language disorder, childhood schizophrenia ; 3. Patients who do not agree to cooperate with clinical research due to tactile sensitivity or other reasons.

Study execute time:

From 2021-09-01

To      2023-05-15

Recruiting time:

From 2021-09-01

To      2022-10-31

Interventions:

22

Group:

control group

Sample size:

Intervention:

conventional rehabilitation

Intervention code:

22

Group:

experimental group

Sample size:

Intervention:

auricular acupoint pressing

Intervention code:

Total sample size : 44

Countries of recruitment
and research settings:

Country:

China

Province:

Sichuan

City:

Chengdu

Institution/hospital:

Nuclear Industry 416th Hospital

Level of the institution:

Tertiary A

Outcomes:

Outcome:

The Children's Sleep Habits Questionnaire,CSHQ

Type:

Primary indicator

Measure time point of outcome:

Measure method:

Questionnaires

Outcome:

Autism Behavior Checklist

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Outcome:

Sleep encephalogram

Type:

Secondary indicator

Measure time point of outcome:

Measure method:

Collecting sample(s)
from participants:

Sample Name:

Null

Tissue:

Fate of sample 

Others

Note:

Not yet recruiting

2
Min age years
6
Max age years

Recruiting status:

Participant age:

Gender:

Both

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

random number table

Blinding:

Not stated

IPD sharing:

Yes

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

private

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

managed by data management committee

Data Managemen Committee:

Yes

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

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above