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A Study on the Effects and Mechanisms of Multi-sensory Stimulation Care on Patients with Insomnia of Heart-Spleen Deficiency Type

注册号：

Registration number：

ITMCTR2025001077

最近更新日期：

Date of Last Refreshed on：

2025-05-29

注册时间：

Date of Registration：

2025-05-29

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

多感官刺激调护对心脾两虚型失眠患者的影响及作用效应研究

Public title：

A Study on the Effects and Mechanisms of Multi-sensory Stimulation Care on Patients with Insomnia of Heart-Spleen Deficiency Type

注册题目简写：

English Acronym：

研究课题的正式科学名称：

多感官刺激调护对心脾两虚型失眠患者的影响及作用效应研究

Scientific title：

A Study on the Effects and Mechanisms of Multi-sensory Stimulation Care on Patients with Insomnia of Heart-Spleen Deficiency Type

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：

曲子涵

研究负责人：

张红石

Applicant：

Qu Zihan

Study leader：

Zhang Hongshi

申请注册联系人电话：

Applicant telephone：

+86 155 5434 3235

研究负责人电话：

Study leader's telephone：

+86 139 4301 8168

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：

2507458157@qq.com

研究负责人电子邮件：

Study leader's E-mail：

5503576@qq.com

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：

吉林省长春市净月国家高新技术产业开发区净月街道博硕路1035号

研究负责人通讯地址：

吉林省长春市净月国家高新技术产业开发区净月街道博硕路1035号

Applicant address：

No. 1035 Boshuo Road Jingyue Sub-district Jingyue National High-tech Industrial Development Zone Changchun City Jilin Province

Study leader's address：

No. 1035 Boshuo Road Jingyue Sub-district Jingyue National High-tech Industrial Development Zone Changchun City Jilin Province

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：

长春中医药大学

Applicant's institution：

Changchun 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：

CZDSFYLL2025-021-01

伦理委员会批件附件：

Approved file of Ethical Committee：

View

批准本研究的伦理委员会名称：

长春中医药大学附属第三临床医院医学伦理委员会

Name of the ethic committee：

The Medical Ethics Committee of the Third Clinical Hospital Affiliated to Changchun University of Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

2025/2/24 0:00:00

伦理委员会联系人：

遇准

Contact Name of the ethic committee：

Yu Zhun

伦理委员会联系地址：

吉林省长春市长春净月高新技术产业开发区净月大街1643号

Contact Address of the ethic committee：

No.1643 Jingyue Street Jingyue Hi-Tech Industrial Development Zone Changchun Jilin China

伦理委员会联系人电话：

Contact phone of the ethic committee：

0431-89912033

伦理委员会联系人邮箱：

Contact email of the ethic committee：

czdsfy112020@163.com

研究实施负责（组长）单位：

长春中医药大学附属第三临床医院

Primary sponsor：

The Third Clinical Hospital of Changchun University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

吉林省长春市长春净月高新技术产业开发区净月大街1643号

Primary sponsor's address：

No.1643 Jingyue Street Jingyue Hi-Tech Industrial Development Zone Changchun Jilin 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)：

吉林省

市(区县)：

长春市

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

长春中医药大学附属第三临床医院

具体地址：

吉林省长春市长春净月高新技术产业开发区净月大街1643号

Institution
hospital：

The Third Clinical Hospital of Changchun University of Traditional Chinese Medicine

Address：

No.1643 Jingyue Street Jingyue Hi-Tech Industrial Development Zone Changchun Jilin China

经费或物资来源：

国家自然科学基金(面上项目)(82074569)

Source(s) of funding：

National Natural Science Foundation of China (General Program)(82074569)

研究疾病：

失眠

研究疾病代码：

Target disease：

insomnia

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：

其它

Others

研究目的：

本研究通过开展临床试验，给予心脾两虚型患者多感官刺激调护干预，使用匹兹堡睡眠质量指数、失眠严重程度指数量表、多导睡眠监测等主客观指标评价，旨在观察和评价多感官刺激疗法对失眠患者睡眠质量的改善情况。

Objectives of Study：

In this study through conducting clinical trials multi-sensory stimulation care intervention was given to patients with deficiency of both heart and spleen. Subjective and objective indicators such as the Pittsburgh Sleep Quality Index Insomnia Severity Index Scale and polysomnography were used for evaluation. The aim was to observe and evaluate the improvement of sleep quality in patients with insomnia by multi-sensory stimulation therapy.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

1.符合上述对中西医心脾两虚型失眠的诊断标准。 2.50周岁≤年龄≤65周岁。 3.未使用精神类药物或停药2周以上。 4.签署知情同意书，自愿参加本项研究者。 5.匹兹堡睡眠指数(PSQI)≥7分。 6.听力、嗅觉正常，之前一年内患者没有接受过音乐治疗和芳香疗法。

Inclusion criteria

1.It meets the above diagnostic criteria for insomnia caused by deficiency of both heart and spleen in both traditional Chinese and Western medicine. 2.50 years old ≤ Age ≤65 years old. 3. No psychotropic drugs have been used or the medication has been discontinued for more than two weeks. 4. Sign the informed consent form and voluntarily participate in this research. 5. Pittsburgh Sleep Index (PSQI)≥7 points. 6. The patient's hearing and sense of smell are normal. The patient has not received music therapy or aromatherapy within the previous year.

排除标准：

1.有严重内脏器质性疾病（如心、脑血管疾病）或肿瘤患者合并感染和出血等严重消耗性疾病者。 2.因疼痛、发热、咳嗽、手术等全身性疾病，以及外界环境干扰因素引起失眠者。 3.近期有重大心理创伤和精神性疾病患者。 4.患有呼吸相关的睡眠障碍，昼夜节律睡眠障碍和睡眠机能紊乱者。 5.治疗部位皮肤有感染或皮肤为超敏皮肤者。 6.对本研究选用的精油过敏、嗅觉障碍或有过敏病史和严重过敏体质者。

Exclusion criteria：

1.Patients with severe organic internal organ diseases (such as cardiovascular and cerebrovascular diseases) or tumors complicated with severe consumptive diseases such as infection and bleeding. 2. Those who suffer from insomnia due to systemic diseases such as pain fever cough and surgery as well as external environmental interference factors. 3. Patients who have recently suffered from major psychological trauma or mental disorders. 4. People suffering from breathing-related sleep disorders circadian rhythm sleep disorders and sleep dysfunction. 5. Those with skin infection at the treatment site or hypersensitive skin. 6. Those who are allergic to the essential oils selected for this study have olfactory disorders or have a history of allergies and a severe allergic constitution.

研究实施时间：

Study execute time：

从From 2025-02-25

至To      2025-12-31

征募观察对象时间：

Recruiting time：

从From 2025-02-25

至To      2025-12-31

干预措施：

Interventions：

组别：

对照组

样本量：

32

Group：

Control group

Sample size：

干预措施：

实施单感官刺激调护：触觉刺激（腹部推拿），每日1次，30min/次，5天为1个疗程，每个疗程间隔2天，治疗4个疗程，治疗结束后第4周，进行随访1次。

干预措施代码：

Intervention：

Implement single-sensory stimulation care: tactile stimulation (abdominal massage) once a day 30 minutes each time 5 days as one course of treatment with a 2-day interval between each course of treatment. Four courses of treatment were carried out. In the fourth week after the end of the treatment a follow-up was conducted once.

Intervention code：

组别：

试验组

样本量：

32

Group：

Experimental group

Sample size：

干预措施：

实施多感官刺激调护：触觉刺激（腹部推拿）+听觉刺激（五音调护）+嗅觉刺激（中药芳香疗法），每日1次，30min/次，5天为1个疗程，每个疗程间隔2天，治疗4个疗程，治疗结束后第4周，进行随访1次。

干预措施代码：

Intervention：

Implement multi-sensory stimulation care: tactile stimulation (abdominal massage) + auditory stimulation (five-tone care) + olfactory stimulation (traditional Chinese medicine aromatherapy), once a day, 30 minutes each time, 5 days as one course of treatment, with a 2-day interval between each course of treatment. Four courses of treatment were carried out. In the fourth week after the end of the treatment, a follow-up was conducted once.

Intervention code：

样本总量 Total sample size ： 64

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

吉林省

市(区县)：

长春市

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

长春中医药大学附属第三临床医院

单位级别：

三级，三甲

Institution/hospital：

The Third Clinical Hospital Affiliated to Changchun University of Chinese Medicine

Level of the institution：

Tertiary Tertiary A

测量指标：

Outcomes：

指标中文名：

疲劳量表-14

指标类型：

次要指标

Outcome：

Fatigue Scale-14

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

抑郁自评量表

指标类型：

次要指标

Outcome：

Self-rating Depression Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

阿森斯失眠量表

指标类型：

次要指标

Outcome：

Athens Insomnia Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

多导睡眠监测

指标类型：

主要指标

Outcome：

Plysomnography

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

中医证候积分量表

指标类型：

次要指标

Outcome：

Scoring of the TCM Syndrome Score Scale

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

匹兹堡睡眠质量指数

指标类型：

主要指标

Outcome：

Pittsburgh Sleep Quality Index

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

焦虑自评量表

指标类型：

次要指标

Outcome：

Self-rating Anxiety Scale

Type：

Secondary 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：

无

组织：

Sample Name：

None

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

正在进行

Recruiting

年龄范围：

最小 50 岁
Min age years
最大 65 岁
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）：

所有64例患者均来源于长春中医药大学附属第三临床医院睡眠障碍门诊，查阅随机数字表，得到64个随机数字，准备64个信封，制作随机卡，按1-64编号，随机卡上注明卡号、随机数字、组别并放入。填好随机卡将其装入对应编号的信封袋封存，纳入病例时，按就诊顺序打开信封，按分配方案入组。共分为两组：试验组，对照组，每组32例患者。

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

All 64 patients were from the Sleep Disorder Clinic of the Third Clinical Hospital Affiliated to Changchun University of Chinese Medicine. The random number table was consulted to obtain 64 random numbers. 64 envelopes were prepared and random cards were made. They were numbered from 1 to 64. The card number random number and group were noted on the random card and placed inside. Fill in the random card and put it into the envelope bag with the corresponding number for sealing. When including cases open the envelope in the order of visit and enroll according to the allocation plan. It was divided into two groups: the experimental group and the control group with 32 patients in each group.

盲法：

本研究评估者和受试者均对分组情况不知情，以减少主观因素对结果的影响。结果评估由一个不参与研究实施的独立结果评估小组来评估结果，该小组由2名具有丰富临床经验的医生和2名经过专业培训的研究助理组成，2名医生负责分析与整理多导睡眠监测记录仪的数据，2名研究助理负责收集和整理受试者的主观评估问卷。此外，负责数据分析的研究者将尽可能对受试者分配不知情。

Blinding：

In this study neither the evaluators nor the subjects were informed of the grouping situation in order to reduce the influence of subjective factors on the results. The results were evaluated by an independent results evaluation team that was not involved in the implementation of the study. The team consisted of two doctors with rich clinical experience and two professionally trained research assistants. The two doctors were responsible for analyzing and organizing the data from the polysomnography recorder and the two research assistants were responsible for collecting and organizing the subjective assessment questionnaires of the subjects. Furthermore the researchers responsible for data analysis will be as unaware of the assignment of subjects as possible.

是否共享原始数据：

IPD sharing：

是

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）：

2035.01.01 2507458157@qq.com

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

2035.01.01 2507458157@qq.com

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：

数据采集主要由多导睡眠监测仪和自制病例记录表采集，多导睡眠监测分别在干预前后采集，自制病例记录表包括一般资料调查表、焦虑自评量表、抑郁自评量表、匹兹堡睡眠质量指数量表、阿森斯失眠量表、中医证候积分量表，一般资料调查表、焦虑自评量表、抑郁自评量表在干预前评估，匹兹堡睡眠质量指数量表、阿森斯失眠量表、中医证候积分量表分别在干预前、干预后和随访时进行评估。

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

Data collection was mainly conducted by polysomnosy monitors and self-made case record sheets. Polysomnosy monitoring was collected before and after the intervention respectively. The self-made case record sheets included the General Information Questionnaire the Self-Rating Anxiety Scale the Self-Rating Depression Scale the Pittsburgh Sleep Quality Index Scale the Adams-Insomnia Scale and the Traditional Chinese Medicine Syndrome Score Scale. The General information questionnaire the Self-Rating Anxiety Scale and the Self-Rating Depression Scale were evaluated before the intervention. The Pittsburgh Sleep Quality Index Scale the Arthas Insomnia Scale and the TCM Syndrome Score Scale were evaluated before the intervention after the intervention and during the follow-up respectively.

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

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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