ChiCTR2500102953 版本V1.0 版本创建时间2025/05/22 09:07:07 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：

 ChiCTR2500102953 

最近更新日期：

Date of Last Refreshed on：

 2025-05-22 09:06:48 

注册时间：

Date of Registration：

 2025-05-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

感觉意识集中训练对家属 ICU后综合征干预的效果研究:一项随机对照试验

Public title：

Study on the Effect of Sensation Awareness Focused Training on the Intervention of Post-ICU Syndrome of Family: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

感觉意识集中训练对家属 ICU后综合征干预的效果研究:一项随机对照试验

Scientific title：

Study on the Effect of Sensation Awareness Focused Training on the Intervention of Post-ICU Syndrome of Family: A 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：

李钦钦 

研究负责人：

姚丽 

Applicant：

Li Qinqin 

Study leader：

Yao Li 

申请注册联系人电话：

Applicant telephone：

 +86 152 8501 0791

研究负责人电话：

Study leader's
telephone：

+86 186 8512 5474

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：

 1394388776@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 liyao5452@126.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：

贵州省贵阳市贵安新区贵州医科大学(云漫湖校区)

研究负责人通讯地址：

贵州省贵阳市云岩区贵医街28号

Applicant address：

Guizhou Medical University (Yunmanhu Campus), GUI 'an New Area, Guiyang City, Guizhou Province

Study leader's address：

28Guiyi Street, Yunyan District, Guiyang City, Guizhou Province

申请注册联系人邮政编码：

Applicant postcode：

 550025

研究负责人邮政编码：

Study leader's postcode：

 550004

申请人所在单位：

贵州医科大学护理学院

Applicant's institution：

School of Nursing, Guizhou Medical University

研究负责人所在单位：

贵州医科大学附属医院呼吸与危重症医学科

Affiliation of the Leader：

Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Guizhou Medical University

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：

 2025伦审第(219)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：

贵州医科大学附属医院医学科学伦理委员会

Name of the ethic committee：

The Ethics Committee of the Affiliated Hospital of GuiZhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-23 00:00:00

伦理委员会联系人：

刘文

Contact Name of the ethic committee：

Liu Wen

伦理委员会联系地址：

贵州省贵阳市云岩区贵医街28号

Contact Address of the ethic committee：

28 Guiyi Street, Yunyan District, Guiyang City, Guizhou Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 851 8675 2685

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：

贵州医科大学附属医院

Primary sponsor：

Affiliated Hospital of Guizhou Medical University

研究实施负责（组长）单位地址：

贵州省贵阳市云岩区贵医街28号

Primary sponsor's address：

28 Guiyi Street, Yunyan District, Guiyang City, Guizhou Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

贵州省

市(区县)：

贵阳市

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

贵州医科大学附属医院

具体地址：

贵州省贵阳市云岩区贵医街28号

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Address：

28 Guiyi Street, Yunyan District, Guiyang City, Guizhou Province

经费或物资来源：

贵州省科学技术厅

Source(s) of funding：

Department of Science and Technology of Guizhou Province

研究疾病：

家属ICU后综合征  

Target disease：

Post-ICU Syndrome of Family (PICS-F)

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：

 治疗新技术临床试验 

Study phase：

New Treatment Measure Clinical Study

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

本研究计划通过随机对照试验来探讨在ICU 患者住院期间，对其家属进行感觉意识集中训练(Sensation Awareness Focused Training,SAF-T)，旨在探讨 SAF-T 对缓解家属压力以及预防家属ICU后综合征（Post-ICU Syndrome of Family，PICS-F）发生的有效性。通过这项研究，我们旨在将研究成果转化为实际应用，为家属 ICU 后综合征的干预提供科学依据和实践指导，从而为患者家属提供更全面的支持，  

Objectives of Study：

This research plan aims to explore Sensation Awareness Focused Training (SAF-T) for the family members of ICU patients during their hospitalization through a randomized controlled trial. The aim is to explore the effectiveness of SAF-T in alleviating the stress of family members and preventing the occurrence of post-ICU syndrome (PICS-F) in family members. Through this research, we aim to transform the research results into practical applications, providing scientific basis and practical guidance for the intervention of post-ICU syndrome in family members, thereby offering more comprehensive support to the families of patients.

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）患者入住ICU时间≥24小时； （2）患者家属（父母、子女、配偶、兄弟或姐妹）年龄≥18岁； （3）每位患者对应一名家属，该家属承担患者的主要照顾作用和医疗决策； （4）患者家属既往无精神病史或其它严重器质性疾病者； （5）患者家属知情同意，自愿参加本研究。

Inclusion criteria

(1) The patient's stay in the ICU is >=24 hours; (2) The age of the patient's family members (parents, children, spouse, brothers or sisters) is ≥18 years old; (3) Each patient corresponds to one family member, who is responsible for the main care and medical decision-making of the patient. (4) Family members of the patient have no history of mental illness or other serious organic diseases in the past; (5) The family members of the patients gave informed consent and voluntarily participated in this study.

排除标准：

(1)家属因自身原因拒绝参与本研究者; (2)有心理疾病或其他严重器质性疾病者; (3)严重听力、语言表达障碍不能配合完成研究者。

Exclusion criteria：

(1) Family members refuse to participate in this researcher due to their own reasons; (2) Those with mental disorders or other serious organic diseases; (3) Researchers with severe hearing and language expression impairments who are unable to cooperate in completing the research.

研究实施时间：

Study execute time：

从 From 2025-03-31 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-01 00:00:00 至 To 2025-08-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 28

Group：

Intervention group

Sample size：

干预措施：

ICU常规护理+感觉意识集中训练。SAF-T每次干预需要15-20分钟，由受过SAF-T训练的研究人员根据预先准备好的脚本对受试者进行指导，引导受试者意识到与ICU相关的负性生物压力感觉。研究人员面向受试者而坐，将手置于受试者视线范围内，进行重复快速平行滑动（由左向右，再由右向左；40次/分），幅度控制在90°以内。在此过程中，受试者保持头部静止，仅用眼睛跟踪研究人员的手指移动，并保持缓慢节律的深呼吸。

干预措施代码：

Intervention：

ICU routine care +SAF-T.Each SAF-T intervention lasted 15-20 minutes and was directed by SAF-T-trained researchers to make them aware of the negative biological stress sensations associated with the ICU according to a pre-prepared script. The researchers sat facing the subjects, placed their hands within the subjects' line of sight, and performed repeated rapid parallel sliding (from left to right, and then from right to left;) (40 times per minute), with the amplitude controlled within 90°. During this process, the subjects kept their heads still, tracked the movement of the researchers' fingers only with their eyes, and maintained slow and rhythmic deep breathing.

Intervention code：

组别：

对照组

样本量：

 28

Group：

Control group

Sample size：

干预措施：

ICU 患者住院期间，向家属简单介绍ICU 环境、设备和探视时间，与家属保持良好的沟通，及时传达患者的病情、治疗计划和进展，以及可能的并发症同时，向家属传授一些基本的护理知识和技巧,使家属能够在适当的时候参与患者的照顾,如协助患者进行康复训练、提供生活照顾等,以促进患者的康复进程必要时提供心理支持。出院时给予健康指导。出院后，通过门诊复诊、电话或微信群进行随访。

干预措施代码：

Intervention：

During the hospitalization of ICU patients, briefly introduce the ICU environment, equipment and visiting hours to the family members, maintain good communication with them, promptly convey the patient's condition, treatment plan and progress, as well as possible complications. At the same time, Impart some basic nursing knowledge and skills to the family members, enabling them to participate in the patient's care at appropriate times, such as assisting the patient in rehabilitation training, providing daily care, etc., to promote the patient's recovery process, and offer psychological support when necessary. Health guidance was given upon discharge. After discharge, follow-up visits will be conducted through outpatient follow-up, phone calls or wechat groups.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 贵州省 

市(区县)：

 贵阳市 

Country：

China

Province：

Guizhou

City：

Guiyang

单位(医院)：

 贵州医科大学附属医院 

单位级别：

 三甲医院 

Institution
hospital：

Affiliated Hospital of Guizhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

压力

指标类型：

主要指标

Outcome：

Pressure

Type：

Primary indicator

测量时间点：

入组第1、3、30、90天

测量方法：

感知压力量表

Measure time point of outcome：

The 1st, 3rd, 30th and 90th days of enrollment

Measure method：

Perceived Stress Scale,PSS

指标中文名：

焦虑

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

入组第1、3、30、90天

测量方法：

广泛性焦虑障碍量表

Measure time point of outcome：

The 1st, 3rd, 30th and 90th days of enrollment

Measure method：

7-time Generalized Anxiety Disorder Scale,GAD?7

指标中文名：

抑郁

指标类型：

主要指标

Outcome：

Depression

Type：

Primary indicator

测量时间点：

入组第1、3、30、90天

测量方法：

患者健康调查问卷

Measure time point of outcome：

The 1st, 3rd, 30th and 90th days of enrollment

Measure method：

Patient Health Questionnaire-9,PHO-9

指标中文名：

创伤后应激障碍

指标类型：

次要指标

Outcome：

Post-traumatic stress disorder

Type：

Secondary indicator

测量时间点：

入组第1、3、30、90天

测量方法：

事件影响量表修订版

Measure time point of outcome：

The 1st, 3rd, 30th and 90th days of enrollment

Measure method：

Impact ofEvent Scale-Revised,IES-R

指标中文名：

睡眠

指标类型：

次要指标

Outcome：

Sleep

Type：

Secondary indicator

测量时间点：

入组第1、3、30、90天

测量方法：

匹兹堡睡眠质量指数量表

Measure time point of outcome：

The 1st, 3rd, 30th and 90th days of enrollment

Measure method：

PittsburghSleep Quality Index,PSQI

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

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 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）：

首先对符合入选标准并最终进入干预的研究对象进行编号，由非课题组成员运用 Research Randomizer 随机化软件(randomizer.org)产生1套随机数字序列，该随机数字序列包含个 56 不重复的数字，范围为1-56。

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

First, eligible participants who meet the inclusion criteria and are finally enrolled in the intervention are assigned sequential numbers. A non-study team member uses the Research Randomizer software (randomizer.org) to generate a single set of 56 unique random numbers within the range of 1–56.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

因为本研究为面对面的干预，无法对干预者和研究对象设盲，本研究仅对资料收集者和数据分析者设盲，即资料收集者和数据分析者不参加研究对象的干预过程，也不了解研究对象的具体分组。

Blinding：

Since this study involves face-to-face interventions, blinding of both the intervention providers and participants was not feasible. However, single blinding was implemented for the data collectors and statistical analysts. Specifically: The data collectors were not involved in the intervention process and remained unaware of the participants' group assignments. The data analysts were also kept blinded to the allocation details during data processing and statistical evaluation.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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）：

无

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

none

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：

本研究由ICU专科护士询问符合纳入和排除标准的患者家属是否愿意参加本研究，家属同意后将签署知情同意书。为防止因收集资料的人员不同引起的信息偏倚，所有资料均由课题组资料收集员在家属签知情同意书后发放纸质版问卷,现场收集基线资料。干预后由固定的资料收集员在固定的时间进行随访资料收集。随访资料收集主要通过门诊复诊、电话或微信途径进行。对照组在各随访时间节点收集，试验组依据家属实施干预时间,由 SAF-T 干预实施者将干预后资料收集时间节点整理为表格形式并将表格转交给资料收集员进行资料收集。陪患者回门诊复诊的家属由资料收集员现场发放纸质版问卷、当场回收。因特殊原因不能陪患者回门诊复诊的家属，以电话询问的方式进行资料收集，由资料收集员按随访安排表根据问卷所包含的题目和内容条目逐条对家属进行询问，资料收集员仔细听取答案后,在相应量表及相应条目上做好勾选及标记。微信资料收集选择在随访时间节点，通过问卷星将问卷发放给家属,资料收集员通过问卷星后台查看家属填写数据,并对所填写数据进行核查，剔除无效问卷。资料收集时间为第1天干预前、第3 天干预、第 30 天和第 90 天。ICU 后随访资料在研究第 30 天和第 90 天的 48 小时内收集。

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

Specialized ICU nurses screened eligible patients' family members based on the inclusion/exclusion criteria. Willing participants provided informed consent prior to enrollment. To minimize information bias, all baseline data were collected on-site using paper-based questionnaires administered uniformly by trained research staff immediately after consent acquisition. Follow-up data collection was conducted by designated research personnel at predetermined intervals. Control group follow-ups adhered to standardized timepoints, while the experimental group's schedule was customized based on each family's intervention timeline. The SAF-T interventionists documented these individualized follow-up schedules in tracking forms for the research staff. Data collection methods included: In-person clinic visits: Paper questionnaires were distributed and collected on-site. Telephone interviews: For families unable to attend clinic visits, trained staff administered standardized questionnaires via phone, recording responses directly onto assessment scales. WeChat-based collection: At designated follow-ups, questionnaires were distributed through Wenjuanxing, with researchers verifying submitted data and excluding invalid responses. Follow-up timepoints included: Baseline (pre-intervention, Day 1);Post-intervention (Day 3);30-day and 90-day assessments (collected within 48 hours of target dates).

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2025-05-22 09:06:48