简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
叙事疗法在脑卒中主要照顾者中的应用效果
下载XML文档

注册号：

Registration number：

 ChiCTR1900026094 

最近更新日期：

Date of Last Refreshed on：

 2019-09-20 22:58:34 

注册时间：

Date of Registration：

 2019-09-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

叙事疗法在脑卒中主要照顾者中的应用效果

Public title：

Application of Narrative Therapy in Main Caregivers of Stroke

注册题目简写：

English Acronym：

研究课题的正式科学名称：

叙事疗法在脑卒中主要照顾者中的应用效果

Scientific title：

Application of Narrative Therapy in Main Caregivers of Stroke

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：

张玉环 

研究负责人：

隋树杰 

Applicant：

Zhang Yuhuan 

Study leader：

Shujie Sui 

申请注册联系人电话：

Applicant telephone：

 +86 18845761825

研究负责人电话：

Study leader's
telephone：

+86 13946110246

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：

 2802262584@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 ssj512@163.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：

黑龙江省哈尔滨市南岗区保健路124号哈尔滨医科大学附属第二医院全科楼

研究负责人通讯地址：

黑龙江省哈尔滨市南岗区保健路124号哈尔滨医科大学附属第二医院护理学院

Applicant address：

General Building, 124 Baojian Road, Nangang District, Harbin, Heilongjiang.

Study leader's address：

Nursing College of the Second Affiliated Hospital of Harbin Medical University, 124 Baojian Road, Nangang District, Harbin, Heilongjiang.

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：

哈尔滨医科大学附属第二医院神经内科

Applicant's institution：

Department of Neurology, Second Affiliated Hospital of Harbin Medical University

研究负责人所在单位：

哈尔滨医科大学附属第二医院护理学院

Affiliation of the Leader：

Nursing College of the Second Affiliated Hospital of Harbin 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：

 KY2019-2014

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：

哈尔滨医科大学附属第二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Affiliated Hospital of Harbin Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-08-07 00:00:00

伦理委员会联系人：

王永晨

Contact Name of the ethic committee：

Yongchen Wang

伦理委员会联系地址：

黑龙江省哈尔滨市南岗区保健路124号哈尔滨医科大学附属第二医院行政办公楼伦理审查办公室

Contact Address of the ethic committee：

Ethics Review Office, the Administrative Office Building, 124 Baojian Road, Nangang District, Harbin, Heilongjiang.

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：

黑龙江省哈尔滨南岗区保健路哈尔滨医科大学附属第二医院护理学院

Primary sponsor：

Nursing College of the Second Affiliated Hospital of Harbin Medical University

研究实施负责（组长）单位地址：

黑龙江省哈尔滨市南岗区保健路124号

Primary sponsor's address：

124 Baojian Road, Nangang District, Harbin, Heilongjiang.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

黑龙江

市(区县)：

哈尔滨

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

哈尔滨医科大学附属第二医院

具体地址：

南岗区保健路124号

Institution
hospital：

The Second Affiliated Hospital of Harbin Medical University

Address：

124 Baojian Road, Nangang District

经费或物资来源：

哈尔滨医科大学

Source(s) of funding：

Harbin Medical Sciences University

研究疾病：

脑卒中  

Target disease：

cerebral apoplexy

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

（1）了解脑卒中主要照顾者的负性情绪、照顾负担及益处发现水平状况。 （2）明确叙事疗法在改善脑卒中主要照顾者负面情绪、减轻其照顾负担及提高益处发现水平方面的效果。  

Objectives of Study：

(1) To understand the level of negative emotions, burden of care and benefit discovery of the main caregivers of stroke. (2) To clarify the effect of narrative therapy in improving the negative emotions of the main caregivers of stroke, reducing their burden of care and improving the level of benefit discovery.

药物成份或治疗方案详述：

采用试验研究的方法，将叙事疗法应用于脑卒中主要照顾者，明确叙事疗法对脑卒中主要照顾者负面情绪、照顾负担及益处发现水平的影响。实验组对其实施基于叙事疗法的干预方案，对照组对其实施常规护理。实验效果评定指标包括：①负面情绪②；照顾负担；③益处发现。具体干预措施如下： 1. 实验组干预方案 （1）建立信任 脑卒中照顾者在照料过程中会因缺乏各种与疾病康复相关的知识,出现压力、不确定感以及不知所措的状态。研究者应提供相关用药、功能锻炼等系列健康信息指导。以满足脑卒中主要照顾者照护过程中不确定和未满足的信息,在指导的过程中与主要照顾者建立联系，获取其信任。 （2）制定叙事计划 准备叙事记录本：详细记录被访谈者、访谈时间、脑卒中主要照顾者的叙事内容，保证资料准确；准备访谈提纲：为保访谈的顺利进行，每次访谈前制定访谈提纲；访谈具体时间与地点：访谈时间为每周1次，30min/次，持续干预4周；地点科室示教室。 （3）实施叙事疗法 第一阶段：了解问题故事 了解问题：脑卒中主要照顾者所面临的问题可能有：长期压力的堆积，会导致酗酒或摄入药物；照顾者个人与社会相脱离，社会支持变少感到孤立无援；繁重的照顾负担使照顾者经历失业，丧失斗志，部分在职的照顾者会感工作不顺心；照顾重任会使他们产生各种不良情绪，脾气变差，家庭不和谐等。这一阶段研究者通过倾听脑卒中主要照顾者的“问题故事”，使用接纳性语言和开放式发问，引导脑卒中主要照顾者将“问题故事”充分叙说。 第二阶段：问题外化 问题外化目的是将问题与人分离。这一阶段研究者请脑卒中主要照顾者为自己面临的问题取个“特定名字”，并在之后叙事中直接用“特定名字”询问问题对其生活的影响，以帮助脑卒中主要照顾者将目光聚焦在其问题故事上，使脑卒中主要照顾者意识到自己是受问题影响的对象，强化问题与自身无关的意识。只有脱离了问题的约束，脑卒中主要照顾者才能够更客观、更理性、更有力量解决问题。 第三阶段：解构 解构即探索例外故事（特殊意义事件）的来龙去脉的过程。此阶段引导脑卒中主要照顾者探讨回忆过去曾遇到过相似的困境，当时问题是如何得到解决的，取得怎样的效果？从而挖掘并释放脑卒中主要照顾者被掩埋的希望与积极力量。 第四阶段：改写 改写即将例外故事后面隐藏的价值观、正向力量和积极认同，迁移到现在,再迁移到未来,发生改写。这一阶段研究者与脑卒中主要照顾者一起将探索出的“特殊意义事件”进行串接，为其提供新的选择，以构建新的生活视野和积极力量，引导脑卒中主要照顾者发现自己有能力解决目前的问题。 第五阶段：强化积极自我 研究者在治疗结束与追踪巩固阶段可以邀请脑卒中主要照顾者生命中的重要他人，如家属、朋友等作为外部见证人参与其中，并贴合主要照顾者的内心情感需求，创造性的采用运用证书、影音资料等作为治疗性文件，见证照顾者所取得的进步，从而给脑卒中主要照顾者带来存在感、价值感。 （4）回顾反思 每次访谈结束后，重点在于发现问题并制定下一步目标。分析脑卒中主要照顾者现存问题，脑卒中主要照顾者周边有哪些资源可利用，以哪个方面为切入点能触碰其内心的柔软、挖掘出主要照顾者的内在潜能，并思考接下来应解决的问题，在下次访谈中观察该脑卒中主要照顾者的问题有无改善。 (5）评价 干预结束后及结束后3个月对脑卒中主要照顾者身心状态进行评估，从而对医院开展叙事疗法的效果进行评价和总结。 2. 对照组干预方案 给予常规护理，包括健康指导，讲解脑卒中康复相关知识，以及给予鼓励与安慰等常规心理护理。其评估内容、时间与实验组相同。 

Description for medicine or protocol of treatment in detail：

By using the experimental research method, narrative therapy was applied to the primary caretakers of stroke to clarify the influence of narrative therapy on the negative emotions, care burden and benefit discovery level of the primary caretakers of stroke. The experimental group received narrative therapy based intervention program, and the control group received routine care. Experimental effect evaluation index includes: (1) negative emotion; (2) Burden of care; (3) benefit discovery. Specific intervention measures are as follows: 1. intervention scheme of the experimental group (1) build trust Stroke caregivers may experience stress, uncertainty and confusion due to a lack of knowledge related to disease recovery. The researcher should provide a series of health information about medication and exercise. To meet the uncertain and unsatisfied information in the care of the primary caregiver of stroke, to establish contact with the primary caregiver and gain their trust in the guidance process. (2) develop a narrative plan Prepare narrative book: record the interviewee, interview time and narrative content of the primary caregiver of stroke in detail to ensure the accuracy of the data; Prepare interview outline: to ensure the smooth progress of the interview, make an interview outline before each interview; Specific time and place of interview: the interview time was once a week, 30min/ time, and the intervention lasted for 4 weeks. Location: office room. (3) narrative therapy Stage 1: understand the problem story Understand the problem: problems faced by stroke primary caretakers may include: a buildup of chronic stress that can lead to alcoholism or drug use; The individual caregiver is isolated from society and feels less social support; Heavy burden of care makes the caregiver experience unemployment, loss of morale, some on-the-job caregiver will feel unhappy at work; Taking care of them will cause all kinds of bad mood, bad temper, family discord and so on. In this stage, the researchers listened to the "problem story" of the primary caregiver of stroke, and used receptive language and open questioning to guide the primary caregiver of stroke to fully tell the "problem story". Stage 2: externalizing the problem The goal of problem externalization is to separate the problem from the person. This stage the researchers please stroke main caregivers are faced with the problem for himself a "given name", and then the narrative directly or move "given name" ask a question on its life, to help stroke main caregivers focused attention on the story in the problem, make people aware of their main stroke care is affected by the problem of object, strengthening the consciousness of problem has nothing to do with themselves. Only by breaking away from the constraints of the problem can the primary caregiver of stroke be more objective, more rational and more powerful in solving the problem. Stage three: deconstruction Deconstruction is the process of exploring the context of exceptional stories (events of special significance). This stage leads the primary caregiver of stroke to discuss and recall similar difficulties encountered in the past, how the problems were solved and what were the results? So as to excavate and release the hope and positive power of the buried primary caregiver of stroke. Stage 4: rewrite Rewrite will be the exception behind the story hidden values, positive forces and positive identification, move to the present, and then move to the future, rewriting. In this stage, researchers will connect the "special significance events" explored together with the primary caretakers of stroke to provide them with new choices, so as to build a new life vision and positive power, and guide the primary caretakers of stroke to find themselves capable of solving the current problems. Stage 5: strengthen your positive self Researchers at the end of the treatment with tracking phase can invite stroke main caregivers life important others, such as family members, friends, as an external witnesses involved, and joint main caregivers inner emotional needs, creative use as therapeutic use certificate, and multimedia data such as documents, witness the progress made in caregivers, thus bring major stroke caregivers sense, sense of value. (4) review and reflect At the end of each interview, the focus is on identifying problems and setting goals for the next step. Main caregivers existing problems analysis of the stroke, stroke around the main caregivers what are the resources available, based on which aspect point can touch the heart of the soft, digging out the inherent potential of the main caregivers, and think about the next should solve the problem, at the next interview to observe the main caregivers of stroke problem for improvement. (5) evaluation After the intervention and 3 months after the intervention, the physical and mental states of the primary caretakers for stroke were evaluated, so as to evaluate and summarize the effect of narrative therapy in the hospital. 2. intervention plan of the control group Give routine nursing, including health guidance, explanation of stroke rehabilitation related knowledge, and give encouragement and comfort and other routine psychological nursing. The evaluation content and time were the same as the experimental group. 

纳入标准：

Inclusion criteria

排除标准：

（1）不愿接受干预的脑卒中主要照顾者；
（2）中途停止对患者照护的脑卒中主要照顾者；
（3）自行选择退出脑卒中主要照顾者。

Exclusion criteria：

(1) the main caregivers of stroke who are unwilling to accept intervention;
(2) the main caregivers of stroke who stop caring for patients in the middle of the way;
(3) the main caregivers of stroke who choose to withdraw from the main caregivers of stroke by themselves.

研究实施时间：

Study execute time：

从 From 2019-09-30 00:00:00至 To 2020-02-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-10-05 00:00:00 至 To 2020-01-06 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 40

Group：

control group

Sample size：

干预措施：

常规护理

干预措施代码：

Intervention：

Conventional nursing

Intervention code：

组别：

试验组（叙事疗法组）

样本量：

 40

Group：

Experimental group (narrative therapy group)

Sample size：

干预措施：

叙事疗法

干预措施代码：

Intervention：

Narrative therapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 黑龙江省 

市(区县)：

 哈尔滨市 

Country：

China

Province：

Heilongjiang

City：

Harbin

单位(医院)：

 哈尔滨医科大学附属第二医院 

单位级别：

 三甲级 

Institution
hospital：

The Second Affiliated Hospital of Harbin Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

益处发现

指标类型：

主要指标

Outcome：

Benefits finding

Type：

Primary indicator

测量时间点：

干预开始前、干预后及干预结束后3个各月

测量方法：

问卷测量

Measure time point of outcome：

Before, after and 3 months after the intervention

Measure method：

Questionnaire to measure

指标中文名：

负性情绪

指标类型：

次要指标

Outcome：

Negative emotions

Type：

Secondary indicator

测量时间点：

干预开始前、干预后及干预结束后3个各月

测量方法：

问卷测量

Measure time point of outcome：

Before, after and 3 months after the intervention

Measure method：

Questionnaire to measure

指标中文名：

照顾负担

指标类型：

次要指标

Outcome：

Take care of the burden

Type：

Secondary indicator

测量时间点：

干预开始前、干预后及干预结束后3个各月

测量方法：

问卷测量

Measure time point of outcome：

Before, after and 3 months after the intervention

Measure method：

Questionnaire to measure

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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 75 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）：

excel表格产生随机数列。

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

Excel table generates random sequence.

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：

单盲：研究对象及统计人员不知道分组情况，研究者了解分组情况。

Blinding：

Single blind: subjects and statisticians do not know the grouping, researchers know the grouping.

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

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）：

暂无

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

无

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：

暂无

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

无

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：

  2019-09-20 22:58:18
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统