ChiCTR2500104908 版本V1.0 版本创建时间2025/06/25 11:20:30 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：

 ChiCTR2500104908 

最近更新日期：

Date of Last Refreshed on：

 2025-06-25 11:20:10 

注册时间：

Date of Registration：

 2025-06-25 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of a Structured Supportive and Palliative Caring Approach on the Incidence of Arrhythmia, Chest Pain and Anxiety in Patients Admitted to the Cardiac Care Unit

Public title：

Effect of a Structured Supportive and Palliative Caring Approach on the Incidence of Arrhythmia, Chest Pain and Anxiety in Patients Admitted to the Cardiac Care Unit

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of a Structured Supportive and Palliative Caring Approach on the Incidence of Arrhythmia, Chest Pain and Anxiety in Patients Admitted to the Cardiac Care Unit

Scientific title：

Effect of a Structured Supportive and Palliative Caring Approach on the Incidence of Arrhythmia, Chest Pain and Anxiety in Patients Admitted to the Cardiac Care Unit: 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：

Alaa Jawad Kadhim 

研究负责人：

Alaa Jawad Kadhim 

Applicant：

Alaa Jawad Kadhim 

Study leader：

Alaa Jawad Kadhim 

申请注册联系人电话：

Applicant telephone：

 +964 770 352 0314

研究负责人电话：

Study leader's
telephone：

+964 770 352 0314

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：

 alaaj@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 alaaj@conursing.uobaghdad.edu.iq

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：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

研究负责人通讯地址：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

Applicant address：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

Study leader's address：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

申请注册联系人邮政编码：

Applicant postcode：

 10045

研究负责人邮政编码：

Study leader's postcode：

 10045

申请人所在单位：

University of Baghdad/ College of Nursing/ Department of Adult Nursing

Applicant's institution：

University of Baghdad/ College of Nursing/ Department of Adult Nursing

研究负责人所在单位：

College of Nursing, University of Baghdad

Affiliation of the Leader：

College of Nursing, University of Baghdad

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：

 02

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：

Research Ethical Approval Committee- College of Nursing, University of Baghdad

Name of the ethic committee：

Research Ethical Approval Committee- College of Nursing, University of Baghdad

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-02-09 00:00:00

伦理委员会联系人：

Associate Prof. Wafaa Abd Ali Hattab, Ph.D

Contact Name of the ethic committee：

Associate Prof. Wafaa Abd Ali Hattab, Ph.D

伦理委员会联系地址：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

Contact Address of the ethic committee：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 774 285 7710

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 nursing@conursing.uobaghdad.edu.iq

研究实施负责（组长）单位：

College of Nursing, University of Baghdad

Primary sponsor：

College of Nursing, University of Baghdad

研究实施负责（组长）单位地址：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

Primary sponsor's address：

Al mashtil, New Baghdad, Baghdad, Street 729, Iraq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Alrusafa

市(区县)：

Baghdad

Country：

Iraq

Province：

Alrusafa

City：

Baghdad

单位(医院)：

University of Baghdad, College of Nursing

具体地址：

Bab Al muaadham, Baghdad, Street 729

Institution
hospital：

University of Baghdad, College of Nursing

Address：

Bab Al muaadham, Baghdad, Street 729

经费或物资来源：

Self-financed

Source(s) of funding：

Self-financed

研究疾病：

Chest pain, anxiety and cardiac arrhythmia  

Target disease：

Chest pain, anxiety and cardiac arrhythmia

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：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

Given the importance of chest pain and cardiac arrhythmia in patients admitted to the CCU, and the lack of a comprehensive study that has examined the role of supportive and palliative care in these hospitalized patients, the researcher decides to conduct a study aimed to determine effect of a structured supportive and palliative caring approach on arrhythmia and chest pain in patients of cardiac care unit.  

Objectives of Study：

Given the importance of chest pain and cardiac arrhythmia in patients admitted to the CCU, and the lack of a comprehensive study that has examined the role of supportive and palliative care in these hospitalized patients, the researcher decides to conduct a study aimed to determine effect of a structured supportive and palliative caring approach on arrhythmia and chest pain in patients of cardiac care unit.

药物成份或治疗方案详述：

In this study, the code of ethics was first obtained from the Ethics Approvals. After entering the research environment and obtaining permission from the hospital's research vice-chancellor, an informed consent form was provided to the participants. Then, based on the simple random sampling method in such a way that each member of the participants are given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables), patients hospitalized in the CCU of were divided into two control and intervention groups. Initially (before the intervention), a demographic information questionnaire was completed in both groups, and the patients' chest pain was assessed based on the visual pain scale. Their anxiety level was also assessed using the Spielberger questionnaire, and an electrocardiogram was taken to examine the type and extent of cardiac arrhythmias. Then, routine treatments were continued for the control group, and in the intervention group, in addition to routine treatments, a structured supportive and palliative caring approach was implemented. This approach was implemented and taught in eight sessions (This training was conducted face-to-face and in person, with pamphlets and brochures being given to groups in the second, third and fourth sessions , but the first sessions were conducted individually, given that the participants had different types of illnesses also the last session was conducted individually)by multidisciplinary health care team, including: physician, nurse, occupational therapist, physiotherapist, and psychologist. Three days(posttest) and seven days(follow-up) after the intervention, chest pain and anxiety indices were measured again-, and a control electrocardiogram was also performed. The obtained data were collected and sent for analysis. 

Description for medicine or protocol of treatment in detail：

In this study, the code of ethics was first obtained from the Ethics Approvals. After entering the research environment and obtaining permission from the hospital's research vice-chancellor, an informed consent form was provided to the participants. Then, based on the simple random sampling method in such a way that each member of the participants are given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables), patients hospitalized in the CCU of were divided into two control and intervention groups. Initially (before the intervention), a demographic information questionnaire was completed in both groups, and the patients' chest pain was assessed based on the visual pain scale. Their anxiety level was also assessed using the Spielberger questionnaire, and an electrocardiogram was taken to examine the type and extent of cardiac arrhythmias. Then, routine treatments were continued for the control group, and in the intervention group, in addition to routine treatments, a structured supportive and palliative caring approach was implemented. This approach was implemented and taught in eight sessions (This training was conducted face-to-face and in person, with pamphlets and brochures being given to groups in the second, third and fourth sessions , but the first sessions were conducted individually, given that the participants had different types of illnesses also the last session was conducted individually)by multidisciplinary health care team, including: physician, nurse, occupational therapist, physiotherapist, and psychologist. Three days(posttest) and seven days(follow-up) after the intervention, chest pain and anxiety indices were measured again-, and a control electrocardiogram was also performed. The obtained data were collected and sent for analysis. 

纳入标准：

All patients admitted to the intensive care unit with cardiac problems, who were fully conscious and in a stable state, no underlying disease, no mental illness, no hearing or visual problems, and minimal literacy.

Inclusion criteria

All patients admitted to the intensive care unit with cardiac problems, who were fully conscious and in a stable state, no underlying disease, no mental illness, no hearing or visual problems, and minimal literacy.

排除标准：

Lack of consent to continue the study for any reason, patient deterioration and emergency conditions, discharge or transfer before 24 hours.

Exclusion criteria：

Lack of consent to continue the study for any reason, patient deterioration and emergency conditions, discharge or transfer before 24 hours.

研究实施时间：

Study execute time：

从 From 2025-02-09 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-15 00:00:00 至 To 2025-12-15 00:00:00

干预措施：

Interventions：

组别：

Control

样本量：

 37

Group：

Control

Sample size：

干预措施：

Conventional care

干预措施代码：

Intervention：

Conventional care

Intervention code：

组别：

Intervention

样本量：

 37

Group：

Intervention

Sample size：

干预措施：

Conventional care and a structured supportive and palliative caring approach ( The approach used by us was designed following the guidelines provided by the World Health Organization 2018, p. 52, Issn:978-92-4-151447-7 (electronic version), and the World Health Organization 2021, p.52, Issn:978-92-4-003516-4 (electronic version) ).

干预措施代码：

Intervention：

Conventional care and a structured supportive and palliative caring approach ( The approach used by us was designed following the guidelines provided by the World Health Organization 2018, p. 52, Issn:978-92-4-151447-7 (electronic version), and the World Health Organization 2021, p.52, Issn:978-92-4-003516-4 (electronic version) ).

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Alrusafa 

市(区县)：

 Baghdad 

Country：

Iraq

Province：

Alrusafa

City：

Baghdad

单位(医院)：

 University of Baghdad, College of Nursing 

单位级别：

 Tertiary A 

Institution
hospital：

University of Baghdad, College of Nursing

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

Arrhythmia

指标类型：

主要指标

Outcome：

Arrhythmia

Type：

Primary indicator

测量时间点：

Three days and seven days after the intervention

测量方法：

Electrocardiogram machine

Measure time point of outcome：

Three days and seven days after the intervention

Measure method：

Electrocardiogram machine

指标中文名：

Chest Pain

指标类型：

主要指标

Outcome：

Chest Pain

Type：

Primary indicator

测量时间点：

Three days and seven days after the intervention

测量方法：

Visual Analog Scale

Measure time point of outcome：

Three days and seven days after the intervention

Measure method：

Visual Analog Scale

指标中文名：

Anxiety

指标类型：

主要指标

Outcome：

Anxiety

Type：

Primary indicator

测量时间点：

Three days and seven days after the intervention

测量方法：

The Spielberger State-Trait Anxiety Inventory

Measure time point of outcome：

Three days and seven days after the intervention

Measure method：

The Spielberger State-Trait Anxiety Inventory

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

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 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）：

Random selection and assignment Manual methods: based on the simple random sampling method in such a way that each member of the participants are given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables)

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

Random selection and assignment Manual methods: based on the simple random sampling method in such a way that each member of the participants are given a number. The numbers are then placed in a drawing container. Finally, the numbers are selected, recorded, and returned to the container. (to replicate and control confounding variables)

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：

Non blinding

Blinding：

Non blinding

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）：

NA

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

NA

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：

Questionnaires and Scale were used to collect data, and databases were used to manage data.

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

Questionnaires and Scale were used to collect data, and databases were used to manage data.

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：

  2025-06-25 11:20:10