ChiCTR2500114232 版本V1.0 版本创建时间2025/12/09 15:22:27 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：

 ChiCTR2500114232 

最近更新日期：

Date of Last Refreshed on：

 2025-12-09 15:22:17 

注册时间：

Date of Registration：

 2025-12-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

Public title：

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: A Randomized Controlled Trial

Scientific title：

Effect of Combined Stress Ball and Lavender Oil on Pain and Anxiety during Arteriovenous Cannulation in Hemodialysis Patients: 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：

Dhrgam Hameed Ibrahim 

研究负责人：

Hakemia Shaker Hasen 

Applicant：

Dhrgam Hameed Ibrahim 

Study leader：

Hakemia Shaker Hasen 

申请注册联系人电话：

Applicant telephone：

 +964 772 267 5755

研究负责人电话：

Study leader's
telephone：

+964 770 296 7081

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：

 Dorgham.Hameed2402m@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

 dr.hakemia@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：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

研究负责人通讯地址：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

Applicant address：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

Study leader's address：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

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：

University of Baghdad, College of Nursing

Applicant's institution：

University of Baghdad, College of Nursing

研究负责人所在单位：

University of Baghdad, College of Nursing

Affiliation of the Leader：

University of Baghdad, College of Nursing

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：

 40

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：

 2025-11-25 00:00:00

伦理委员会联系人：

Prof. Wissam J. Kassim, Ph.D

Contact Name of the ethic committee：

Prof. Wissam J. Kassim, Ph.D

伦理委员会联系地址：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

Contact Address of the ethic committee：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +964 770 785 8731

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：

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：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

Primary sponsor's address：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

Iraq

省(直辖市)：

Baghdad

市(区县)：

Country：

Iraq

Province：

Baghdad

City：

单位(医院)：

College of Nursing, University of Baghdad

具体地址：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

Institution
hospital：

College of Nursing, University of Baghdad

Address：

College of Nursing, University of Baghdad, Bab Al-Mu’adham, Baghdad, Iraq

经费或物资来源：

Self-funded by the investigator

Source(s) of funding：

Self-funded by the investigator

研究疾病：

End-stage renal disease (ESRD) on maintenance hemodialysis  

Target disease：

End-stage renal disease (ESRD) on maintenance hemodialysis

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：

1.To evaluate the effect of a combination stress ball and lavender oil on pain during arteriovenous cannulation in hemodialysis patients. 2.To evaluate the effect of a combination stress ball and lavender oil on anxiety during arteriovenous cannulation in hemodialysis patients.  

Objectives of Study：

1.To evaluate the effect of a combination stress ball and lavender oil on pain during arteriovenous cannulation in hemodialysis patients. 2.To evaluate the effect of a combination stress ball and lavender oil on anxiety during arteriovenous cannulation in hemodialysis 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. The subject must be 18 years of age or older. 2. Be receiving regular and continuous hemodialysis sessions via a valid vascular access (fistula) at least three months 3. Be able to understand the study details, provide informed consent, and accurately report their own pain or anxiety levels. 4. Have sufficient physical ability to use a stress ball in the hand or limb opposite their vascular access site. 5. Have no known allergies to lavender oil or its carrier ingredient. They must also be free of any active respiratory conditions that could be affected by inhaling the scent.

Inclusion criteria

1. The subject must be 18 years of age or older. 2. Be receiving regular and continuous hemodialysis sessions via a valid vascular access (fistula) at least three months 3. Be able to understand the study details, provide informed consent, and accurately report their own pain or anxiety levels. 4. Have sufficient physical ability to use a stress ball in the hand or limb opposite their vascular access site. 5. Have no known allergies to lavender oil or its carrier ingredient. They must also be free of any active respiratory conditions that could be affected by inhaling the scent.

排除标准：

1. Have a history of allergic reactions to lavender oil or any components of the preparation used in this study. 2. Have an active infection or severe complication at the vascular access site, or any other unstable medical condition that could place the participant at increased risk. 3. Taking painkillers, sedatives, or anti-anxiety medications during three-hour prior HD 4. Severe cognitive impairment, severe psychiatric disorder, or language impairment that impedes informed consent or reliable self-reporting. 5. Physical inability to use a stress ball (such as amputation or paralysis), or any other condition that the study administrators deem a contraindication to participation.

Exclusion criteria：

1. Have a history of allergic reactions to lavender oil or any components of the preparation used in this study. 2. Have an active infection or severe complication at the vascular access site, or any other unstable medical condition that could place the participant at increased risk. 3. Taking painkillers, sedatives, or anti-anxiety medications during three-hour prior HD 4. Severe cognitive impairment, severe psychiatric disorder, or language impairment that impedes informed consent or reliable self-reporting. 5. Physical inability to use a stress ball (such as amputation or paralysis), or any other condition that the study administrators deem a contraindication to participation.

研究实施时间：

Study execute time：

从 From 2025-12-08 00:00:00至 To 2026-03-07 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-12-10 00:00:00 至 To 2026-01-10 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 40

Group：

Intervention group

Sample size：

干预措施：

Combined stress ball exercise and lavender oil inhalation. Patients will squeeze a 5 cm anti-stress ball with the non-fistula hand starting 5 minutes before AVF cannulation and continuing during the procedure. Two drops of diluted lavender oil (1:10 with sweet almond oil) will be placed on sterile gauze and positioned 5 cm from the nose for inhalation 5 minutes before and during cannulation.

干预措施代码：

Intervention：

Combined stress ball exercise and lavender oil inhalation. Patients will squeeze a 5 cm anti-stress ball with the non-fistula hand starting 5 minutes before AVF cannulation and continuing during the procedure. Two drops of diluted lavender oil (1:10 with sweet almond oil) will be placed on sterile gauze and positioned 5 cm from the nose for inhalation 5 minutes before and during cannulation.

Intervention code：

组别：

Control group

样本量：

 40

Group：

Control group

Sample size：

干预措施：

Routine care during AVF cannulation without stress ball use or lavender oil inhalation. No additional intervention will be provided.

干预措施代码：

Intervention：

Routine care during AVF cannulation without stress ball use or lavender oil inhalation. No additional intervention will be provided.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Al-Anbar 

市(区县)：

 Fallujah 

Country：

Iraq

Province：

Al-Anbar

City：

Fallujah

单位(医院)：

 Fallujah Teaching Hospital – Dialysis Unit 

单位级别：

 Teaching Hospital  

Institution
hospital：

Fallujah Teaching Hospital – Dialysis Unit

Level of the institution：

Teaching Hospital

国家：

 Iraq

省(直辖市)：

 Al-Anbar 

市(区县)：

 Al-Amiriyah 

Country：

Iraq

Province：

Al-Anbar

City：

Al-Amiriyah

单位(医院)：

 Al-Amiriyah Dialysis Center 

单位级别：

 General hospital 

Institution
hospital：

Al-Amiriyah Dialysis Center

Level of the institution：

General hospital

测量指标：

Outcomes：

指标中文名：

Pain during AV cannulation

指标类型：

主要指标

Outcome：

Pain during AV cannulation

Type：

Primary indicator

测量时间点：

Before cannulation and two minutes after cannulation

测量方法：

Visual Analogue Scale (VAS)

Measure time point of outcome：

Before cannulation and two minutes after cannulation

Measure method：

Visual Analogue Scale (VAS)

指标中文名：

Anxiety level during AV cannulation

指标类型：

主要指标

Outcome：

Anxiety level during AV cannulation

Type：

Primary indicator

测量时间点：

Before cannulation and two minutes after cannulation

测量方法：

Visual Analogue Scale for Anxiety (VAS-A）

Measure time point of outcome：

Before cannulation and two minutes after cannulation

Measure method：

Visual Analogue Scale for Anxiety (VAS-A)

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

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）：

Simple randomization was used based on the pre-assigned hemodialysis schedule. Patients attending sessions on Saturday, Monday, and Wednesday were allocated to the intervention group, while those dialyzing on Sunday, Tuesday, and Thursday were assigned to the control group. The allocation process was not influenced by the researcher; the distribution was determined naturally by the dialysis unit schedule. A nurse from the dialysis unit, who was not involved in the intervention or outcome assessment, supervised the grouping process to ensure unbiased and independent allocation.

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

Simple randomization was used based on the pre-assigned hemodialysis schedule. Patients attending sessions on Saturday, Monday, and Wednesday were allocated to the intervention group, while those dialyzing on Sunday, Tuesday, and Thursday were assigned to the control group. The allocation process was not influenced by the researcher; the distribution was determined naturally by the dialysis unit schedule. A nurse from the dialysis unit, who was not involved in the intervention or outcome assessment, supervised the grouping process to ensure unbiased and independent allocation.

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：

Single-blind (participant-blind) study. Participants were unaware of their group allocation, while the nurse collecting outcome data was not involved in delivering the intervention to ensure unbiased assessment.

Blinding：

Single-blind (participant-blind) study. Participants were unaware of their group allocation, while the nurse collecting outcome data was not involved in delivering the intervention to ensure unbiased assessment.

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）：

Individual participant data (IPD) will not be shared due to privacy protection and institutional policy. Only aggregated statistical re

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

Individual participant data (IPD) will not be shared due to privacy protection and institutional policy. Only aggregated statistical results will be available upon request.

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：

Data will be collected using the Visual Analogue Scale (VAS) for pain and anxiety during AVF cannulation. All data will be recorded on paper case report forms (CRFs) and then entered into an electronic spreadsheet by the research team. Data accuracy will be ensured through double-entry verification and regular review by the principal investigator. All data will be stored securely with restricted access to authorized research personnel only.

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

Data will be collected using the Visual Analogue Scale (VAS) for pain and anxiety during AVF cannulation. All data will be recorded on paper case report forms (CRFs) and then entered into an electronic spreadsheet by the research team. Data accuracy will be ensured through double-entry verification and regular review by the principal investigator. All data will be stored securely with restricted access to authorized research personnel only.

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：

  2025-12-09 15:22:17