ChiCTR2500114074 版本V1.0 版本创建时间2025/12/08 08:53:10 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：

ChiCTR2500114074 

最近更新日期：

Date of Last Refreshed on：

2025-12-08 08:52:53 

注册时间：

Date of Registration：

2025-12-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Effect of Listening to Quran versus Verbal Communication on Respiratory Suctioning-Induced Pain and Agitation among Intubated Patients: A Randomized Controlled Trail

Public title：

Effect of Listening to Quran versus Verbal Communication on Respiratory Suctioning-Induced Pain and Agitation among Intubated Patients: A Randomized Controlled Trail

注册题目简写：

LQ-VC

English Acronym：

LQ-VC

研究课题的正式科学名称：

Effect of Listening to Quran versus Verbal Communication on Pain and Agitation Inducing Suctioning among Intubated Patients: A Randomized Controlled Trial

Scientific title：

Effect of Listening to Quran versus Verbal Communication on Pain and Agitation Inducing Suctioning among Intubated Patients: A Randomized Controlled Trial

研究课题代号(代码)：

Study subject ID：

 ICU-2025-Quran

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：

Hassan Munther Noman Al-Sultani 

研究负责人：

Hassan Munther Noman Al-Sultani 

Applicant：

Hassan Munther Noman Al-Sultani 

Study leader：

Hassan Munther Noman Al-Sultani 

申请注册联系人电话：

Applicant telephone：

+964 783 101 0492

研究负责人电话：

Study leader's telephone：

+964 783 101 0492

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：

Hasan.Monzer1704a@conursing.uobaghdad.edu.iq

研究负责人电子邮件：

Study leader's E-mail：

Hasan.Monzer1704a@conursing.uobaghdad.edu.iq

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://conursing.uobaghdad.edu.iq

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

https://conursing.uobaghdad.edu.iq

申请注册联系人通讯地址：

Iraq, Baghdad

研究负责人通讯地址：

Iraq, Baghdad

Applicant address：

Iraq, Baghdad

Study leader's address：

Iraq, Baghdad

申请注册联系人邮政编码：

Applicant postcode：

10047

研究负责人邮政编码：

Study leader's postcode：

10047

申请人所在单位：

College of Nursing, University of Baghdad, Iraq

Applicant's institution：

College of Nursing, University of Baghdad, Iraq

研究负责人所在单位：

College of Nursing, University of Baghdad, Iraq

Affiliation of the Leader：

College of Nursing, University of Baghdad, Iraq

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

27

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：

2025-11-19 00:00:00

伦理委员会联系人：

prof.Wissam J. Kassim

Contact Name of the ethic committee：

prof.Wissam J. Kassim

伦理委员会联系地址：

College of Nursing, University of Baghdad, Bab Al Mua'adham, Baghdad, Iraq

Contact Address of the ethic committee：

College of Nursing, University of Baghdad, Bab Al Mua'adham, Baghdad, 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：

University of Baghdad

Primary sponsor：

University of Baghdad

研究实施负责（组长）单位地址：

Bab Al Mua'adham, Baghdad, Iraq

Primary sponsor's address：

Bab Al Mua'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)：

市(区县)：

Country：

Iraq

Province：

Baghdad

City：

Baghdad

单位(医院)：

University of Baghdad

具体地址：

Bab Al Mua'adham, Baghdad, Iraq

Institution
hospital：

University of Baghdad

Address：

Bab Al Mua'adham, Baghdad, Iraq

经费或物资来源：

Source(s) of funding：

self-financing

Target disease：

Pain and Agitation in Intubated Patients

Target disease code：

R52

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：

随机交叉对照 

Study design：

Cross-over 

研究目的：

the study aims: 1- to compare the effect of listening to Quran versus Verbal communication on pain inducing-suctioning among intubated patients to determine which intervention is more effectiveness. 2- to compare the effect of listening to Quran versus Verbal communication on agitation inducing-suctioning among intubated patients to determine which intervention is more effectiveness. 3- to examine the association between selected sociodemographic variables with pain and agitation levels among intubated patients.  

Objectives of Study：

the study aims: 1- to compare the effect of listening to Quran versus Verbal communication on pain inducing-suctioning among intubated patients to determine which intervention is more effectiveness. 2- to compare the effect of listening to Quran versus Verbal communication on agitation inducing-suctioning among intubated patients to determine which intervention is more effectiveness. 3- to examine the association between selected sociodemographic variables with pain and agitation levels among intubated patients.

药物成份或治疗方案详述：

this study utilizes a randomized crossover design (within-subject design), where each participant serves as their own control, each patient will undergo three separate endotracheal suctioning episodes in randomized order, separated by a washout period of ( 45 minutes) to prevent carry-over effects: standard care ( suctioning protocol): all participants will undergo endotracheal suctioning according to the standard ICU protocol using (open/closed) suction system to ensure consistency in the pain-inducing stimulus. 1. intervention episode A (Quran Recitation): the patient listens to a recording of the holy Quran via headphones starting (20 minutes) before suctioning and continuing until the procedure ends. 2. intervention episode B (verbal communication): the patient receives structured verbal reassurance and procedural explanation from the researcher immediately before and during the suctioning process. 3. control episode C (standard care): the patient undergoes routine suctioning according to standard ICU protocols without any additional auditory or verbal intervention, serving as the baseline for comparison. Note: the sequence of these three episode will be randomized for each patient.  

Description for medicine or protocol of treatment in detail：

this study utilizes a randomized crossover design (within-subject design), where each participant serves as their own control, each patient will undergo three separate endotracheal suctioning episodes in randomized order, separated by a washout period of ( 45 minutes) to prevent carry-over effects: standard care ( suctioning protocol): all participants will undergo endotracheal suctioning according to the standard ICU protocol using (open/closed) suction system to ensure consistency in the pain-inducing stimulus. 1. intervention episode A (Quran Recitation): the patient listens to a recording of the holy Quran via headphones starting (20 minutes) before suctioning and continuing until the procedure ends. 2. intervention episode B (verbal communication): the patient receives structured verbal reassurance and procedural explanation from the researcher immediately before and during the suctioning process. 3. control episode C (standard care): the patient undergoes routine suctioning according to standard ICU protocols without any additional auditory or verbal intervention, serving as the baseline for comparison. Note: the sequence of these three episode will be randomized for each patient.  

纳入标准：

inclusion criteria for this study is: 1. Adult Muslim patients on mechanical ventilation with endotracheal tube. 2. Age 18 years and older. 3. Stable vital signs based on monitor devices. 4. conscious level 5-10 based on Glasgow coma scale. 5. admitted to ICU from 24 hours and more. 6. both sex (male, female). 7. not on contentious deep sedation.

Inclusion criteria

inclusion criteria for this study is: 1. Adult Muslim patients on mechanical ventilation with endotracheal tube. 2. Age 18 years and older. 3. Stable vital signs based on monitor devices. 4. conscious level 5-10 based on Glasgow coma scale. 5. admitted to ICU from 24 hours and more. 6. both sex (male, female). 7. not on contentious deep sedation.

排除标准：

the exclusion criteria is: 1. patients with brain death or brain damage. 2. conscious level less than 4 based on GCS. 3. hearing impairment or disorder 4. extubated patients. 5. change in type of sedation or dosage less than 2 hours before of intervention. 6. quadriplegia paralysis 7. sedation level 0,-4,-5 based on Richmond agitation-sedation scale. 8. patients with otorrhea & rhinorrhea, and trauma in facial and temporal lobe.

Exclusion criteria：

the exclusion criteria is: 1. patients with brain death or brain damage. 2. conscious level less than 4 based on GCS. 3. hearing impairment or disorder 4. extubated patients. 5. change in type of sedation or dosage less than 2 hours before of intervention. 6. quadriplegia paralysis 7. sedation level 0,-4,-5 based on Richmond agitation-sedation scale. 8. patients with otorrhea & rhinorrhea, and trauma in facial and temporal lobe.

研究实施时间：

Study execute time：

从 From 2025-12-09 00:00:00至 To 2025-12-10 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-12-09 00:00:00 至 To 2025-12-10 00:00:00  

干预措施：

Interventions：

组别：

Test group

样本量：

44

Group：

Test group

Sample size：

干预措施：

this study utilizes a randomized crossover design (within-subject design), where each participant serves as their own control, each patient will undergo three separate endotracheal suctioning episodes in randomized order, separated by a washout period of ( 45 minutes) to prevent carry-over effects: standard care ( suctioning protocol): all participants will undergo endotracheal suctioning according to the standard ICU protocol using (open/closed) suction system to ensure consistency in the pain-inducing stimulus. 1. intervention episode A (Quran Recitation): the patient listens to a recording of the holy Quran via headphones starting (20 minutes) before suctioning and continuing until the procedure ends. 2. intervention episode B (verbal communication): the patient receives structured verbal reassurance and procedural explanation from the researcher immediately before and during the suctioning process. 3. control episode C (standard care): the patient undergoes routine suctioning according to standard ICU protocols without any additional auditory or verbal intervention, serving as the baseline for comparison. Note: the sequence of these three episode will be randomized for each patient.

干预措施代码：

Intervention：

this study utilizes a randomized crossover design (within-subject design), where each participant serves as their own control, each patient will undergo three separate endotracheal suctioning episodes in randomized order, separated by a washout period of ( 45 minutes) to prevent carry-over effects: standard care ( suctioning protocol): all participants will undergo endotracheal suctioning according to the standard ICU protocol using (open/closed) suction system to ensure consistency in the pain-inducing stimulus. 1. intervention episode A (Quran Recitation): the patient listens to a recording of the holy Quran via headphones starting (20 minutes) before suctioning and continuing until the procedure ends. 2. intervention episode B (verbal communication): the patient receives structured verbal reassurance and procedural explanation from the researcher immediately before and during the suctioning process. 3. control episode C (standard care): the patient undergoes routine suctioning according to standard ICU protocols without any additional auditory or verbal intervention, serving as the baseline for comparison. Note: the sequence of these three episode will be randomized for each patient.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

 Baghdad 

Country：

Iraq  

Province：

Baghdad 

City：

Baghdad 

单位(医院)：

Baghdad Teaching Hospital  

单位级别：

Tertiary  

Institution
hospital：

Baghdad Teaching Hospital

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

 Baghdad 

Country：

Iraq  

Province：

Baghdad 

City：

Baghdad 

单位(医院)：

Ghazi Al-Hariri hospital for surgical specialty 

单位级别：

Tertiary  

Institution
hospital：

Ghazi Al-Hariri hospital for surgical specialty

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Baghdad 

市(区县)：

 Baghdad 

Country：

Iraq  

Province：

Baghdad 

City：

Baghdad 

单位(医院)：

IRAQ-KOREA critical care specialty hospital 

单位级别：

Tertiary  

Institution
hospital：

IRAQ-KOREA critical care specialty hospital

Level of the institution：

tertiary

国家：

 Iraq

省(直辖市)：

 Babylon  

市(区县)：

 Hillah  

Country：

Iraq 

Province：

Babylon  

City：

Hillah  

单位(医院)：

Al- Hillah Teaching Hospital  

单位级别：

Tertiary  

Institution
hospital：

Al- Hillah Teaching Hospital

Level of the institution：

tertiary

国家：

 Iraq

省(直辖市)：

 Babylon  

市(区县)：

 Hillah  

Country：

Iraq 

Province：

Babylon  

City：

Hillah  

单位(医院)：

Al-Imam Al Sadiq teaching hospital  

单位级别：

Tertiary  

Institution
hospital：

Al-Imam Al Sadiq teaching hospital

Level of the institution：

tertiary

国家：

 Iraq

省(直辖市)：

 Karbala  

市(区县)：

 Karbala  

Country：

Iraq 

Province：

Karbala  

City：

Karbala  

单位(医院)：

Al-Imam Al-Hussein teaching hospital  

单位级别：

Tertiary  

Institution
hospital：

Al-Imam Al-Hussein teaching hospital

Level of the institution：

tertiary

国家：

 Iraq

省(直辖市)：

 Najaf  

市(区县)：

 Najaf  

Country：

Iraq  

Province：

Najaf  

City：

Najaf  

单位(医院)：

Al-Najaf teaching hospital  

单位级别：

Tertiary  

Institution
hospital：

Al-Najaf teaching hospital

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Najaf  

市(区县)：

 Najaf  

Country：

Iraq  

Province：

Najaf  

City：

Najaf  

单位(医院)：

Al-Furat Al-Awsat Teaching Hospital  

单位级别：

Tertiary  

Institution
hospital：

Al-Furat Al-Awsat Teaching Hospital

Level of the institution：

Tertiary

国家：

 Iraq

省(直辖市)：

 Al-Qadisiyah  

市(区县)：

 Al-Qadisiyah  

Country：

Iraq  

Province：

Al-Qadisiyah  

City：

Al-Diwaniya  

单位(医院)：

Al-Diwaniya Teaching Hospital  

单位级别：

Tertiary  

Institution
hospital：

Al-Diwaniya Teaching Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

pain intensity

指标类型：

主要指标

Outcome：

pain intensity

Type：

Primary indicator

测量时间点：

immediately pre-intervention, during, 5 minute post-intervention

测量方法：

Behavioral Pain Scale (BPS)

Measure time point of outcome：

immediately pre-intervention, during, 5 minute post-intervention

Measure method：

Behavioral Pain Scale (BPS)

指标中文名：

Agitation

指标类型：

主要指标

Outcome：

Agitation

Type：

Primary indicator

测量时间点：

immediately pre-intervention, during, 5 minute post-intervention

测量方法：

Richmond Agitation Sedation Scale (RASS)

Measure time point of outcome：

immediately pre-intervention, during, 5 minute post-intervention

Measure method：

Richmond Agitation Sedation Scale (RASS)

指标中文名：

Level of Consciousness

指标类型：

次要指标

Outcome：

Level of Consciousness

Type：

Secondary indicator

测量时间点：

immediately pre-intervention, during, 5 minute post-intervention

测量方法：

Glasgow coma scale (GCS)

Measure time point of outcome：

immediately pre-intervention, during, 5 minute post-intervention

Measure method：

Glasgow coma scale (GCS)

指标中文名：

Vital Signs

指标类型：

次要指标

Outcome：

Vital Signs

Type：

Secondary indicator

测量时间点：

immediately pre-intervention, during, 5 minute post-intervention

测量方法：

monitor devices

Measure time point of outcome：

immediately pre-intervention, during, 5 minute post-intervention

Measure method：

monitor devices

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

 使用后销毁  

说明

Fate of sample：

Destruction after use  

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）：

the randomization will be achieved according to the order of the sequences in a method known as systematic rotation method with true randomness. there will be six sequences will be written on slips of paper, one sequence per slip and placed in bowel and pulled out in sequence by a person not involved in the study to determine the order of the sequences. after determine the sequences, the first participant who meet to inclusion criteria will be randomly selected by lottery. the next participant will have the next series applied after the series applied to the first participant according to the sequence order until reaching the sixth participant, it will be like this. the seventh participant will take the sequence we started with the first participant. this method is commonly used with study design. the sequences is: QVC QCV VQC VCQ CQV CVQ Note: the Q mean listening to Quran, V mean verbal communication, C mean control).

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

the randomization will be achieved according to the order of the sequences in a method known as systematic rotation method with true randomness. there will be six sequences will be written on slips of paper, one sequence per slip and placed in bowel and pulled out in sequence by a person not involved in the study to determine the order of the sequences. after determine the sequences, the first participant who meet to inclusion criteria will be randomly selected by lottery. the next participant will have the next series applied after the series applied to the first participant according to the sequence order until reaching the sixth participant, it will be like this. the seventh participant will take the sequence we started with the first participant. this method is commonly used with study design. the sequences is: QVC QCV VQC VCQ CQV CVQ Note: the Q mean listening to Quran, V mean verbal communication, C mean control).

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：

participants in this trial are unconscious, therefore, participant blinding is inherently ensured as they cannot perceive or distinguish the type of intervention. however, due to the nature of the interventions (headphone-delivered Quran recitation vs. direct verbal communication), blinding of intervention providers and bedside assessors is not feasible. accordingly, the trial will use a single-blind design (analyst-blinded). the statistician will receive de-identified, coded datasets without any indication of group allocation and will remain blinded until completion of the primary analyses. allocation codes will be held by an independent custodian and will only be released after analyses are completed or in case of clinical emergency. bias mitigation measures include standardized outcome forms and the use of objective physiological indicators to support assessment data.

Blinding：

participants in this trial are unconscious, therefore, participant blinding is inherently ensured as they cannot perceive or distinguish the type of intervention. however, due to the nature of the interventions (headphone-delivered Quran recitation vs. direct verbal communication), blinding of intervention providers and bedside assessors is not feasible. accordingly, the trial will use a single-blind design (analyst-blinded). the statistician will receive de-identified, coded datasets without any indication of group allocation and will remain blinded until completion of the primary analyses. allocation codes will be held by an independent custodian and will only be released after analyses are completed or in case of clinical emergency. bias mitigation measures include standardized outcome forms and the use of objective physiological indicators to support assessment data.

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

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）：

no,IPD will not be shared. this decision is based on the necessity to protect the privacy and confidentiality of a vulnerable patient population (ICU patients requiring mechanical ventilation). data sharing would compromise the anonymity and confidentiality guaranteed to participants during the consent process, as institutional resources are not available to fully anonymize and manage external data requests.

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

no,IPD will not be shared. this decision is based on the necessity to protect the privacy and confidentiality of a vulnerable patient population (ICU patients requiring mechanical ventilation). data sharing would compromise the anonymity and confidentiality guaranteed to participants during the consent process, as institutional resources are not available to fully anonymize and manage external data requests.

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 recorded manually on standardized, printed data collection forms for each participant. upon enrollment, each participant is immediately assigned a unique numerical code to ensure anonymity. all subsequent data (BPS, RASS scores, timing) will be recorded exclusively using this code without any personal identifying information. the coded paper data will be entered into dedicated master files created using Microsoft excel.

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

data will be recorded manually on standardized, printed data collection forms for each participant. upon enrollment, each participant is immediately assigned a unique numerical code to ensure anonymity. all subsequent data (BPS, RASS scores, timing) will be recorded exclusively using this code without any personal identifying information. the coded paper data will be entered into dedicated master files created using Microsoft excel.

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：

  2025-12-08 08:52:52