【ChiCTR2500114074】Effect of Listening to Quran versus Verbal Communication on Respiratory Suctioning-Induced Pain and Agitation among Intubated Patients: A Randomized Controlled Trail

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基本信息

登记号

ChiCTR2500114074

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2025-12-08

临床申请受理号

靶点

适应症

试验通俗题目

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

试验专业题目

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

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

10047

联系人通讯地址

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临床试验信息

试验目的

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.

试验分类

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试验类型

随机交叉对照

试验分期

其它

随机化

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).

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.

试验项目经费来源

试验范围

目标入组人数

实际入组人数

第一例入组时间

2025-12-09

试验终止时间

2025-12-10

是否属于一致性

入选标准

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.；

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.；

研究者信息

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试验机构

University of Baghdad

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研究负责人邮箱

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研究负责人邮编

10047

联系人通讯地址