ChiCTR2500114074
尚未开始
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2025-12-08
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Effect of Listening to Quran versus Verbal Communication on Respiratory Suctioning-Induced Pain and Agitation among Intubated Patients: A Randomized Controlled Trail
Effect of Listening to Quran versus Verbal Communication on Pain and Agitation Inducing Suctioning among Intubated Patients: A Randomized Controlled Trial
10047
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.
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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).
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.
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2025-12-09
2025-12-10
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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.；
请登录查看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.；
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10047
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