Effect of Listening to Quran versus Verbal Communication on Pain and Agitation Inducing Suctioning among Intubated Patients: A Randomized Controlled Trial
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 9
- 主要终点
- pain intensity
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- 随机交叉对照
- 盲法
- Single
入排标准
- 年龄范围
- 18 至 —（—）
- 性别
- All
入选标准
- •for this study is:
- •Adult Muslim patients on mechanical ventilation with endotracheal tube.
- •Age 18 years and older.
- •Stable vital signs based on monitor devices.
- •conscious level 5-10 based on Glasgow coma scale.
- •admitted to ICU from 24 hours and more.
- •both sex (male, female).
- •not on contentious deep sedation.
排除标准
- •the exclusion criteria is:
- •patients with brain death or brain damage.
- •conscious level less than 4 based on GCS.
- •hearing impairment or disorder
- •extubated patients.
- •change in type of sedation or dosage less than 2 hours before of intervention.
- •quadriplegia paralysis
- •sedation level 0,-4,-5 based on Richmond agitation-sedation scale.
- •patients with otorrhea & rhinorrhea, and trauma in facial and temporal lobe.
研究组 & 干预措施
Test group
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.
- 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.
- intervention episode B (verbal communication): the patient receives structured verbal reassurance and procedural explanation from the researcher immediately before and during the suctioning process.
- 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.
结局指标
主要结局
pain intensity
时间窗: immediately pre-intervention, during, 5 minute post-intervention
Agitation
时间窗: immediately pre-intervention, during, 5 minute post-intervention
次要结局
- Level of Consciousness(immediately pre-intervention, during, 5 minute post-intervention)
- Vital Signs(immediately pre-intervention, during, 5 minute post-intervention)