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临床试验/CTRI/2024/04/066532
CTRI/2024/04/066532
招募中
2 期

Efficacy of Communication APP (C-APP) on ease of communication and patient satisfaction among patients with mechanical ventilation in ICUs at a tertiary care center - A Randomized Controlled Trial

未提供1 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2024年5月15日最近更新:

概览

阶段
2 期
状态
招募中
入组人数
140
试验地点
1
主要终点
1.Ease of Communication

概览

简要总结

The Efficacy of Communication APP on ease of communication and patient satisfaction among patients with mechanical ventilation in Intensive care units at a tertiary care center is being investigated through a Randomized Controlled Trial

The objective of this trial is to assess the efficacy of Communication APP in improving ease of communication and patient satisfaction among ICU patients undergoing mechanical ventilation

Patients will be  randomized into experimental and control groups with the experimental group receiving Communication APP alongside routine aids while the control group receives routine aids only

Data collection involves screening patients based on various scales such as the Glasgow Coma Scale and Richmond Agitation Sedation Scale

Baseline assessment includes evaluating ease of communication and physiological parameters like heart rate and blood pressure

During the intervention period a minimum of 10 communication exchanges are facilitated using Communication APP or routine aids

Post-test evaluation occurs 2 to 48 hours post extubation or tracheostomy that includes assessing ease of communication and patient satisfaction

Continuous physiological monitoring of vital signs is conducted before then during and after each communication exchange

Primary outcomes focus on communication ease and patient satisfaction with secondary outcomes examining physiological responses

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients of age above 18 years.
  • Both male and female patients Patients who are alert, conscious, stable, and attempting to communicate.
  • Patients on mechanical ventilator (day 3 to 2 weeks) Patients who are willing to participate Patients who can read/write/understand English/Tamil.

排除标准

  • Patients with dementia, delirium, psychiatric disorders Patients who have difficulty to understand and follow instructions.
  • Patients whose condition is hemodynamically unstable Patients with severe hearing, visual which cannot be corrected with aids.
  • Patients with preexisting communication impairment such as conditions affecting speech articulation, language comprehension, or expression, including aphasia, dysarthria, or language disorders.
  • Patients on paralytic drugs.
  • Patients on CMV(Continuous Mandatory Ventilation) Mode.

结局指标

主要结局

1.Ease of Communication

时间窗: 1.Ease of communication | Baseline/Pretest:Assessment will be conducted on day 3 of mechanical ventilation after randomization. | Post test: Assessments will be conducted daily from day 4 upto day 10 of mechanical ventilation according to duration of ventilation,example patient on ventilation for 10 days post test will be done on day 4, day 5, day 6, day 7, day 8, day 9, and day 10. | 2. Patient Satisfaction (Post test only)This assessment will be done on day 1 or 2 after extubation/tracheostomy.

2.Patient satisfaction about Communication Aid

时间窗: 1.Ease of communication | Baseline/Pretest:Assessment will be conducted on day 3 of mechanical ventilation after randomization. | Post test: Assessments will be conducted daily from day 4 upto day 10 of mechanical ventilation according to duration of ventilation,example patient on ventilation for 10 days post test will be done on day 4, day 5, day 6, day 7, day 8, day 9, and day 10. | 2. Patient Satisfaction (Post test only)This assessment will be done on day 1 or 2 after extubation/tracheostomy.

次要结局

  • 1.Physiological Parameters(Heart rate,Blood Pressure,Respiratory Rate,ECG and Oxygen Saturation)

研究者

发起方
未提供
责任方
Principal Investigator
主要研究者

ANNAPOORANI M

SRM College of Nursing,Faculty of Medical & Health Sciences ,SRMIST.

研究点 (1)

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