跳至主要内容
临床试验/CTRI/2026/04/108305
CTRI/2026/04/108305尚未招募不适用

A randomized control trial to assess the effects of a preoperative education program on comfort, anxiety and patient–ventilator synchrony among post CTVS surgery patients admitted in the CTVS department at AIIMS, New Delhi.

Shagun Singh1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年8月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1

研究概览

简要总结

This randomized controlled trial aims to evaluate the effectiveness of a structured preoperative education program on comfort, anxiety, and patient–ventilator synchrony among patients undergoing elective cardiothoracic and vascular surgery (CTVS) at AIIMS, New Delhi. Preoperative anxiety and postoperative discomfort are common in cardiac surgery patients and are known to contribute to patient–ventilator asynchrony, prolonged mechanical ventilation, and adverse ICU outcomes. The study seeks to generate evidence to support non-pharmacological, nurse-led interventions that enhance perioperative care.

A quantitative randomized controlled design will be adopted. Adult patients aged 18–60 years scheduled for elective CTVS procedures and expected to require postoperative mechanical ventilation will be enrolled after obtaining informed consent. Eligible participants will be randomly allocated to an intervention group or a control group. The intervention group will receive a structured, nurse-delivered preoperative education program 24–48 hours before surgery, covering the ICU environment, mechanical ventilation, postoperative expectations, coping strategies, and breathing exercises, while the control group will receive routine care. Postoperatively, comfort and anxiety will be assessed using validated self-structured questionnaires, and patient–ventilator synchrony will be evaluated using the asynchrony index. Data will be analyzed using appropriate descriptive and inferential statistics to determine the effectiveness of the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Patients having Age 18-60 years
  • Scheduled for elective cardiac surgery (CABG, valve replacement or repair, combined procedures)
  • Expected to require postoperative mechanical ventilation
  • Ability to understand and communicate in Hindi or English
  • Conscious and oriented (Glasgow Coma Scale score equal to 15)
  • Willingness to participate in the study.

排除标准

  • Age less than 18 or more than 60
  • Emergency or urgent cardiac surgery
  • Documented psychiatric disorders or currently on psychiatric medications
  • Severe cognitive impairment or diagnosed dementia
  • Hearing or visual impairments that preclude participation in education
  • Previous cardiac surgery (redo procedures)
  • Severe preoperative hemodynamic instability requiring inotropic support or intra-aortic balloon pump
  • Illiterate with no family member available to assist
  • Participation in another interventional research study
  • Preoperative mechanical ventilation
  • History of smoking, COPD or other severe comorbidities.

研究者

发起方
Shagun Singh
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Shagun Singh

AIIMS, New Delhi

研究点 (1)

Loading locations...

相似试验

Effects of pre operative education program on... | 临床试验