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临床试验/CTRI/2024/06/069609
CTRI/2024/06/069609尚未招募2 期

A comparative study on flexible visiting policy with specific communication protocol Vs restrictive visiting policy on incidence of delirium among patients admitted in ICUs and their caregiver satisfaction in PGIMER Chandigarh 2023 2025

Anjali Singh1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年7月8日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
100
试验地点
1
主要终点
Incidence of delirium

研究概览

简要总结

ICU patients who experience delirium, face a substantial risk of consequences, including prolonged hospital stays in the ICU, a sluggish recovery, a high death rate, and eventually an overburdening of the healthcare system .Delirium is a substantial problem in critically ill patients. Involvement of caregiver in care and allowing them for 24 hours near their patient as in  flexible visiting policy there is reduced incidence of delirium in ICU patients, without increasing the risks of nosocomial infection or mortality. But still maximum ICUs are having restrictive visiting policy**.** Since there are currently no noteworthy randomized trials examining the effects of flexible family visiting rules on patients, family members, and ICU staff, it may be challenging to decide how to implement ICU visiting policies most effectively**.**Hence the aim of this study is to explore the effect of “flexible visiting policy with specific communication protocol on incidence of delirium among patients admitted in ICUs and their caregiver satisfaction  and compare it with restrictive visiting policy of ICU.

H0 (1): There is no significant difference in the incidence of delirium among patients admitted in ICUs  with flexible visiting policy with specific communication protocol and restrictive visiting policy.

H0 (2): There is no significant difference between flexible visiting policy with specific communication protocol and restrictive visiting policy on caregiver’s satisfaction

Ha (1): Flexible visiting policy with specific communication protocol will reduce the incidence of delirium among patients admitted in ICUs.

Ha (2): Flexible visiting policy with specific communication protocol will improve caregiver’s satisfaction.

Ha (3): Flexible visiting policy with specific communication protocol will decrease in the length of ICU stay.

Ha (4): Flexible visiting policy with specific communication protocol will not increase hospital acquired infection in patients admitted in ICUs.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

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

入选标准

  • ICU stay of more than 48 hours with family member as caregiver.

排除标准

  • Delirium at base line APACHE II score more than 35 RASS -4 or -5 for more than 96 hours.

结局指标

主要结局

Incidence of delirium

时间窗: 3 months

Caregiver satisfaction

时间窗: 3 months

Nurse perspective on visiting policy

时间窗: 3 months

次要结局

  • Length of ICU stay(Nosocomial Infection)

研究者

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

Anjali Singh

National Institute of Nursing Education, Post-Graduate Institute of Medical Education and Research

研究点 (1)

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