Evaluation of anxiety using faces anxiety scale in ICU patients using noise ablating headphones during night time versus ICU patients receiving usual care.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups.
研究概览
简要总结
The Intensive care Unit is one of the most stressful environments for people among various clinical settings in hospital. ICU patients are not only compromised by illness but are also faced wide variety of stressors such as experience of pain, unfamiliar environment, insomnia, fear, threat of death and loss of interaction with family members and friends. Increased Stress activate sympathetic nervous system manifested by increased heart rate, blood pressure and respiratory rate. ICU environment in itself is one of the major causes of anxiety in patients which further increases their stay there. To evaluate the anxiety we are using Faces Anxiety Scale which is considered as valid measure of anxiety( the study from American journel of Critical Care).
Aim: To evaluate whether reduction of stressful ICU noise during night time has some effect on patient’s anxiety levels over the course of their stay in ICU using nose ablating headphones.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 11.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Eligible patients are any patients in ICU who could interact even intermittently in order to respond to questions about their feelings and emotions , opened their eyes in response to hearing their name or spontaneously or are awake , understand Hindi and have sufficient corrected vision to see Faces scale.
- •These patients must be admitted in ICU for atleast 48 hours.
排除标准
- •Patients having: a)severe to profound hearing loss.
- •b)head or oromaxillofacial trauma.
- •c)Baseline use of hearing aids.
- •d)any other contradiction to use of ear plugs or headphones.
结局指标
主要结局
Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups.
时间窗: Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups. | receiving usual care ( control group) | Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge. | In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale. | Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
receiving usual care ( control group)
时间窗: Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups. | receiving usual care ( control group) | Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge. | In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale. | Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge.
时间窗: Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups. | receiving usual care ( control group) | Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge. | In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale. | Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale.
时间窗: Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups. | receiving usual care ( control group) | Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge. | In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale. | Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
时间窗: Study seeks to examine the effects of overnight noise reduction in ICU patients. Subjects will randomly be placed in two groups. | receiving usual care ( control group) | Standard nose ablating headphones applied from 11pm to 6am nightly for atleast four nights or until ICU discharge. | In morning patients will be asked to grade their anxiety as shown in Faces Anxiety Scale. | Assessment will be done for four days of their stay in ICU or until they are transfered to their respective wards.
次要结局
- Secondary: Effect on the requirement of sedatives in ICU during the course of their stay.