Physiological and Psychological effects of guided meditation in critically ill patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Subset 1 & 2:Effect of guided meditation on heart rate variability
研究概览
简要总结
Critically ill patients undergo a significant amount of environmental and psycho-physical stress. Indeed, not only is their severe and debilitating underlying clinical condition stressful, but they also are subject to a wide array of stressors, related to the environment in which they are cared and to the procedures to which they undergo, which all have been associated with significant discomfort. Anxiety is a common finding in hospitalized patients, and even more in those who are critically ill. It was suggested that up to 80% of patients in the ICU may suffer from anxiety, especially in those undergoing mechanical ventilation.
The categories of long-term effects of sepsis include immune-metabolic, neurocognitive, psychiatric, and physical derangements. These effects lead to increased mortality and severely worsened health-related quality of life. Health care professionals and family members pay a heavy cost—in both money and energy—in caring for these patients with sizable health issues. The current goals of care for patients who survive sepsis include approaches that are effective in early sepsis, controlling pain, agitation, and delirium, and early mobilization. However, there is an unmet need of developing efficient therapeutic strategies specifically tailored towards sepsis survivors. While the administration of drugs plays an undoubtful role in the management of ICU-related stress, there are a variety of non-pharmacologic interventions and protocols, that have shown to be able to effectively prevent and treat various manifestations of ICU stay.
Various relaxation interventions have been shown to reduce stress, anxiety and pain level, bring about parasympathetic shift in heart rate variability and promoting relaxation in different cohorts of healthy individuals and those suffering from various diseases. However, there is dearth of studies in this area.
Present study aims to analyze physiological and psychological effects of guided meditation on critically ill patients::Subset 1: Conscious, critically ill obstetric patients, Subset 2: Unconscious patients of Traumatic brain Injury
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Subset 1__ Physiological and Psychological effects of guided meditation in critically ill obstetric patients_Inclusion Criteria_Critically ill conscious obstetric patients (antenatal/postnatal) who are not on mechanical ventilation.
- •Subset 2_Physiological and Psychological effects of guided meditation in critically ill traumatic brain injury patients who are on mechanical ventilation.Inclusion Criteria_Critically ill traumatic brain injury patients (on medical management/ post operative patients) who are on mechanical ventilation.
排除标准
- •Subset 1_Exclusion Criteria 1.Hemodynamically unstable patients.
- •2.Patients having any psychiatric disease 3.Patients whose condition gets changed to other category due to course of illness (e.g. those who worsen and require ventilation, etc) 4.Patients with altered mental status.
- •5.Patients having cardiac arrythmias.
- •6.Patients would be excluded from the experiment in the event of death, transferring to other medical centers or discharge, the need for emergency surgery during the study.
- •Subset_2:1.Hemodynamically unstable patients.
- •2.Patients on N-M blockage drugs 3.Patients having any psychiatric disease 4.Likely survival of less than 3 days 5.Patients whose condition gets changed to other category due to course of illness (e.g. those who improved and extubated, etc) 6.Patients would be excluded from the experiment in the event of death, transferring to other medical centers or discharge, the need for emergency surgery during the study.
结局指标
主要结局
Subset 1 & 2:Effect of guided meditation on heart rate variability
时间窗: Before and after each guided meditation session on all 3 days
次要结局
- Subset_1_Effect of guided meditation on anxiety and wellbeing as measured by visual analogue scale, Effect of guided meditation on physiological parameters, viz. Heart rate, Blood pressure, SpO2, Respiratory rate(Subset_2_Effect of guided meditation on sedative requirement,effect of guided meditation on opioid requirement,Effect of guided meditation on physiological parameters, viz., Heart rate, Blood pressure, SpO2, Respiratory rate.)