Effectiveness of brief Mindfulness Based Interventions (MBIs) on improving Perceived Stress among caregivers of patients in Intensive Care Settings.
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
- Change in Perceived Stress Scale (PSS) and Hospital Anxiety and Depression Scale (HADS) scores.
研究概览
简要总结
This study aims to understand the effect of brief Mindfulness Based Interventions (MBIs) on perceived stress, anxiety and depression among family caregivers/caretakers of patients in the Intensive Care Settings including ICUs and HDUs.
Participants in the age group of 18 - 65 year old of any gender will be included in the study. Family caretakers suffering from known psychiatric illness, substance abuse (except nicotine and tobacco), and less than 3 days of assumed hospital stay will be excluded from the study.
Upon taking written informed consent the participants will be recruited and randomly allotted to case arm or control arm.
The Perceived Stress Scale (PSS) and Hospital Anxiety and Depression scale (HADS) will be used to assess the effectiveness of MBIs on improving perceived stress, anxiety and depression among the caregivers as the primary objective. Biochemical markers of stress, i.e., Salivary Cortisol (SCort) and Salivary Alpha Amylase (SAA) will be assessed for pre-intervention and post-intervention levels to gauge physiological response of intervention on stress along with Feasibility and Acceptability of Intervention Measure (FIM and AIM) will be administered to both arms as the secondary objective.
Further data analysis will be done using standard SPSS software and biochemical analysis will be done using ELISA technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Age of caregiver of patients in Intensive Care Setups (ICUs and HDUs) between 18 to 65 years old.
- •Any gender.
排除标准
- •Psychiatric illness, Substance abuse (except tobacco), no written consent and hospital stay less than 3 days.
结局指标
主要结局
Change in Perceived Stress Scale (PSS) and Hospital Anxiety and Depression Scale (HADS) scores.
时间窗: The scales are administered thrice, i.e., pre-intervention (DAY 0), mid-intervention (DAY 3), and post-intervention (DAY 6).
次要结局
- Salivary Cortisol and Salivary Alpha Amylase Levels.(The samples will be measured twice, i.e., pre-interventional (DAY 0) and post-interventional (DAY6))
- Accessibility of Intervention Measure (AIM) and Feasibility of Intervention Measure (FIM)(This will be done twice, i.e., mid-interventional (DAY 3) and post-interventional (DAY 6))
研究者
Dr Jigyansa Ipsita Pattnaik
Kalinga Institute of Medical Sciences, Bhubaneswar. Odisha