A randomized controlled trial to assess the effectiveness of Sensation Awareness Focused Training (SAFT) on symptoms of Post Intensive Care Syndrome-Family(PICS-F) among the attendants of patients admitted in ICU in a selected tertiary care hospital from eastern India.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 76
- 试验地点
- 1
研究概览
简要总结
This randomized controlled trial aims to examine the effectiveness of Sensation Awareness Focused Training (SAFT), a structured awareness-based intervention, on symptoms of Post Intensive Care Syndrome Family (PICS-F) among family members of patients admitted to the Intensive Care Unit. The study will compare family members receiving SAFT for three consecutive days with those receiving standard care. The primary hypothesis is that SAFT will significantly reduce psychological symptoms including anxiety, depression, post-traumatic stress, and complicated grief in family members. Secondary objectives include examining associations between demographic and clinical variables and PICS-F symptom severity, exploring interrelationships among PICS-F symptom domains, and evaluating correlations between individual PICS-F symptoms. Assessments will be conducted at baseline, Day 3 post-intervention, and Day 15 follow-up.
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 70.00 Year(s)（—）
- 性别
- All
入选标准
- •INCLUSION CRITERIA For Family Members: Adult aged eighteen years or above Identified as the primary family member or primary decision-maker for an adult patient currently admitted to the ICU Patient expected to remain in ICU for at least forty-eight hours at time of enrolment (allowing sufficient time to deliver the intervention) Able to speak and read Bengali or Hindi, or English sufficiently to complete outcome measures Willing and able to provide informed consent Available to receive intervention sessions for 3 days during patient’s ICU stay Able to be contacted for follow-up assessments at 3rd and 15th day.
- •For Patients Admitted to adult ICU (age eighteen years or above) Expected ICU length of stay of at least forty-eight hours based on clinical assessment Presence of identifiable primary family member meeting eligibility criteria.
排除标准
- •For Family Members: Family member with diagnosed severe mental illness (schizophrenia, bipolar disorder, current major depressive episode) that would preclude participation or require specialized mental health care beyond the scope of the intervention Family member actively receiving psychotherapy or psychiatric treatment for anxiety, depression, or PTSD at time of enrolment Family member with visual impairment and neurological condition that would prevent ability to follow facilitator’s hand movements during SAFT Family member who is healthcare professional working in ICU setting (to avoid potential confounding due to professional knowledge and experience) Patient expected to be brain-dead or undergoing determination of death protocols (as family experience differs qualitatively) Patient admitted primarily for palliative care or comfort measures only at time of enrolment For Patients Expected ICU length of stay less than forty-eight hours No identifiable primary family member available Readmission to ICU during same hospitalization if family member was previously enrolled.
研究者
DIPANWITA PAL
All India Institute Of Medical Sciences, Kalyani