跳至主要内容
临床试验/NCT07812376
NCT07812376尚未招募不适用

Effectiveness of a Stress Management Training Program in Reducing Caregiver Burden and Perceived Stress Among Families of Long-Stay ICU Patients

Al-Balqa Applied University0 个研究点目标入组 50 人开始时间: 2026年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
主要终点
Perceived Stress Score

研究概览

简要总结

This research helps to close an important gap in the provision of care to ICU families and introduces a structured and accessible psychological intervention to family caregivers of long-stay ICU patients. The findings are expected to contribute to the integration of stress management training in family-centered nursing practices and contribute to improved psychological well-being of the caregivers of families in intensive care settings.

详细描述

Admission to intensive care unit (ICU) is a very stressful event to the patient and his family members. Family caregivers of critically ill patients are confronted with constant uncertainty, fear of negative outcomes of care, unfamiliar environments, and a minimal participation in care, which makes them extremely vulnerable to developing psychological distress (Checa-Checa et al., 2025). This distress is often made worse when going through long serving time in ICU, especially when the patients are not able to communicate and be taken part in the decision-making process.

Family caregivers play a central role during the ICU hospitalization in terms of offering emotional support, attending the decision-making process, and offering a constant presence at the bedside. These responsibilities are often associated with neglect of the physical as well as psychological requirements of the caregivers. Evidence from hospital and critical care settings suggests that caregivers are exposed to high levels of stress and of emotional exhaustion, sleep disturbances and disruption to daily functioning (Abuatiq et al., 2020; McIlvennan et al., 2021). Over time these stressors may yield caregiver burden (a multidimensional phenomenon which may involve physical, emotional, social and psychological strains).

High levels of caregiver burden and perceived stress have been documented among multiple different populations of caregivers, including caregivers of patients with chronic and life-threatening conditions. Studies involving either family caregivers of patients undergoing hemodialysis, living with heart failure or recovering from stroke all report moderate to severe caregiver burden with high levels of perceived stress and negative emotions outcomes (Shaykh et al., 2023; Khouban-Shargh et al., 2024; Liu et al., 2025). These findings have a very relevant application in ICU, where the level of care, uncertainty about prognosis and very long stay cause further jeopardy among caregivers.

Perceived stress represents people's appreciation of situations as unpredictable, uncontrollable, and overwhelming. Among caregivers in the family setting, the high perceived stress levels have been linked to poor preparedness for caregiving positions, emotional stress, and lessened ability to cope (McIlvennan et al., 2021). Stressors like awaiting results of test results, fearing patient deterioration, sleep deprivation, monetary concerns, and lack of information access are common in ICU and hospital settings (Abuatiq et al, 2020; Krampe et al, 2021) according to caregivers.

Stress management interventions attempt to increase adaptive coping by increasing the ability to manage stress through better awareness of stress, the way we think about things, the way we manage emotions, and how well we are able to solve problems. Evidence from caring populations suggest that the implementation of structured stress management training programs was able to lower the burden on caregivers and perceived stress and also increase psychological well-being (Shaykh et al., 2023; Liu et al., 2025). In the critical care, interventions led by nurses and psychosocial healthcare have been linked to lessened psychological distress and better emotional outcomes among family members (Checa-Checa et al., 2025; Watland et al., 2025). However, many of the ICU interventions focus mainly on information provision and decision-making support, and may not place much emphasis on structured stress management training.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18 years or older.
  • Identified as the primary caregiver or main family companion of a patient admitted to the ICU.
  • The patient has had an ICU stay of more than 10 consecutive days.
  • Able to communicate verbally and complete the study questionnaires.
  • Have access to a smartphone, tablet, computer, or other digital device with internet access to participate in the training sessions.
  • Willing and able to provide written informed consent to participate in the study

排除标准

  • A history of a psychiatric disorder that substantially impairs their ability to understand the study procedures, communicate effectively, or complete the study questionnaires reliably.

研究组 & 干预措施

interventional group

Experimental

Stress Management Training Program

干预措施: Stress Management Training Program (Behavioral)

control group

No Intervention

no interventions

结局指标

主要结局

Perceived Stress Score

时间窗: 6 weeks

Perceived stress will be assessed using the 14-item Perceived Stress Scale (PSS-14). The PSS assesses the level of perceived stress experienced over the previous month. The PSS is available in three versions, including the PSS-14. Each item is rated on a 5-point Likert scale from 0 (never) to 4 (very often). After reverse-scoring the positively worded items, the item scores are summed to produce a total score ranging from 0 to 56. Higher total scores indicate greater perceived stress. The unit of measure is the total PSS-14 score (0-56).

Caregiver Burden as Measured by the 12-Item Zarit Burden Interview (ZBI-12)

时间窗: 6 weeks

Caregiver burden will be assessed using the 12-item Zarit Burden Interview (ZBI-12). The ZBI-12 consists of 12 items rated on a 5-point Likert scale from 0 (never) to 4 (nearly always), with a total score ranging from 0 to 48. Higher total scores indicate greater perceived caregiver burden. The unit of measure is the total ZBI-12 score (0-48).

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mutaz Fuad Ghleb Alradaydeh

Assistant Professor at Al-Balqa Applied University

Al-Balqa Applied University

相似试验