The Effects of a Psycho-cognitive Nursing Intervention on Clinical and Psychological Outcomes of Critically Ill Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Pain intensity [10-point numeric rating scale (NRS) scale]
研究概览
简要总结
The purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. The investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.
详细描述
In previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. Investigators will examine whether a Psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes.
Sixty ICU patients with or without SIRS will be randomized to receive either standard care or a brief Psycho-cognitive Nursing Intervention, plus standard care, up to 5 days during ICU stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Critically ill patients
- •Understand Greek language
- •Age over 18 years
- •They have Richmond Agitation Sedation Scale rate: -3 +3
- •Have an Arterial line in place
排除标准
- •Patient who is expected to stay less than 24 hours in Critical care unit
- •Have history of psychiatric disturbances
- •Their condition does not permit use of headphones
- •Have hearing impairment
- •Receive neuro-muscular blockers
- •Are confused
- •Patients under universal conduct precautions
结局指标
主要结局
Change in Pain intensity [10-point numeric rating scale (NRS) scale]
时间窗: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [Behavioral pain scale (BPS) scale]
时间窗: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Pain intensity [critical-care pain observation tool (CPOT) scale]
时间窗: from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).
Change in Systolic blood pressure (SBP)
时间窗: from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in self reported Relaxation/calm levels (self- reported, 10 points NRS scale)
时间窗: from baseline to 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.
Change in Plasma Neuropeptide Y level
时间窗: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide oxytocin level
时间窗: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide beta-endorphin level
时间窗: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Change in Plasma Neuropeptide acetylcholine level
时间窗: from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No]
Investigators will study the differences of clinical and biochemical parameters between randomized groups of patients treated and not treated with the intervention. Differences in levels of neuropeptides and inflammatory markers among patient groups (intervention group and comparison) and group of healthy volunteers.
次要结局
- Change in Diastolic blood pressure (DAP)(from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time), over 1 to 5 days.)
- Change in Mean arterial pressure (MAP)(from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),)
- Change in Heart rate (HR)(from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),)
- Change in Respiration rate (RR)(from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),)
- Change in Temperature (TMP)(from baseline to 30 and 60 min (baseline: just before 1st day starting intervention time),)
- Multiple organ disfunction syndrome (MODS) scores(once on days 1, 3, 5 and on last day of stay in ICU.)
- Change in Self reported anxiety level [10-point numeric rating scale (NRS) scale](from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).)
- Sequential organ failure assessment (SOFA) scores(once on days 1, 3, 5 and on last day of stay in ICU.)
- Change in Self reported fear level [10-point numeric rating scale (NRS)(from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).)
- Change in Self reported optimism level [10-point numeric rating scale (NRS)(from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).)
- Change in Self reported distress level [10-point numeric rating scale (NRS)](from baseline to 60 min over 1-5 days. (baseline: just before 1st day starting intervention time).)
- Richmond agitation-sedation scale (RASS) score(days 1, 2, 3, 4, 5.)
- Change in Plasma levels of Inflammatory marker Interleukin-6(from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No])
- Change in Plasma levels of Inflammatory marker Interleukin-8(from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No])
- Change in Plasma levels of Inflammatory marker soluble fas ligand (sfas)(from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No])
- Change in Plasma inflammatory marker levels High mobility group box-1 (HMGB-1)](from baseline to 60 min (baseline: morning before 1st day intervention) (1st sample), morning after 1st day intervention (2nd sample), morning before and after intervention (1st and 2nd sample) on days 3rd and 5th.] [Designated as safety issue: No])
- Self reported quality of Sleep [10-point numeric rating scale (NRS) scale](morning before starting intervention (days 1-5))
- assessment of psychological distress (ICUESS: Intensive Care Unit Environmental Stressor Scale, self-assessment in a 1-10 numerical analogue scale).(within 48 hours post discharge from ICU)
- Assessment of symptoms of post traumatic stress disorder (PTSD) using DTS (Davidson Trauma Scale)(one month and six months after hospital discharge)
- assessment of quality of life using Short Form 36 version2 scale (SF36v2)(one month and six months after discharge)
- Exploration of lived experience of critical illness (phenomenological interviews)(one month and six months after discharge)
研究者
Dr Elizabeth Papathanassoglou
Professor
Cyprus University of Technology