Effects of Multisensory and Cognitive Interventions Applied in the Intensive Care Unit on Physiological, Psychological and Functional Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Functional Independence Measure (FIM) Total Score
研究概览
简要总结
The goal of this clinical trial is to examine the effects of sensory and cognitive stimulation on physiological, psychological, and functional recovery in adult patients after cardiac surgery who are treated in the intensive care unit (ICU). The main questions it aims to answer are:
- Does sensory and/or cognitive stimulation reduce anxiety and improve hemodynamic stability in ICU patients?
- Does it enhance physical function and independence during early rehabilitation in the ICU?
Researchers will compare four groups:
- Standard care (control),
- Cognitive stimulation,
- Auditory stimulation (music),
- Multisensory stimulation (touch + smell)
to assess which intervention is most effective in improving recovery parameters.
Participants will:
- Be randomly assigned to one of four groups during early mobilization in the ICU
- Receive a 30-minute intervention session depending on group assignment
- Be evaluated for heart rate, blood pressure, oxygen saturation, anxiety (VAS), physical function (PFIT, FIM), and satisfaction before and after the session
详细描述
This randomized controlled trial aims to evaluate the effects of sensory and cognitive stimulation interventions on physiological, psychological, and functional recovery in adult patients who have undergone cardiac surgery and are admitted to the intensive care unit (ICU). Despite early mobilization protocols being widely adopted in ICU settings, the added value of non-pharmacological interventions such as auditory, tactile, olfactory, and cognitive stimulation has not been comprehensively studied in the context of intensive care recovery.
The study addresses the gap in clinical practice regarding multisensory deprivation in ICUs, which can lead to heightened anxiety, delayed functional recovery, and impaired hemodynamic regulation. Previous research has suggested that music therapy, aromatherapy, tactile stimulation, and cognitive exercises may provide benefit individually. However, comparative or combined effects of these modalities remain unexplored in a structured clinical design.
Participants will be randomly assigned to one of four groups: control (standard ICU care), cognitive stimulation, auditory stimulation (music or nature sounds), and multisensory stimulation (lavender or mint aroma combined with tactile stimulation using hand therapy balls). Each intervention will be administered for 30 minutes during the sitting phase of early mobilization.
The primary outcome is improvement in functional independence measured by the Functional Independence Measure (FIM). Secondary outcomes include physiological parameters (heart rate, blood pressure, oxygen saturation, respiratory rate), psychological outcomes (anxiety level assessed by VAS, patient satisfaction), and functional capacity (ICU sitting tolerance, PFIT scores). Assessments will be conducted before, immediately after, and 15 minutes following the intervention to capture both immediate and delayed effects.
The findings of this study are expected to contribute to evidence-based rehabilitation strategies in critical care settings and offer low-cost, non-invasive interventions that can be easily integrated into standard ICU practice to enhance patient comfort and recovery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors are blinded to group allocation. Interventions are administered by a separate team of staff members who are not involved in outcome assessment. Participants are unaware of the specific intervention purpose and content, and standard instructions are used across all groups to minimize expectancy bias. Care providers are not blinded due to the nature of the interventions, but contact with assessors is minimized to maintain blinding integrity.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 80 years
- •Underwent coronary artery bypass grafting (CABG) or other open-heart surgery
- •Admitted to the ICU postoperatively and eligible for early mobilization
- •Hemodynamically stable (within normal blood pressure and heart rate ranges, without inotropic support)
- •Alert and able to communicate
排除标准
- •Diagnosis of ICU delirium or altered mental status
- •Severe hemodynamic instability
- •Presence of neurological disease or significant cognitive impairment
- •Significant sensory deficits (e.g., severe hearing or vision loss)
- •Known allergy or psychological sensitivity to auditory or olfactory stimuli (e.g., aromatherapy or music)
研究组 & 干预措施
Cognitive Stimulation Group
Participants will perform simple cognitive exercises (e.g., word games, attention tasks, problem solving) during a 30-minute sitting session in the ICU.
干预措施: Cognitive Exercises (Behavioral)
Auditory Stimulation Group
Participants will listen to calming music or nature sounds via headphones for 30 minutes during the sitting phase in the ICU.
干预措施: Auditory Stimulation (Behavioral)
Multisensory Stimulation Group
Participants will receive tactile stimulation using hand therapy balls and olfactory stimulation using lavender or mint scent for 30 minutes during the sitting phase in the ICU.
干预措施: Multisensory Stimulation (Behavioral)
Control Group
Participants will receive standard ICU care without any additional cognitive or sensory stimulation during the sitting phase of early mobilization.
结局指标
主要结局
Functional Independence Measure (FIM) Total Score
时间窗: Change in outcome measures from baseline (24 hours post-surgery, prior to intervention), to immediately after intervention (within 1 minute), and at hospital discharge (approximately postoperative Day 5-7).
Functional recovery will be assessed using the Functional Independence Measure (FIM), which comprises 18 items evaluating motor and cognitive functions. Each item is scored on a 7-point scale, yielding a total score ranging from 18 (complete dependence) to 126 (complete independence), with higher scores indicating greater independence.
次要结局
- Oxygen Saturation(SpO₂ values will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.)
- Visual Analog Scale for Anxiety Assessment(Change in outcome measures from baseline (24 hours post-surgery, prior to intervention), to immediately after intervention (within 1 minute), and 15 minutes after intervention)
- Heart Rate(Heart rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.)
- Blood Pressure(Blood pressure will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.)
- Respiratory Rate(Respiratory rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.)
- Patient Satisfaction Score(Immediately after and 15 minutes after intervention)
- Physical Function in Intensive Care Test(Change in outcome measures from baseline (24 hours post-surgery, prior to intervention) to immediately after intervention (within 1 minute))
- Sitting Tolerance Time(During the intervention session)
研究者
Alp Ozel
Assistant Professor
Abant Izzet Baysal University