Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAbant Izzet Baysal University
About this trial
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:
1. Standard care (control), 2. Cognitive stimulation, 3. Auditory stimulation (music), 4. 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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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)
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive Exercises
BehavioralParticipants perform a 30-minute session of cognitive tasks during the sitting phase of early ICU mobilization. Activities include word games, attention exercises, and simple problem-solving tasks designed to engage memory and executive function.
Auditory Stimulation
BehavioralParticipants listen to calming music or nature sounds through headphones for 30 minutes during early mobilization in the ICU. The auditory content is selected to reduce anxiety and promote relaxation.
Multisensory Stimulation
BehavioralParticipants receive 30 minutes of combined sensory stimulation during the sitting phase in the ICU. This includes tactile stimulation using hand therapy balls and olfactory stimulation with lavender or mint-scented materials to enhance relaxation and sensory engagement.
Treatment groups
125 Participants
are divided into 4 treatment groupsGroup A: Control GroupNo intervention 0 interventions
Group B: Cognitive Stimulation GroupExperimental treatment 1 intervention
Group C: Auditory Stimulation GroupExperimental treatment 1 intervention
Group D: Multisensory Stimulation GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Functional Independence Measure (FIM) Total Score
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.
Time frame
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).Secondary outcomes
1
Visual Analog Scale for Anxiety Assessment
Anxiety will be assessed using the Visual Analog Scale (VAS), which consists of a 10-centimeter horizontal line anchored with "no anxiety" (score = 0) on the left end and "worst imaginable anxiety" (score = 10) on the right end. Patients will be instructed to place a mark on the line that best represents the intensity of their current anxiety. The score will be determined by measuring the distance in centimeters from the left end of the line to the point marked by the patient. Higher scores indicate greater levels of anxiety.
Time frame
Change in outcome measures from baseline (24 hours post-surgery, prior to intervention), to immediately after intervention (within 1 minute), and 15 minutes after intervention2
Heart Rate
Heart rate (beats per minute, bpm) will be measured to assess the autonomic physiological response to the intervention. Measurements will be performed using a standard bedside patient monitor while the participant is in a seated resting position. Changes in heart rate may reflect autonomic activation or relaxation in response to the intervention.
Time frame
Heart rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.3
Blood Pressure
Blood pressure (systolic and diastolic, mmHg) will be measured to evaluate the cardiovascular response to the intervention. Measurements will be obtained using a calibrated automatic sphygmomanometer while the participant is in a seated resting position, with the arm supported at heart level. Variations in systolic and/or diastolic values may indicate hemodynamic responses related to stress or relaxation.
Time frame
Blood pressure will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.4
Respiratory Rate
Respiratory rate (breaths per minute) will be measured to assess the respiratory response to the intervention. Measurements will be performed using a standard bedside patient monitor while the participant is in a seated resting position. An increase or decrease in respiratory rate may reflect physiological arousal or relaxation in response to the intervention.
Time frame
Respiratory rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.Sponsors and contacts
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Source ClinicalTrials.gov