Coronary Artery Bypass Graft (CABG)MICU-CARENCT07116941
Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery
A study testing Cognitive Exercises, Auditory Stimulation and Multisensory Stimulation in people with Coronary Artery Bypass Graft (CABG) and Cardiac Surgery Subjects, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Coronary Artery Bypass Graft (CABG), Cardiac Surgery Subjects, Postoperative Care
- What is being tested?
- Cognitive Exercises, Auditory Stimulation and Multisensory Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2025to 13 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital
Bolu, 14030
About this study
Official title: Effects of Multisensory and Cognitive Interventions Applied in the Intensive Care Unit on Physiological, Psychological and Functional Outcomes
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?
Read more
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
Read the detailed description
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.
- Being tested
- Cognitive Exercises, Auditory Stimulation, Multisensory Stimulation
- Keywords
- Early Mobilization, Intensive Care Unit, Cardiac Surgery, Multisensory Intervention, Anxiety, Non-pharmacological Intervention, Rehabilitation in ICU
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive ExercisesBehavioural
Participants 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 StimulationBehavioural
Participants 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 StimulationBehavioural
Participants 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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | Participants will receive standard ICU care without any additional cognitive or sensory stimulation during the sitting phase of early mobilization. |
| Cognitive Stimulation Group | Experimental | Participants will perform simple cognitive exercises (e.g., word games, attention tasks, problem solving) during a 30-minute sitting session in the ICU. Receives: Behavioral: Cognitive Exercises |
| Auditory Stimulation Group | Experimental | Participants will listen to calming music or nature sounds via headphones for 30 minutes during the sitting phase in the ICU. Receives: Behavioral: Auditory Stimulation |
| Multisensory Stimulation Group | Experimental | 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. Receives: Behavioral: Multisensory Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (8)
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.
Measured: 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 (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.
Measured: 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 (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.
Measured: 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 (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.
Measured: Respiratory rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Oxygen Saturation
Oxygen saturation (SpO₂, %) will be measured to assess peripheral oxygenation status in response to the intervention. Measurements will be obtained using a standard pulse oximeter while the participant is in a seated resting position. igher values indicate better oxygenation, while decreases may reflect impaired respiratory function or increased physiological demand. A change greater than 4 percentage points will be considered clinically significant.
Measured: SpO₂ values will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Patient Satisfaction Score
Satisfaction will be assessed using a 5-item questionnaire, with each item rated from 1 (strongly disagree) to 5 (strongly agree). The mean score will be calculated.
Measured: Immediately after and 15 minutes after intervention
Physical Function in Intensive Care Test
The Physical Function in Intensive Care Test (PFIT) is a performance-based measure used to assess physical function in critically ill patients. It evaluates four components: sit-to-stand assistance, marching on the spot (cadence), shoulder (or quadriceps) strength, and duration of marching. Each component is scored and combined into a total PFIT score ranging from 0 to 12. Higher scores indicate better physical function and greater mobility capacity.
Measured: Change in outcome measures from baseline (24 hours post-surgery, prior to intervention) to immediately after intervention (within 1 minute)
Sitting Tolerance Time
Duration (in minutes and seconds) that participants can maintain a seated position will be recorded. Criteria include hemodynamic stability and subjective tolerance (e.g., dizziness, fatigue).
Measured: During the intervention session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start1 Aug 2025
- Primary completion13 Aug 2026
- Study completion13 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Bypass Graft (CABG)Studies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a prospective, randomized, controlled, parallel-group clinical trial with four arms. Participants are randomly assigned to one of the following groups: control (standard ICU care), cognitive stimulation, auditory stimulation, or multisensory stimulation. Each participant receives a single type of intervention without crossover. Interventions are delivered during the early mobilization (sitting) phase in the ICU. Randomization is performed using a computer-generated allocation sequence, and outcome assessors are blinded to group assignments.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alp Ozel, Abant Izzet Baysal University
- Investigators
- Alp Ozel, PT, PhD, Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07116941
- Sponsor's protocol ID
- AIBU-FTR-AO-04
- Acronym
- MICU-CARE
- Status last verified
- Aug 2026
- First submitted
- 25 Jul 2025
- Last updated
- 17 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. The data will be made publicly available at the time of publication via the Zenodo online repository (https://zenodo.org).
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multisensory and Cognitive Interventions Applied in the Intensive Care Unit on Physiological, Psychological and Functional Outcomes
- ClinicalTrials.gov ID
- NCT07116941
- Acronym / sponsor ID
- MICU-CARE / AIBU-FTR-AO-04
- Keywords
- Early Mobilization, Intensive Care Unit, Cardiac Surgery, Multisensory Intervention, Anxiety, Non-pharmacological Intervention, Rehabilitation in ICU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 13 Aug 2026 (actual)
- Study completion
- 13 Aug 2026 (actual)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
- Model description
- This study is a prospective, randomized, controlled, parallel-group clinical trial with four arms. Participants are randomly assigned to one of the following groups: control (standard ICU care), cognitive stimulation, auditory stimulation, or multisensory stimulation. Each participant receives a single type of intervention without crossover. Interventions are delivered during the early mobilization (sitting) phase in the ICU. Randomization is performed using a computer-generated allocation sequence, and outcome assessors are blinded to group assignments.
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Participants will receive standard ICU care without any additional cognitive or sensory stimulation during the sitting phase of early mobilization. |
| Cognitive Stimulation Group | Experimental | Behavioral: Cognitive ExercisesParticipants will perform simple cognitive exercises (e.g., word games, attention tasks, problem solving) during a 30-minute sitting session in the ICU. |
| Auditory Stimulation Group | Experimental | Behavioral: Auditory StimulationParticipants will listen to calming music or nature sounds via headphones for 30 minutes during the sitting phase in the ICU. |
| Multisensory Stimulation Group | Experimental | Behavioral: Multisensory StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive ExercisesParticipants 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. | Behavioural | Cognitive Stimulation Group |
| Auditory StimulationParticipants 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. | Behavioural | Auditory Stimulation Group |
| Multisensory StimulationParticipants 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. | Behavioural | Multisensory Stimulation Group |
Primary outcome
Functional Independence Measure (FIM) Total Score
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).
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.
8 secondary outcomes
Visual Analog Scale for Anxiety Assessment
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 intervention
Heart Rate
Time frame: Heart rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Blood Pressure
Time frame: Blood pressure will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Respiratory Rate
Time frame: Respiratory rate will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Oxygen Saturation
Time frame: SpO₂ values will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.
Patient Satisfaction Score
Time frame: Immediately after and 15 minutes after intervention
Physical Function in Intensive Care Test
Time frame: Change in outcome measures from baseline (24 hours post-surgery, prior to intervention) to immediately after intervention (within 1 minute)
Sitting Tolerance Time
Time frame: During the intervention session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: Yes. Individual participant data (IPD) that underlie the results reported in this study will be shared after de-identification. The data will be made publicly available at the time of publication via the Zenodo online repository (https://zenodo.org).
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Coronary Artery Bypass Graft (CABG)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alp Ozel, PT, PhD principal investigator
Abant Izzet Baysal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Exercises, Auditory Stimulation and Multisensory Stimulation in people with Coronary Artery Bypass Graft (CABG) and Cardiac Surgery Subjects, run by Abant Izzet Baysal University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (FIM) Total Score (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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2026.