Multisensory and Cognitive Interventions in the ICU: Effects on Health and Recovery

NCT07116941 | Recruiting

• 1 other identifier: AIBU-FTR-AO-04
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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). 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)
• 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

Conditions

Coronary Artery Bypass Graft (CABG); Cardiac Surgery Subjects; Postoperative Care

Keywords

Early Mobilization; Intensive Care Unit; Cardiac Surgery; Multisensory Intervention; Anxiety; Non-pharmacological Intervention; Rehabilitation in ICU

Outcome Measures

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.

  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

  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.

• Oxygen Saturation

  SpO₂ values will be recorded at three time points: before the intervention, immediately after the session, and 15 minutes post-intervention.

Study Arms (4)

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.

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.

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.

Behavioral: Multisensory Stimulation

Interventions

Cognitive Exercises BEHAVIORAL

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.

Cognitive Stimulation Group

Auditory Stimulation BEHAVIORAL

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.

Auditory Stimulation Group

Multisensory Stimulation BEHAVIORAL

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.

Multisensory Stimulation Group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Abant Izzet Baysal University: lead

Study Sites (1)

Bolu Abant Izzet Baysal University, Izzet Baysal Training and Research Hospital

Bolu, 14030, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Acoustic Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Sensory Art Therapies; Complementary Therapies; Physical Stimulation; Investigative Techniques

Study Officials

• Alp Ozel, PT, PhD

  Abant Izzet Baysal University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alp Ozel, PT, PhD

CONTACT

+903742534520; alpozel@ibu.edu.tr

Umut A Ugras, MD

CONTACT

+905066434435; umutataugras@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: July 25, 2025
• First Posted: August 12, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: IPD and supporting documents will be available starting at the time of publication and will remain indefinitely accessible via the Zenodo repository (https://zenodo.org).
• Access Criteria: The individual participant data (IPD) and supporting documents (including the study protocol, statistical analysis plan, and analytic code) will be publicly accessible to anyone via the Zenodo repository (https://zenodo.org) without restriction.

Locations

TU (1)