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

NCT ID: NCT07116941

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-01
• Study Completion Date: 2025-12-31

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:

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Control Group

Participants will receive standard ICU care without any additional cognitive or sensory stimulation during the sitting phase of early mobilization.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Cognitive Exercises

Intervention Type: 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.

Auditory Stimulation Group

Participants will listen to calming music or nature sounds via headphones for 30 minutes during the sitting phase in the ICU.

Group Type: EXPERIMENTAL

Auditory Stimulation

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Multisensory Stimulation

Intervention Type: 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.

Interventions

Cognitive Exercises

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.

Intervention Type: BEHAVIORAL

Auditory Stimulation

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.

Intervention Type: BEHAVIORAL

Multisensory Stimulation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Abant Izzet Baysal University

OTHER

Sponsor Role: lead

Responsible Party

Alp Ozel

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Alp Ozel, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

Abant Izzet Baysal University

Locations

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

Bolu, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Alp Ozel, PT, PhD

Role: CONTACT

alpozel@ibu.edu.tr

+903742534520 ext. 6155

Umut A Ugras, MD

Role: CONTACT

umutataugras@gmail.com

+905066434435

Facility Contacts

Umut A Ugras, MD

Role: primary

umutataugras@gmail.com

+905066434435

Other Identifiers

AIBU-FTR-AO-04

Identifier Type: -

Identifier Source: org_study_id