NCT07116941

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

Effects of Multisensory and Cognitive Interventions Applied in the Intensive Care Unit on Physiological, Psychological and Functional Outcomes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 125 (estimated)
• Sponsor: Abant Izzet Baysal University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.
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.

Timeline

• Start date: 2025-08-01
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2025-08-12
• Last updated: 2026-02-12

Locations

1 site across 1 country: Turkey (Türkiye)