Effectiveness of Familiar Voices and Nature Sounds Among Critically Ill Comatose Patients
NCT Number: NCT06470802
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Coma|Critical Illness|Unconsciousness
Interventions: BEHAVIORAL: Familiar voice|BEHAVIORAL: Nature sounds|BEHAVIORAL: Control
Sponsor: Vo Thi Hong Nhan
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 90
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-04-04
Completion Date: 2026-04
Locations: Intensive Care Unit, University Medical Center Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam|Neurosurgical Intensive Care Unit, University Medical Center Ho Chi Minh City, Ho Chi Minh City, 700000, Vietnam

Summary:
The goal of this clinical trial is to compare the effectiveness of auditory stimulation using familiar voices (FV) versus nature sounds (NS) on awakening critically ill comatose persons in the intensive care unit (ICU), reduce pain and stabilize their physiological parameters. The research question is: "What is the most effective auditory stimulus for improving consciousness, reducing pain, and stabilizing physiological parameters in critically ill comatose persons in the ICU?"

The research hypotheses are that, compared to those receiving nature sounds stimulation (active comparator group) and those receiving silence (control group), persons in unconsciousness who receive auditory stimulation from family members (experimental group) will show:

* Significant improvements in consciousness and pain intensity after the intervention
* Better stability of physiological parameters after the intervention

Primary Outcome Measures: Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Glasgow Coma Scale (GCS) after Intervention, The Glasgow Coma Scale (GCS) measure is used to assess the level of consciousness by measuring three categories of behavior: eye opening, vocalization, and motor movement. The score ranges from 3 to 15, with higher scores indicating a better LOC and lower scores indicating a poorer LOC. A score of 8 or lower on the GCS is often indicative of coma, Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention|Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Bispectral Index (BIS) after Intervention, The Bispectral Index (BIS) is measured using a non-invasive device that includes a forehead sensor, connection cable, and monitor screen. The results are displayed as a dimensionless number on a continuous scale from 0 to 100. A BIS value of 100 represents a state of full awareness and arousal, while a BIS of 0 indicates a very deep coma. BIS scores of 90-100 indicate the patient's alertness and response to verbal stimuli, while scores between 90-80 indicate reduced consciousness, 80-70 indicate a state of light sedation (response to loud commands), 70-60 indicate deep sedation (response to shaking), 60-40 indicate general anesthesia, scores below 40 indicate deep anesthesia, and scores below 20 indicate burst suppression, Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention
Secondary Outcome Measures: Change in Pain Intensity: Mean Change from Baseline in Pain Scores as Assessed by Critical Care Pain Observation Tool (CPOT) after Intervention, The CPOT is composed of four behavioral domains, including facial expression, body movements, muscle tension, and compliance with the ventilator (for mechanically ventilated patients) or vocalization (for extubated patients). Each domain is scored on a scale of 0-2, resulting in a total score of 0-8. A cut-off point of \> 2 was selected to indicate the presence of pain, Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention|Change in Systolic Blood Pressure (SBP): Mean Change from Baseline in Systolic Blood Pressure as Assessed by the value of Systolic Blood Pressure after Intervention, The SBP is monitored through the use of electronic monitors that are consistently connected to the persons, Four time points: 1 minutes before intervention, 5 minutes after starting intervention, immediately after stopping intervention and 5 minutes after stopping intervention for each intervention|Change in Diastolic Blood Pressure (DBP): Mean Change from Baseline in Diastolic Blood Pressure as Assessed by the value of Diastolic Blood Pressure after Intervention, The DBP is monitored through the use of electronic monitors that are consistently connected to the persons, Four time points: 1 minutes before intervention, 5 minutes after starting intervention, immediately after stopping intervention and 5 minutes after stopping intervention for each intervention|Change in Mean Arterial Pressure (MAP): Mean Change from Baseline in Mean Arterial Pressure as Assessed by the value of Mean Arterial Pressure after Intervention, The MAP is derived from Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP), weighted 1/3 SBP and 2/3 DBP, Four time points: 1 minutes before intervention, 5 minutes after starting intervention, immediately after stopping intervention and 5 minutes after stopping intervention, for each intervention|Change in Pulse Rate (PR): Mean Change from Baseline in Pulse Rate as Assessed by the value of Pulse Rate after Intervention, The PR is monitored through the use of electronic monitors that are consistently connected to the persons, Four time points: 1 minutes before intervention, 5 minutes after starting intervention, immediately after stopping intervention and 5 minutes after stopping intervention, for each intervention|Change in Oxygen Saturation: Mean Change from Baseline in Saturation of Peripheral Oxygen as Assessed by the value of Saturation of Peripheral Oxygen after Intervention, The oxygen saturation is monitored through the use of electronic monitors that are consistently connected to the persons, Four time points: 1 minutes before intervention, 5 minutes after starting intervention, immediately after stopping intervention and 5 minutes after stopping intervention, for each intervention|Number of participants regaining consciousness, The difference between the number of persons who receive intervention and the number of persons who achieve a Glasgow Coma Scores of 13 or 15 by day 7, Day 7