Effectiveness of Familiar Voices and Nature Sounds Among Critically Ill Comatose Patients

NCT06470802 | Completed DMC

• 1 other identifier: 20/GCN-HDDD
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Coma; Critical Illness; Unconsciousness

Keywords

Comatose; Clinical Trial; Critical illness

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Change in Pain Intensity: Mean Change from Baseline in Pain Scores as Assessed by Critical Care Pain Observation Tool (CPOT) after Intervention

  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

  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

  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

  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

  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

Study Arms (3)

Familiar voice (FV)

EXPERIMENTAL

The recording features pleasant, optimistic, and normal voices in style of daily verbal communication between the patient and their family members (storytellers). The recording begins with the storytellers calling patient by their own name, repeated at least three times throughout the recording. The storytellers introduce themselves by name and their relationship to the patient. They will provide information about the patient's surroundings, the time and the current situation. The recording includes words of love and affection, encouragement, stories, meaning and familiar memories shared by both the patient and the storytellers. These stories should hold a special meaning and evoke fond memories to the patient. The storytellers also discuss about the patient's recovery prospects and plans after their discharge from the hospital. These storytellers must have a close relationship with the patient and have interacted with them for at least one year prior to their current condition

Behavioral: Familiar voice

Nature sounds (NS)

ACTIVE COMPARATOR

The audio is a compilation of pleasant sounds that capture the essence of a pristine natural environment with the soft rustling of wind through leaves, the gentle rustle of wind, the melodic chirping of birds and the bubbling of a flowing stream

Behavioral: Nature sounds

Control

SHAM COMPARATOR

Patients receive a recording of silence only

Behavioral: Control

Interventions

Familiar voice BEHAVIORAL

The recording is provided to the patient through a smartphone with a music player application, using noise-free Bluetooth earphones for 15 minutes per session, twice daily (morning and afternoon shift), for 7 consecutive days. Each session is separated by at least a 2-hour interval

Familiar voice (FV)

Nature sounds BEHAVIORAL

The recording is provided to the patient through a smartphone with a music player application, using noise-free Bluetooth earphones for 15 minutes per session, twice daily (morning and afternoon shift), for 7 consecutive days. Each session is separated by at least a 2-hour interval

Nature sounds (NS)

Control BEHAVIORAL

The recording is provided to the patient through a smartphone with a music player application, using noise-free Bluetooth earphones for 15 minutes per session, twice daily (morning and afternoon shift), for 7 consecutive days. Each session is separated by at least a 2-hour interval

Control

Eligibility Criteria

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

You may qualify if:

• Patients who have been admitted to the intensive care unit for a minimum of 24 hours
• Patients with a Glasgow Coma Scale scores of 5-12
• Patients have a stable hemodynamic status for at least 24 hours before being enrolled in the study
• Patients who have undergone surgery at least 24 hours prior to being enrolled in the study (if applicable)

You may not qualify if:

• Coma lasting longer than three months
• Patients experiencing cardiac arrest for more than four minutes, cardiac arrhythmias, neuromuscular disorders, and seizures during coma
• Patients with a history of chronic pain, hearing impairment, previous traumatic brain injury or stroke, or damage to the ears at the time of the study
• Patients with skull fractures, surgery, or wounds in both temporal lobes or ears that may affect headphone connection
• Those with addiction to alcohol or drugs
• Pregnant women

Sponsors & Collaborators

• Vo Thi Hong Nhan: lead

Study Sites (2)

Intensive Care Unit, University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

Neurosurgical Intensive Care Unit, University Medical Center Ho Chi Minh City

Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Coma; Critical Illness; Unconsciousness

Condition Hierarchy (Ancestors)

Consciousness Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Nhan Vo Thi Hong, PhD Student

  University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2024
• First Posted: June 24, 2024
• Study Start: April 4, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: January 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)