Completed

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

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Study Aim

This study aims to evaluate the effectiveness of familiar voices and nature sounds in improving the level of consciousness in critically ill comatose patients, as measured by the Bispectral Index (BIS) and Glasgow Coma Scale (GCS).

What is being tested

Familiar voice

+ Nature sounds

+ Control

Behavioral
Who is being recruted

Coma+8

+ Consciousness Disorders

+ Nervous System Diseases

Over 18 Years
See all eligibility criteria
How is the trial designed

Supportive Care Study

Placebo-Controlled
Interventional
Study Start: April 2024
See protocol details

Summary

Principal SponsorVo Thi Hong Nhan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 4, 2024

Actual date on which the first participant was enrolled.

The study is exploring how different sounds may help people who are in a coma due to a severe illness. It focuses on using familiar voices like those of caregivers or loved ones, as well as nature sounds, to see if they can help awaken these patients or reduce their pain and anxiety. Hearing is believed to be the last sense that fades in a coma, which makes auditory stimulation a practical option. This study is important because it aims to find the most effective type of sound to aid in the recovery of consciousness for these patients, which is currently unclear due to limited research. Participants in this study will be exposed to different types of sounds, including familiar voices and nature sounds, to see how these affect their level of consciousness, pain levels, and other physiological signs. These sounds are delivered in a non-invasive manner, meaning they do not require any physical intervention. The study seeks to measure improvements in consciousness and reductions in pain and anxiety, comparing these results to routine care practices. By understanding which type of auditory stimulation works best, the study aims to provide clearer guidance for healthcare providers in supporting comatose patients.

Official TitleEffectiveness of Familiar Voices and Nature Sounds on Level of Consciousness, Pain Intensity and Physiological Parameters Among Critically Ill Comatose Patients
NCT06470802
Principal SponsorVo Thi Hong Nhan
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

90 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Supportive Care Study

These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

ComaConsciousness DisordersNervous System DiseasesNeurologic ManifestationsPathologic ProcessesSigns and SymptomsPathological Conditions, Signs and SymptomsUnconsciousnessCritical IllnessNeurobehavioral ManifestationsDisease Attributes

Criteria

Inclusion Criteria: * 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) Exclusion Criteria: * 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 * Prior or current inclusion in other sensory stimulation study * Current inclusion in other study

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

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

Group III

Sham
Patients receive a recording of silence only

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Intensive Care Unit, University Medical Center Ho Chi Minh City

Ho Chi Minh City, VietnamOpen Intensive Care Unit, University Medical Center Ho Chi Minh City in Google Maps
Suspended

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

Ho Chi Minh City, Vietnam
Completed2 Study Centers