Effectiveness of Familiar Voices and Nature Sounds Among Critically Ill Comatose Patients
NCT ID: NCT06470802
Last Updated: 2026-01-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
90 participants
INTERVENTIONAL
2024-04-04
2025-12-31
Brief Summary
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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
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Detailed Description
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Among sensory stimuli, auditory stimulation is the most feasible intervention because it is non-invasive, easy to perform, less expensive, and most importantly, hearing is the last sense to be lost when a person is in a coma state. Auditory stimulation can be delivered in various forms, such as the voice of caregivers or loved ones, natural sounds, or music. These non-invasive interventions have shown potential in improving patients' health outcomes and are safe for nurses to proactively implement.
Some studies have provided evidence that intense and repeated auditory stimulation can help to awaken persons from coma earlier or reduce pain. However, these studies have been limited by small sample sizes, with only comparisons between single stimulation and routine care or other types of sensory stimulation, or with the reporting of only some parameters. As a results, there is a lack of strong evidence regarding the specific type of auditory stimulation that is most effective for critically ill comatose person's recovery. This makes it difficult for nurses to identify the best stimulus to use for these persons. Therefore, further well-designed research studies should be conducted to observe significant differences regarding the effectiveness of familiar voices and nature sounds among critically ill comatose persons. This approach will enable a comprehensive evaluation and comparison of the effectiveness of these two auditory stimulation.
The investigators hypothesize that auditory stimulation is more effective in recovering critically ill comatose persons than routine care. Additionally, the investigators will also test the hypothesis that the effectiveness of auditory stimulation generated by familiar voices is higher than that provided by nature sounds.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
TRIPLE
Study Groups
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Familiar voice (FV)
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
Familiar voice
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)
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
Nature sounds
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
Patients receive a recording of silence only
Control
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
Interventions
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Familiar voice
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
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
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Vo Thi Hong Nhan
OTHER
Responsible Party
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Vo Thi Hong Nhan
Principal Investigator
Principal Investigators
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Nhan Vo Thi Hong, PhD Student
Role: PRINCIPAL_INVESTIGATOR
University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City
Locations
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Intensive Care Unit, University Medical Center Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Neurosurgical Intensive Care Unit, University Medical Center Ho Chi Minh City
Ho Chi Minh City, , Vietnam
Countries
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Other Identifiers
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20/GCN-HDDD
Identifier Type: -
Identifier Source: org_study_id
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