ComaNCT06470802
Effectiveness of Familiar Voices and Nature Sounds Among Critically Ill Comatose Patients
A study testing Familiar voice and Nature sounds in people with Coma and Critical Illness, run by Vo Thi Hong Nhan at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coma, Critical Illness, Unconsciousness
- What is being tested?
- Familiar voice and Nature sounds
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 2 sitesVietnam
- Study dates
- 4 Apr 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Intensive Care Unit, University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
Neurosurgical Intensive Care Unit, University Medical Center Ho Chi Minh City
Ho Chi Minh City, 700000
About this study
Official title: Effectiveness of Familiar Voices and Nature Sounds on Level of Consciousness, Pain Intensity and Physiological Parameters Among Critically Ill Comatose Patients
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
Read the detailed description
The recovery of consciousness in critically ill comatose persons is influenced by both internal factors, such as the severity of the critical illness, and external factors, such as sensory stimulation. Regular exposure to sensory stimuli can promote neuronal dendritic growth, improve synaptic connections, and enhance peripheral stimulation of the brain, which controls cognitive function. This supports the recovery of critically ill comatose person's consciousness. Sensory stimulation has also been found to be effective in reducing pain and anxiety for critically ill comatose persons.
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
- Coma, Critical Illness, Unconsciousness
- Being tested
- Familiar voice, Nature sounds, Control
- Keywords
- Comatose, Clinical Trial, Critical illness
- Medical subject headings
- Coma, Critical Illness, Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Familiar voiceBehavioural
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 soundsBehavioural
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
ControlBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Nature sounds |
| Control | Sham comparator | Patients receive a recording of silence only Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2024
- Study start4 Apr 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vo Thi Hong Nhan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Vo Thi Hong Nhan, University Medical Center Ho Chi Minh City (UMC)
- Investigators
- Nhan Vo Thi Hong, PhD Student, Principal investigator, University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06470802
- Sponsor's protocol ID
- 20/GCN-HDDD
- Status last verified
- Jan 2026
- First submitted
- 17 Jun 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol could be share to others under the study's publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Familiar Voices and Nature Sounds on Level of Consciousness, Pain Intensity and Physiological Parameters Among Critically Ill Comatose Patients
- ClinicalTrials.gov ID
- NCT06470802
- Acronym / sponsor ID
- 20/GCN-HDDD
- Conditions
- Coma, Critical Illness, Unconsciousness
- Keywords
- Comatose, Clinical Trial, Critical illness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Vo Thi Hong NhanUniversity, hospital or other
- Study start
- 4 Apr 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 24 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The recovery of consciousness in critically ill comatose persons is influenced by both internal factors, such as the severity of the critical illness, and external factors, such as sensory stimulation. Regular exposure to sensory stimuli can promote neuronal dendritic growth, improve synaptic connections, and enhance peripheral stimulation of the brain, which controls cognitive function. This supports the recovery of critically ill comatose person's consciousness. Sensory stimulation has also been found to be effective in reducing pain and anxiety for critically ill comatose persons.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Familiar voice (FV) | Experimental | Behavioral: Familiar voiceThe 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 |
| Nature sounds (NS) | Active comparator | Behavioral: Nature soundsThe 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 |
| Control | Sham comparator | Behavioral: ControlPatients receive a recording of silence only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Familiar voiceThe 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 | Behavioural | Familiar voice (FV) |
| Nature soundsThe 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 | Behavioural | Nature sounds (NS) |
| ControlThe 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 | Behavioural | Control |
Primary outcome
Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Glasgow Coma Scale (GCS) after Intervention
Time frame: Two time points: 5 minutes before intervention and immediately after stopping intervention for each 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
Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Bispectral Index (BIS) after Intervention
Time frame: Two time points: 5 minutes before intervention and immediately after stopping intervention for each 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
7 secondary outcomes
Change in Pain Intensity: Mean Change from Baseline in Pain Scores as Assessed by Critical Care Pain Observation Tool (CPOT) after Intervention
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: No. The study protocol could be share to others under the study's publication
Related trials for Coma
Not yet recruiting
Miniature In-line Respirator
Brain Death, Respiration, Artificial
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Minimal Sedation Versus Standard Continuous Sedation After Out-of-Hospital Cardiac Arrest
Out-of-Hospital Cardiac Arrest, Hypoxic-Ischemic Brain Injury
RecruitingObservational study
AI-based Algorithm Development for Improved Diagnostics in the Intensive Care and Acute Stroke Setting Using Electroencephalography
Hemorrhagic Stroke, Intracerebral, Subarachnoid Haemorrhage (SAH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nhan Vo Thi Hong, PhD Student principal investigator
University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Familiar voice and Nature sounds in people with Coma and Critical Illness, run by Vo Thi Hong Nhan at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Glasgow Coma Scale (GCS) after Intervention (time frame: Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.