Using familiar voices and nature sounds to help awaken comatose patients
Effectiveness of Familiar Voices and Nature Sounds on Level of Consciousness, Pain Intensity and Physiological Parameters Among Critically Ill Comatose Patients
This study is testing if playing familiar voices or nature sounds can help wake up comatose patients in the ICU better than silence.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Medical Center Ho Chi Minh City (UMC) Academic / other |
| Locations | 2 sites (Ho Chi Minh City and 1 other locations) |
| Trial ID | NCT06470802 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of auditory stimulation through familiar voices compared to nature sounds in awakening critically ill comatose patients in the ICU. The study will assess improvements in consciousness, pain reduction, and stabilization of physiological parameters among participants. Patients will be divided into three groups: those receiving familiar voice stimulation, those receiving nature sounds, and a control group receiving silence. The trial seeks to provide evidence on the best auditory stimulus for enhancing recovery in comatose individuals.
Who should consider this trial
Good fit: Ideal candidates include critically ill patients in the ICU with a Glasgow Coma Scale score of 5-12 who have been stable for at least 24 hours.
Not a fit: Patients who have been in a coma for longer than three months or have severe underlying conditions such as cardiac arrest or neuromuscular disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for critically ill comatose patients by enhancing their consciousness and reducing pain.
How similar studies have performed: Previous studies have shown some success with auditory stimulation in awakening comatose patients, but this trial aims to provide more robust evidence with a larger sample size.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Ho Chi Minh City and 1 other locations
- Intensive Care Unit, University Medical Center Ho Chi Minh City — Ho Chi Minh City, Vietnam (Recruiting)
- Neurosurgical Intensive Care Unit, University Medical Center Ho Chi Minh City — Ho Chi Minh City, Vietnam (Recruiting)
Study contacts
- Principal investigator: Nhan Vo Thi Hong, PhD Student — University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City
- Study coordinator: Nhan Vo Thi Hong, PhD Student
- Email: nhan.vth@umc.edu.vn
- Phone: +84 986907833
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.