CompletedNot Applicable

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

Vietnam90 participantsStarted 2024-04-04

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Glasgow Coma Scale (GCS) after Intervention

Timeframe: 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

Timeframe: Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention

Trial details

NCT IDNCT06470802

SponsorVo Thi Hong Nhan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Coma trials

Plain-language summary

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Level of Consciousness: Mean Change from Baseline in Level of Consciousness as Assessed by Glasgow Coma Scale (GCS) after Intervention

Timeframe: 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

Timeframe: Two time points: 5 minutes before intervention and immediately after stopping intervention for each intervention