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

NCT06470802 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2026-01-06

No results posted yet for this study

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

Conditions

  • Coma
  • Critical Illness
  • Unconsciousness

Interventions

BEHAVIORAL

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

BEHAVIORAL

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

BEHAVIORAL

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

Sponsors & Collaborators

  • Vo Thi Hong Nhan

    lead OTHER

Principal Investigators

  • Nhan Vo Thi Hong, PhD Student · University of Medicine and Pharmacy at Ho Chi Minh City, University Medical Center Ho Chi Minh City

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-04
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Vietnam

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06470802 on ClinicalTrials.gov