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

Vo Thi Hong Nhan

Status: Enrolling

Conditions: Unconsciousness; Coma; Critical Illness

Treatments: Behavioral: Familiar voice; Behavioral: Control; Behavioral: Nature sounds

Study type: Interventional

Funder types: Other

Identifiers

NCT06470802

20/GCN-HDDD

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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90 participants in 3 patient groups

Familiar voice (FV)

Experimental group

Description:

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

Treatment:

Behavioral: Familiar voice

Nature sounds (NS)

Active Comparator group

Description:

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

Treatment:

Behavioral: Nature sounds

Control

Sham Comparator group

Description:

Patients receive a recording of silence only

Treatment:

Behavioral: Control