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NCT Number: NCT05732584

Effect of Auditory Stimulation by Family Voices in Preventing Delirium: A Randomized Controlled Trial

Delirium is an acute cerebral dysfunction syndrome characterized by acute fluctuating changes in consciousness, cognitive dysfunction, and disorientation. It's especially common in critically ill patients of emergency intensive care units and seriously threatens the survival and prognosis of patients and causes heavy economic burdens to the family, society, and medical service system. Impaired verbal communication, unfamiliar medical personnel, physical restraint, spatial-temporal disorientation, mechanical ventilation and sedation medication use can lead to a lack of adequate sensory stimulation and a high risk of delirium. Acoustic stimulation as a non-invasive non-pharmacological intervention can provide some sensory stimulation as a surrogate for critically ill patients. This research designs the content scripts from the needs of ICU patients and families for sound stimulation. The goal of this randomized controlled study is to test the effect of auditory stimulation by family voices in preventing delirium among sedative patients in emergency Intensive care units.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

About this study

Patients are separated from their families and society under the closed management of the intensive care unit, the use of sedative drugs, mechanical ventilation, impaired verbal communication, physical restraint, environmental noise, and prolonged light exposure, which lead to a lack of adequate sensory stimulation, causing sensory deprivation in patients to some extent. In turn, sensory deprivation may cause multisensory perceptual confusion and hallucinations, affecting patients' orientation and thinking and triggering delirium, so providing appropriate sensory stimulation to critically ill patients may help to improve patients' orientation and attention, correct patients' thinking confusion and prevent delirium, and in clinical practice, sensory stimulation is considered as an important part of multicomponent delirium prevention programs.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • transferred to the EICU from emergency admission
  • no other history of emergency, surgery, or ICU admission history within 30 days
  • no delirium in the first screening of Emergency Intensive Care Unit(EICU) admission
  • with an expected length of stay in EICU longer than 24h and use of sedation medication

Exclusion criteria

  • Presence of hearing impairment, severe dementia, psychiatric disorder, or other severe brain dysfunction that hinders delirium assessment
  • persistent coma or deep sedation (RASS score of -4 to -5)
  • patients without a family member who can cooperate with the recording
  • external ear disease or surgery that hinders earphone wearing

Treatment and study plan

structured family voice stimulation

Other

The structured family voice stimulation is played to the patients for the first five days after admission to eicu until transfer out or death. The content of the recording is developed according to the structured script.

unstructured family voice stimulation

Other

The unstructured family voice stimulation is played to the patients for the first five days after admission to eicu until transfer out or death.

Primary outcomes

  1. incidence of delirium

    Time frame: up to 5 days

    use the Confusion Assessment Method for the ICU (CAM-ICU)

Secondary outcomes

  1. delirium severity

    Time frame: up to 5 days

    use Confusion Assessment Method for the Intensive Care Unit 7-item (CAM-ICU-7), ranging from 0-7 , higher scores means higher delirium severity.

  2. delirium duration

    Time frame: up to 5 days

    use the Confusion Assessment Method for the ICU (CAM-ICU)

  3. delirium-free days

    Time frame: up to 5 days

    use the Confusion Assessment Method for the ICU (CAM-ICU)

  4. delirium subtype

    Time frame: up to 5 days

    use the Confusion Assessment Method for the ICU (CAM-ICU) and Richmond Agitation Sedation Scale(RASS)

  5. time to first delirium

    Time frame: up to 5 days

    use the Confusion Assessment Method for the ICU (CAM-ICU)

  6. family anxiety levels

    Time frame: up to 5 days

    families were assessed using the Self-Rating Anxiety Scale (SAS) at the beginning and at the end of the intervention. (The score ranges from 25 to 100 and higher scores means more anxious situation)

  7. family depression levels

    Time frame: up to 5 days

    families were assessed using the Self-Rating Depression Scale (SDS) at the beginning and at the end of the intervention. (The score ranges from 25 to 100 and higher scores means more depressed situation)

  8. Duration of mechanical ventilation

    Time frame: up to 5 days

    Duration of use of mechanical ventilation

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Effect of Auditory Stimulation by Family Voices in Preventing Delirium Among Sedative Patients in Emergency Intensive Care Units :A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Feb 17, 2023
Registry last updated
Feb 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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