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NCT Number: NCT04977011

Effectiveness of Music Intervention on Anxiety and Physiological Responses in Critical Ill Patient

Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in Intensive Care Unit (ICU) is still unknown. The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU. This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety. Agitation Sedation Scale, sleep quality and physical parameters were selected to collect as secondary outcomes.There was no significant difference between the groups at baseline. The results of this study support that music can reduce anxiety and agitation levels in ICU's patient. Nurses can incorporate this intervention into the daily care in order to reduce the discomfort of patients.

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Key information

Conditions

Diabetic Ketoacidosis Aberrant Motor Behavior in Dementia Acid-Base Imbalance Acidosis Acute Kidney Injury Anxiety Disorders Behavior Behavioral Symptoms Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebral Hemorrhage Cerebrovascular Disorders Craniocerebral Trauma Diabetes Complications Diabetes Mellitus Digestive System Diseases Dyskinesias Dyssomnias Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Bleeding Gastrointestinal Diseases Gastrointestinal Hemorrhage Head Injury Heart Disease, Ischemic Heart Diseases Heart Failure Hemorrhage Infections Inflammation Intracerebral Hemorrhage Intracranial Hemorrhages Ketosis Kidney Diseases Liver Diseases Lung Diseases Male Urogenital Diseases Mental Disorders Metabolic Diseases Myocardial Ischemia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Psychomotor Agitation Psychomotor Disorders Renal Insufficiency Respiration Disorders Respiratory Failure Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Sepsis Septic Shock Shock Shock, Septic Signs and Symptoms Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Stroke Systemic Inflammatory Response Syndrome Trauma Trauma, Nervous System Urogenital Diseases Urologic Diseases Vascular Diseases Wounds and Injuries

Age range

20 year–102 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MinSheng General Hospital

Taoyuan, Taiwan

About this study

Background:Music intervention is a non-pharmacological and effective intervention that can alleviate anxiety and agitation in patients undergoing weaning. The effectiveness of music intervention in reducing anxiety of patients in ICU is still unknown.

Objectives: The purpose of this study was to examine the effectiveness of music intervention on anxiety, agitation, sleep quality and physiological parameters on patients in ICU.

Methods: This study was conducted from January to June 2019. A total of 196 hospitalized ICU patients were divided into two groups. Subjects in experimental group received 30 minutes music intervention for 3 days on bedside whereas subjects in control group received routine care only. The primary outcome was anxiety measured by Visual Analog Scale. Richmond Agitation Sedation Scale, Richards-Campbell Sleep Scale and their physical parameters were selected to collect the secondary outcomes.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 20 years or older and staying in an intensive care unit.
  • Patients within 24 hours of admission (Acute Physiology And Chronic Health Evaluation, APACHE II score) ≦25 points.
  • Can express their intentions by writing or shaking their heads.
  • Can communicate in Mandarin, Taiwanese, Hakka or English.
  • After explaining the purpose of the research, agree to participate and fill out the consent form.

Exclusion criteria

  • Dementia or mental illness are recorded

Treatment and study plan

Relaxing Music

Other

30 minutes relaxing music for continuity 3 days since admission

Primary outcomes

  1. Anxiety Visual Analog Scale.

    Time frame: 3day

    The Visual Analogue Scale for Anxiety (VASA) is a line 10 centimetres in length with "not at all anxious" and "very anxious" at the left and right extremes respectively.

Secondary outcomes

  1. Richmond Agitation Sedation Scale

    Time frame: 3 day

    The Richmond Agitation-Sedation Scale (RASS) was developed in a collaborative effort with practitioners representing critical care physicians, nurses, and pharmacists. RASS is a 10-point scale, with four levels of anxiety or agitation (+1 to +4 [combative]), one level to denote a calm and alert state (0), and 5 levels of sedation (-1 to -5) culminating in unarousable (-5).

  2. Richards-Campbell Sleep Scale

    Time frame: 3 day

    The RCSQ is used in order to assess sleep quality in eligible ICU patients. The RCSQ is a six-item self-report questionnaire that is used in order to assess perceived sleep depth, sleep latency (time to fall asleep), and number of awakenings, as well as sleep efficiency, quality and perceived nighttime noise. Each RCSQ item is scored on a visual analog scale ranging from 0 mm to 100 mm, with higher scores representing better sleep. The mean score of the six items is known as the total score and represents the overall perception of sleep.

Sponsors and collaborators

Lead sponsor

Min-Sheng General Hospital

Other

Registry information

Official study title

Effectiveness of Music Intervention on Anxiety in Critical Ill Patient: Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jul 26, 2021
Registry last updated
Jul 26, 2021

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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