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Completed

NCT Number: NCT04159584

Pilot Study: The Effects of Medical Music on Anxiety in Patients With ILD

This is uncontrolled, interventional feasibility study for determining the effects medical music on anxiety levels in subjects with ILD. Enrolled subjects will be asked to complete questionnaires and undergo physiologic measurements prior to listening to medical music. The music intervention will be for approximately 30 minutes. Post intervention questionnaires and physiologic measurements will be done.

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Key information

Conditions

Interstitial Lung Disease Lung Diseases Lung Diseases, Interstitial Respiratory Tract Diseases

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Weill Cornell Medicine

New York, 10065, United States

About this study

The Medical Music intervention includes playlists that contains songs specifically designed, recorded, and optimized through the provisionally-patented methods, to treat their co-morbid anxiety. The duration of the medical music playlist is 30 minutes.

Enrolled subjects will be asked to complete questionnaires to assess anxiety, a questionnaire related to their music preferences, and undergo physiological measurements (vital signs, galvanic skin response, and heart rate variability) before and after the intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Men and women age 50 to 80 years old
  • Diagnosis of definite or probable interstitial lung disease (ILD)
  • Willingness to participate and sign consent

Exclusion criteria

  • Patients who are deaf
  • Inability to provide informed consent
  • Pregnant women

Treatment and study plan

Medical Music

Other

Enrolled subjects will undergo 30 minutes of medical music listening

Primary outcomes

  1. Feasibility of using a medical music intervention as a treatment for anxiety in subjects with ILD, as measured by descriptive evaluation.

    Time frame: Baseline to 30 minutes

Secondary outcomes

  1. Change in State Anxiety Inventory scores before and after intervention

    Time frame: Baseline to 30 min

    The State-Trait Anxiety Inventory Questionnaire is a psychological inventory based on a 4-point Likert scale and consists of 40 questions on a self-report basis. It measures two types of anxiety - state anxiety, or anxiety about an event, and trait anxiety, or anxiety level as a personal characteristic.

  2. Change in Visual Analogue Scale scores for Anxiety and Distress (VAS-A) before and after intervention

    Time frame: Baseline to 30 min

    The VAS-A is a psychometric response scale to measure respondents level of anxiety and stress by indicating a position along a continuous line between two end-points ("not at all" to "extremely").

  3. Change in Borg Dyspnea Scale scores before and after intervention

    Time frame: Baseline to 30 min

    The Borg Dyspnea Scale measures perceived dyspnea on a scale from 0 to 10.

  4. Change in heart rate variability before and after intervention

    Time frame: Baseline to 30 min

    Heart rate variability will be measured before and after intervention

  5. Change in galvanic skin response before and after intervention

    Time frame: Baseline to 30 min

    Galvanic skin response will be measured before and after intervention

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Collaborators

  • Neuralpositive

Registry information

Official study title

Pilot Study: The Effects of Medical Music on Anxiety in Patients With Interstitial Lung Disease

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Nov 12, 2019
Registry last updated
Jan 31, 2020

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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