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

NCT04159584 | Completed

• 1 other identifier: 1901019911
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

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

  Baseline to 30 minutes

Secondary Outcomes (5)

• Change in State Anxiety Inventory scores before and after intervention

  Baseline to 30 min

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

  Baseline to 30 min

• Change in Borg Dyspnea Scale scores before and after intervention

  Baseline to 30 min

• Change in heart rate variability before and after intervention

  Baseline to 30 min

• Change in galvanic skin response before and after intervention

  Baseline to 30 min

Study Arms (1)

Enrolled Subject

EXPERIMENTAL

All subjects will undergo the medical music intervention.

Other: Medical Music

Interventions

Medical Music OTHER

Enrolled subjects will undergo 30 minutes of medical music listening

Enrolled Subject

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Neuralpositive: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Study Officials

• Robert Kaner, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an uncontrolled, interventional pilot study to determine feasibility

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: November 12, 2019
• Study Start: April 15, 2019
• Primary Completion: September 11, 2019
• Study Completion: September 11, 2019
• Last Updated: January 31, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 6 months after the publication
• Access Criteria: De-identified data will be available to the public upon request in a timely fashion.

Locations

US (1)