- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02955108
The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Diseases
July 30, 2021 updated by: NYU Langone Health
The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Disease
The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance.
Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate.
The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise.
The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This randomized clinical trial will use a cross-over design.
The research will include two within-subject factors, music versus no music and time.
Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- New York University School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- English speaking
- aged 40 years or older, with physician-diagnosed COPD
a flow volume loop with a FEV1/FVC of < 0.70 in the past 12 months
- medically cleared to participate in NYULMC's pulmonary rehabilitation program.
Exclusion Criteria:
- Inability to exercise due to musculoskeletalor neurological dysfunction
- Inability to walk independently (unaided)
- deafness or severe hearing impairment requiring hearing aids
- mMRC score = 0 ("I only get breathlessness with strenuous exercise").
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: music first then no music
|
Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT.
The instructions to participants for selecting the music will be standardized.
TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition.
Participants will not be specifically instructed to synchronize their walking movements with the music tempo.
The music is based on a cognitive therapy (distraction) strategy conceptual framework.
Music will be played during the 6MWT (in-task) only.
Participants will wear headphones with no music playing
|
Experimental: no music first then music
|
Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT.
The instructions to participants for selecting the music will be standardized.
TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition.
Participants will not be specifically instructed to synchronize their walking movements with the music tempo.
The music is based on a cognitive therapy (distraction) strategy conceptual framework.
Music will be played during the 6MWT (in-task) only.
Participants will wear headphones with no music playing
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dyspnea Intensity (DI)
Time Frame: 60 Minutes
|
Borg Breathlessness Scale.
The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)".
Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64
Validity of the Borg scale for measuring dyspnea intensity has been shown.65
|
60 Minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Anna Maria Norweg, New York University Medical School
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 27, 2017
Primary Completion (Actual)
November 14, 2018
Study Completion (Actual)
November 14, 2018
Study Registration Dates
First Submitted
November 2, 2016
First Submitted That Met QC Criteria
November 2, 2016
First Posted (Estimate)
November 4, 2016
Study Record Updates
Last Update Posted (Actual)
August 3, 2021
Last Update Submitted That Met QC Criteria
July 30, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 16-01676
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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