- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05590910
The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing Students
November 29, 2023 updated by: The University of Texas Health Science Center at San Antonio
The Effects of a Music Intervention on Stress, Anxiety, and Academic Performance Among New Undergraduate Nursing Students
This study is examining the effect of listening to music on personal variables such as stress, anxiety, and academic performance.
Previous research has shown that listening to music can help in reducing the effects of anxiety and stress.
Study Overview
Detailed Description
Students will be divided and randomized into two recording groups: 1.) Music Intervention Group, 2.) Non-Music Control Group.
The music intervention group will receive a 15-minute music intervention and variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
The non-music control group will not receive the intervention; however, the same variables will be measured.
Study Type
Interventional
Enrollment (Actual)
89
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
-
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Texas
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San Antonio, Texas, United States, 78229
- The University of Texas Health Science Center at San Antonio
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-
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
14 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18 years and older
- Enrolled at UT Health San Antonio School of Nursing clinical course
- First semester undergraduate nursing student
Exclusion Criteria:
- Under 18 years
- Second, third or fourth semester undergraduate nursing student
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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Music Intervention Group
The music intervention group will receive a 15-minute music intervention and variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
Fifteen minutes of classical music will be played overhead in the classroom.
The students will be instructed not to use other electronic devices such as ear buds or phones during this time.
Other Names:
|
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No Intervention: Non-Music Control Group
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate Measurement
Time Frame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
|
Heart rate will be measured using a smartwatch Time 1 (pre-intervention) Time 2 (post-intervention) Time 3 (post-skill)
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Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
|
|
Blood Pressure Measurement
Time Frame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
|
Change in Blood pressure will be measured using a smartwatch.
Only MAP reported: the average arterial pressure throughout one cardiac cycle, systole, and diastole Time 1 Time 2 Time 3
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Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
|
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State Trait Anxiety Inventory (STAI)
Time Frame: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
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Change in score on the STAI survey, a 20 item survey with each item rated on a 4 point scale from "almost never" to "almost always.
Possible range of scores are from 20-80 with a higher score indicating greater anxiety.
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Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
|
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Academic Performance
Time Frame: Baseline to study end (approximately 45 minutes from baseline)
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Measuring the Skills Competency Recording Performance (Pass/Fail basis)
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Baseline to study end (approximately 45 minutes from baseline)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jorgie A Contreras, MSN, University of Texas Health Science Center San Antonio
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)
March 9, 2022
Primary Completion (Actual)
August 10, 2022
Study Completion (Actual)
October 10, 2022
Study Registration Dates
First Submitted
October 18, 2022
First Submitted That Met QC Criteria
October 18, 2022
First Posted (Actual)
October 21, 2022
Study Record Updates
Last Update Posted (Actual)
May 3, 2024
Last Update Submitted That Met QC Criteria
November 29, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSC20210672H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be shared with other faculty and published in a peer reviewed journal.
IPD Sharing Time Frame
Data will be shared at close of study and after data analysis is completed.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
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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