StressNCT05590910
The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing Students
A study testing Music in people with Stress, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Music
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2022to 10 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Enrolled at UT Health San Antonio School of Nursing clinical course
- First semester undergraduate nursing student
Who cannot join
- Under 18 years
- Second, third or fourth semester undergraduate nursing student
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Stress
- Being tested
- Music
- Keywords
- Music, anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicOther
Also called Classical music
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.
| Study group | Role | What they receive |
|---|---|---|
| Music Intervention Group | Experimental | 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. Receives: Other: Music |
| Non-Music Control Group | No intervention | Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart Rate Measurement
Heart rate will be measured using a smartwatch Time 1 (pre-intervention) Time 2 (post-intervention) Time 3 (post-skill)
Measured: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
Blood Pressure Measurement
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
Measured: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
State Trait Anxiety Inventory (STAI)
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.
Measured: Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
Academic Performance
Measuring the Skills Competency Recording Performance (Pass/Fail basis)
Measured: Baseline to study end (approximately 45 minutes from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start9 Mar 2022
- Primary completion10 Aug 2022
- Study completion10 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled approach will explore the effects music has on stress and anxiety levels and academic performance among undergraduate nursing students.
- Masking
- None (open label)
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorgie A Contreras, MSN, Principal investigator, The University of Texas Health Science Center at San Antonio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590910
- Sponsor's protocol ID
- HSC20210672H
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2022
- Last updated
- 3 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be shared with other faculty and published in a peer reviewed journal.
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Music Intervention on Stress, Anxiety, and Academic Performance Among New Undergraduate Nursing Students
- ClinicalTrials.gov ID
- NCT05590910
- Acronym / sponsor ID
- HSC20210672H
- Conditions
- Stress
- Keywords
- Music, anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 9 Mar 2022 (actual)
- Primary completion
- 10 Aug 2022 (actual)
- Study completion
- 10 Oct 2022 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Posted 3 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled approach will explore the effects music has on stress and anxiety levels and academic performance among undergraduate nursing students.
| Arm | Type | Receives |
|---|---|---|
| Music Intervention Group | Experimental | Other: MusicThe 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. |
| Non-Music Control Group | No intervention | –Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years and older
- Enrolled at UT Health San Antonio School of Nursing clinical course
- First semester undergraduate nursing student
Key exclusion criteria (2 listed)
- Under 18 years
- Second, third or fourth semester undergraduate nursing student
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MusicAlso: Classical musicFifteen 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 | Music Intervention Group |
Primary outcome
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)
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
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)
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.
Academic Performance
Time frame: Baseline to study end (approximately 45 minutes from baseline)
Measuring the Skills Competency Recording Performance (Pass/Fail basis)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. De-identified data will be shared with other faculty and published in a peer reviewed journal.
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorgie A Contreras, MSN principal investigator
The University of Texas Health Science Center at San Antonio
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music in people with Stress, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.