NCT05590910

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 10, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

October 18, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 21, 2022

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

May 3, 2024

Completed
Last Updated

May 3, 2024

Status Verified

November 1, 2023

Enrollment Period

5 months

First QC Date

October 18, 2022

Results QC Date

October 21, 2022

Last Update Submit

November 29, 2023

Conditions

Keywords

Music, anxiety

Outcome Measures

Primary Outcomes (4)

  • Heart Rate Measurement

    Heart rate will be measured using a smartwatch Time 1 (pre-intervention) Time 2 (post-intervention) Time 3 (post-skill)

    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

    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.

    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)

    Baseline to study end (approximately 45 minutes from baseline)

Study Arms (2)

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.

Other: Music

Non-Music Control Group

NO INTERVENTION

Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.

Interventions

MusicOTHER

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.

Also known as: Classical music
Music Intervention Group

Eligibility Criteria

Age18 Years+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsNon-Binary
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years and older
  • Enrolled at UT Health San Antonio School of Nursing clinical course
  • First semester undergraduate nursing student

You may not qualify if:

  • Under 18 years
  • Second, third or fourth semester undergraduate nursing student

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Jorgie Ann Contreras
Organization
UT Health San Antonio-Faculty; Texas Woman's University-Student

Study Officials

  • Jorgie A Contreras, MSN

    University of Texas Health Science Center San Antonio

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: A randomized controlled approach will explore the effects music has on stress and anxiety levels and academic performance among undergraduate nursing students.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 18, 2022

First Posted

October 21, 2022

Study Start

March 9, 2022

Primary Completion

August 10, 2022

Study Completion

October 10, 2022

Last Updated

May 3, 2024

Results First Posted

May 3, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will share

De-identified data will be shared with other faculty and published in a peer reviewed journal.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Data will be shared at close of study and after data analysis is completed.

Locations