The Effects of a Music Intervention on Stress, Anxiety, and Academic Performance Among New Undergraduate Nursing Students
Phase: NA
Conditions: Stress
Sponsor: The University of Texas Health Science Center at San Antonio

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COVER PAGE FOR PROTOCOL AND STATISTICAL ANALYSIS PLAN 
 
 
 
 
 
Official Study Title: The Effects of a Music Intervention on Stress, Anxiety and 
Academic Performance on Nursing Students 
 
NCT number: NCT05590910 
 
IRB Approval Date: 05.23.2022 
 
Unique Protocol ID: HSC20210672H 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Protocol Template Form 
 
Item 1 UTHSCSA 
Tracking Number 
HSC20210672H:  
 
The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing 
Students 
 
 
Item 2 Abstract / Project Summary 
Provide a succinct and accurate description of the proposed research. 
State the purpose/aims. Describe concisely the research design and 
methods for achieving the stated goals. This section should be 
understandable to all members of the IRB, scientific and non-scientific.  
DO NOT EXCEED THE SPACE PROVIDED. 
Purpose/Objectives: The purpose of this study is to assess whether a music intervention, compared with no music 
intervention, influences stress and anxiety levels and academic performance of undergraduate nursing students. 
 
Research Design/Plan: A randomized controlled approach will explore the effects music has on stress and anxiety levels 
and academic performance among undergraduate nursing students. 
 
Methods: 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.  
 
Clinical Relevance: Music has been shown to beneficially affect stress-related physiological, as well as cognitive, and 
emotional processes. The proposed study has the potential to highlight the acceptance of music used as a strategy for 
impacting stress and anxiety experienced by nursing students during their undergraduate studies. Evidence of any effect 
music has on stress and anxiety levels among undergraduate studies can determine existence by the measurement of 
vital signs, STAI responses, and skills performance. This type of study can be beneficial to further research and can be 
implemented by nurse educators, healthcare institutions, and wellness clinics. 
 
 
 
 
Item 3 
Background 
 
Describe past experimental 
and/or clinical findings 
leading to the formulation 
of your study.   
For research involving 
unapproved drugs, 
describe animal and 
human studies.   
For research that involves 
approved drugs or devices, 
describe the FDA approved 
Nursing students experience higher levels of stress than students in any other health science 
academic programs (Kinchen & Loerzel, 2019). Since most nursing students are not able to 
avoid these stressors, students must be able to cope with them. If students are not able to 
manage their stress, it can affect their performance, health, attitude, and role satisfaction as 
a nurse (Rafati et al., 2017). The levels of stress may vary during students’ educational 
training, depending on their ability to adopt various strategies or coping with stress, and 
other factors. Even though numerous studies have been published regarding stress and 
anxiety among nursing students, few studies are found addressing the benefits of music 
utilized as an intervention to decrease emotional stress.  

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uses of this drug/device in 
relation to your protocol. 
 
Item 4 
Purpose and rationale 
Insert purpose, objectives 
and research 
questions/hypotheses 
here. 
 If you cut and paste from 
another document, make 
sure the excerpted 
material answers the 
question 
Music is an immensely powerful emotional tool that can be used as a coping mechanism for 
stress, but there is truly little existing research about its use by students. This study aims to 
explore the effects of music intervention on the stress and anxiety levels among nursing 
students in their first semester of undergraduate studies. Increased awareness of their own 
strategies used, as well as the willingness to use holistic methods such as music, can offer a 
non-pharmacological and inexpensive intervention to many institutions.  
 
Research Questions: 
1. Is there a relationship between listening to music and stress, anxiety, and academic 
performance among new undergraduate nursing students? 
2. Does listening to music help in decreasing anxiety among new undergraduate nursing 
students who are anticipating a skills assessment? 
3. Does listening to music help in decreasing stress among new undergraduate nursing 
students who are anticipating a skills assessment? 
4. Does listening to music help to improve academic performance among new undergraduate 
nursing students? 
 
 
 
Item 5 
Study Population(s) Being 
Recruited 
 
In your recruitment plan, how 
many different populations of 
prospective subjects do you plan to 
target? Provide number: 1 
 
Identify the criteria for inclusion: 
Identify the criteria for exclusion: 
e.g., a population can be individuals 
with type 2 diabetes controlled with 
diet and/or a population of healthy 
controls.  Or a population can be 
individuals attending an education 
program, etc. 
 
List each different population on a 
separate row and provide a short 
descriptive label:   
(e.g., normal-healthy, diabetics, 
parents, children, etc.) 
 
To add rows use copy & paste 
Nursing Students 
18 years and older 
Enrolled at UTHSCSA- School of 
Nursing 
Enrolled in a Foundations of Nursing 
Clinical  course 
First semester undergraduate nursing 
student 
Younger than 18 years old 
2nd , 3rd ,4th semester undergraduate nursing 
student 

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Insert response here 
Insert response here 
Insert response here 
 
 
Item 6 
Research Plan / Description of the Research Methods a.  Provide a comprehensive narrative describing the research methods.   
Provide the plan for data analysis (include as applicable the sample size calculation). 
 
Step-by-Step Methods:  
 
A randomized controlled approach will explore the effects music has on stress and anxiety levels and 
academic performance among undergraduate nursing students. The study will be conducted with nursing 
students in the first semester of the undergraduate BSN program at UT Health Science Center at San 
Antonio. The study will consist of Phase 1 (pilot) and Phase 2 (larger dissertation study). Phase 1 will be the 
pilot study conducted in Spring 2022. The total population of the cohort typically consists of ≈108 students. 
Approximately half-way through the semester, the students are required to sign-up for a skills competency 
recording. The students select the best date and time for their schedule. Students sign-up electronically into 
a group consisting of up to 10 students. Typically, there are 30 min time slots  available for sign-up For Phase 
1, the pilot study will use a cluster randomization procedure to randomly assign two of the sign-up groups. 
The two groups will be 1) the music intervention group (n=up to 10 participants), and 2.) the non-music 
control group (n= up to 10 participants). An online randomizer will be used to create the groups. Students 
assigned to these groups will be allowed to remove themselves. The academic performance of these 
students will be recorded for the study. 
 
Phase 2 of the study will be informed from the findings of Phase 1, the pilot study. It is anticipated there will 
be no intended changes in the methodology or randomization procedures from Phase 1 to Phase 2. The only 
difference would be in Phase 2 the total population in the Summer 2022 cohort (n≈108) will be randomized 
into approximately 6 slots per half hour . Any changes to be made for Phase 2 will be immediately 
communicated to the IRB for approval prior to implementation. 
 
The following procedures will be used for Phase 1 and Phase 2: 
The study will be conducted at the UT Health Science Center - San Antonio’s Center for Simulation 
Innovation (CSI).  Two classrooms will be reserved in the CSI area at the School of Nursing. Students will be 
divided into the recording time slots consisting of no more than 10 students at a time. The students receiving 
the music intervention will be assigned an iPad (only used to sync smartwatch), a hard copy of State Trait 
Anxiety Inventory (STAI) survey forms Y-1 and Y-2, a demographic data form, pencil, and smart watch. 
Students will be advised to sit quietly, with desks spread out, in the reserved room. The participants will be 
asked to complete the STAI survey forms prior to music listening. Students will be advised to wear the watch, 
and watches will be previously logged in and synced by researcher to measure heart rate and blood 
pressure. Vital sign sheet will be completed by researcher using the data from the iPad. 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. The STAI survey Y-1 will be completed again 
post-intervention, and heart rate and blood pressure re-assessed. Students will then proceed to perform the 
skills competency assessment. Vitals and STAI survey Y-1 will then be reassessed post-skills competency and 
academic performance (pass/fail) will be measured. 
 
The students who will not be receiving the music intervention (control group) will be seated in a second 
reserved classroom and will be repeating the same process as the music intervention group except without 
music, instead they will be sitting quietly for 15 minutes waiting to record their skills competency. The 
students will also be instructed not to use other electronic devices such as ear buds or phones during this 
time. For any students who have been randomly assigned to either group, and refuse to be in the study, they 

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will be allowed to leave. Only the academic performance will be measured on these students that refuse to 
be assigned to a group. 
 
Data Analysis Plan: 
A priori power analysis was conducted using G*Power 3.1.9 to determine the minimum sample size required 
to find statistical significance using a 3 (group) x 4 (time) repeated measures analysis of variance (i.e., a 
mixed-model ANOVA). With a desired level of power set at .80, an alpha (α) level at .05, and a moderate 
effect size of .25 (f), it was determined that a minimum of 30 total participants would be required to ensure 
adequate power (Cohen, 1988). 
 
Mean heart rate, mean blood pressure, mean scores on STAI, and academic performance score (Pass/Fail) 
will be calculated for all groups. Demographic data will be analyzed in terms of frequencies and comparisons 
between groups. For RQ1: Pearson’s correlation will examine the relationship between the music 
intervention on stress, anxiety, and academic performance. For RQ2: To measure anxiety, STAI mean scores 
will be analyzed. For RQ3: To measure stress levels, the mean heart rate and mean blood pressure will be 
analyzed. For RQ4: To assess academic performance, Pass/fail scores will be looked at. MANOVA will be 
considered for data analysis since there is one independent variable (music intervention) and multiple 
dependent variables. If any variables are not correlated, running a repeated-measures ANOVA to detect any 
overall differences between any related means would be considered. A paired samples t-tests could also be 
used for pre-and post-comparisons of vital signs. Using a Chi-Square test can also be beneficial in 
determining any differences in demographics and anxiety and/or stress.  Alpha will be set at 0.05 for the 
study. 
 
 
Item 7 Risks Section: 
Complete the following table to describe the risks of all research procedures listed in Step 2, Institutional Form (items 28-34).  Do not list risks of Routine care 
procedures here.  
 
 N/A, Risks are described in the informed consent document – do not complete this table. 
Research procedures 
 
example: 
• 
History and physical 
• 
Questionnaire 
• 
Laboratory tests 
 
Add or delete rows as needed 
Risks 
 
List the reasonably expected risks 
under the following categories as appropriate: 
Vitals Signs obtained via 
SmartWatch 
 
Heart Rate 
Blood Pressure 
Serious and likely; 
o None 
Serious and less likely; 
o None 
Demographic data form, paper and 
pencil 
Serious and likely; 
None 
STAI Survey: paper and pencil 
survey 
Serious and likely; 
o None 
Academic Performance 
Serious and likely; 
o Pass/Fail