Trial Outcomes & Findings for The Effects of a Music Intervention on Stress, Anxiety and Academic Performance on Nursing Students (NCT NCT05590910)
NCT ID: NCT05590910
Last Updated: 2024-05-03
Results Overview
Heart rate will be measured using a smartwatch Time 1 (pre-intervention) Time 2 (post-intervention) Time 3 (post-skill)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
Baseline (pre-intervention), Time 2 (post intervention, approximately 30 minutes from baseline) and study end (approximately 45 minutes from baseline)
Results posted on
2024-05-03
Participant Flow
Participant milestones
| Measure |
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.
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.
|
Non-Music Control Group
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
40
|
|
Overall Study
COMPLETED
|
49
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
Baseline characteristics by cohort
| Measure |
Music Intervention Group
n=49 Participants
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.
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.
|
Non-Music Control Group
n=40 Participants
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
27.55 years
STANDARD_DEVIATION 6.63 • n=99 Participants
|
24.75 years
STANDARD_DEVIATION 4.47 • n=107 Participants
|
26.29 years
STANDARD_DEVIATION 5.73 • n=206 Participants
|
|
Sex/Gender, Customized
Male
|
11 Participants
n=99 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
7 Participants
n=107 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
18 Participants
n=206 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
|
Sex/Gender, Customized
Female
|
37 Participants
n=99 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
33 Participants
n=107 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
70 Participants
n=206 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
|
Sex/Gender, Customized
Non-Binary
|
1 Participants
n=99 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
0 Participants
n=107 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
1 Participants
n=206 Participants • Participants Self-Identified as 70 females, 18 males, and 1 non-binary student
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
37 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
60 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
37 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
White
|
17 participants
n=99 Participants
|
6 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 participants
n=99 Participants
|
5 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 participants
n=99 Participants
|
1 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other/Mixed
|
4 participants
n=99 Participants
|
3 participants
n=107 Participants
|
7 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
49 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 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)
Outcome measures
| Measure |
Music Intervention Group
n=49 Participants
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.
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.
|
Non-Music Control Group
n=40 Participants
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
|---|---|---|
|
Heart Rate Measurement
Time 1
|
83.45 beats per minute
Standard Deviation 11.75
|
82.80 beats per minute
Standard Deviation 11.92
|
|
Heart Rate Measurement
Time 2
|
81.88 beats per minute
Standard Deviation 11.82
|
84.38 beats per minute
Standard Deviation 10.87
|
|
Heart Rate Measurement
Time 3
|
89.31 beats per minute
Standard Deviation 13.61
|
91.13 beats per minute
Standard Deviation 14.71
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Music Intervention Group
n=49 Participants
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.
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.
|
Non-Music Control Group
n=40 Participants
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
|---|---|---|
|
Blood Pressure Measurement
Time 1
|
91.88 mmHg
Standard Deviation 4.82
|
91.39 mmHg
Standard Deviation 5.85
|
|
Blood Pressure Measurement
Time 2
|
91.14 mmHg
Standard Deviation 4.69
|
90.89 mmHg
Standard Deviation 6.40
|
|
Blood Pressure Measurement
Time 3
|
93.28 mmHg
Standard Deviation 3.99
|
92.08 mmHg
Standard Deviation 4.21
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Music Intervention Group
n=49 Participants
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.
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.
|
Non-Music Control Group
n=40 Participants
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
|---|---|---|
|
State Trait Anxiety Inventory (STAI)
Time 1
|
43.84 STAI Scores
Standard Deviation 10.69
|
43.77 STAI Scores
Standard Deviation 10.04
|
|
State Trait Anxiety Inventory (STAI)
Time 2
|
36.92 STAI Scores
Standard Deviation 12.81
|
41.63 STAI Scores
Standard Deviation 12.96
|
|
State Trait Anxiety Inventory (STAI)
Time 3
|
37.51 STAI Scores
Standard Deviation 11.36
|
38.38 STAI Scores
Standard Deviation 11.62
|
PRIMARY outcome
Timeframe: Baseline to study end (approximately 45 minutes from baseline)Measuring the Skills Competency Recording Performance (Pass/Fail basis)
Outcome measures
| Measure |
Music Intervention Group
n=49 Participants
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.
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.
|
Non-Music Control Group
n=40 Participants
Variables such as heart rate, blood pressure, anxiety, and academic performance will be measured.
|
|---|---|---|
|
Academic Performance
Pass
|
36 participants
|
26 participants
|
|
Academic Performance
Fail
|
13 participants
|
14 participants
|
Adverse Events
Music Intervention Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-Music Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jorgie Ann Contreras
UT Health San Antonio-Faculty; Texas Woman's University-Student
Phone: 2107235319
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place