StressNCT06647420
The Effect of Music Listening on Nursing Students
A study testing Sedative Music and Stimulative Music in people with Stress and Physiological Stress, run by University of Miami at 3 sites in United States.
Trial summary
The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Physiological Stress
- What is being tested?
- Sedative Music and Stimulative Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Oct 2024to 5 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- a senior, junior, or second-semester sophomore in the traditional undergraduate Bachelor of Science in Nursing (BSN) program
- a student in the accelerated BSN program
Who cannot join
- •self-reported hearing impairments.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Miami School of Nursing and Health Studies
Coral Gables, Florida, 33146
University of Miami
Coral Gables, Florida, 33146
Weeks Music Library and Technology Center
Coral Gables, Florida, 33146
About this study
Official title: The Effect of Sedative and Stimulative Music Listening on State-Anxiety, Heart Rate, and Galvanic Skin Response in Nursing Students
The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.
- Conditions
- Stress, Physiological Stress
- Being tested
- Sedative Music, Stimulative Music
- Keywords
- Heart rate, Skin conductance, Music
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedative MusicBehavioural
The participants will come twice in person and listen to 9 minutes of sedative music.
Stimulative MusicBehavioural
The participants will come twice in person and listen to 9 minutes of stimulative music.
| Study group | Role | What they receive |
|---|---|---|
| Sedative music followed by stimulative music group | Experimental | The participants in this group will receive sedative music followed by stimulative music for up to 25 minutes each. Session two will occur two days after session one. Receives: Behavioral: Sedative Music; Behavioral: Stimulative Music |
| Stimulative music followed by sedative music group | Experimental | The participants in this group will receive stimulative music followed by sedative music for up to 25 minutes each. Session two will occur two days after session one. Receives: Behavioral: Sedative Music; Behavioral: Stimulative Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart Rate
Heart rate will be measured using the Polar Verity Sense Optical Heart Rate Sensor in beats per minute (bpm)
Measured: baseline, up to 12 minutes
Change in Skin Conductance
Skin conductance will be measured using the NeuLog Galvanic Skin Response (GSR) in micro Siemens (µS).
Measured: baseline, up to 12 minutes
Change in Anxiety Level
The Six Item State-Trait Anxiety Inventory includes six statements that are rated on a 4-point Likert scale (1=Not at all, 2=Somewhat, 3=Moderately so, 4=Very much). The scale will measure current feelings of anxiety.
Measured: baseline, up to 12 minutes
Secondary outcomes (3)
The Degree of Stress Experienced by A Nursing Student measured by the Perceived Stress Scale for Nursing Students (PSS) Likert Scale
The PSS consists of 29 items that are rated on a 5-point Likert scale (1=Never, 2=Seldom, 3=Sometimes, 4=Often, 5=Always). The PSS measures the degree of stress experienced by a nursing student based on stressful factors relevant to the demanding nursing curriculum.
Measured: up to 5 minutes
Liking Song Scale (4-point Likert Scale)
Each music playlist will consist of three songs. The participant will rate how much the participant liked each of the three songs on a 4-point Likert scale (1=Not at all, 2=Somewhat, 3=Moderately so, 4=Very much).
Measured: up to 5 minutes
Familiarity Song Scale (Rating scale)
Each music playlist will consist of three songs. The participant will indicate how familiar the participant is with each of the three songs on a rating scale (0=No, 1= I'm not sure, 2=Yes). The results of each song will be added to represent a quasi-continuous variable for how familiar the participant was with the music playlist as a whole.
Measured: up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2024
- Study start21 Oct 2024
- Primary completion5 Feb 2025
- Study completion5 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Teresa Lesiuk, University of Miami
- Investigators
- Teresa Lesiuk, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647420
- Sponsor's protocol ID
- 20241018
- Status last verified
- Oct 2024
- First submitted
- 16 Oct 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sedative and Stimulative Music Listening on State-Anxiety, Heart Rate, and Galvanic Skin Response in Nursing Students
- ClinicalTrials.gov ID
- NCT06647420
- Acronym / sponsor ID
- 20241018
- Conditions
- Stress, Physiological Stress
- Keywords
- Heart rate, Skin conductance, Music
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 21 Oct 2024 (actual)
- Primary completion
- 5 Feb 2025 (actual)
- Study completion
- 5 Feb 2025 (actual)
- First posted
- 17 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedative music followed by stimulative music group | Experimental | Behavioral: Sedative Music, Behavioral: Stimulative MusicThe participants in this group will receive sedative music followed by stimulative music for up to 25 minutes each. Session two will occur two days after session one. |
| Stimulative music followed by sedative music group | Experimental | Behavioral: Sedative Music, Behavioral: Stimulative MusicThe participants in this group will receive stimulative music followed by sedative music for up to 25 minutes each. Session two will occur two days after session one. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a senior, junior, or second-semester sophomore in the traditional undergraduate Bachelor of Science in Nursing (BSN) program
- a student in the accelerated BSN program
Key exclusion criteria (1 listed)
- •self-reported hearing impairments.
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 |
|---|---|---|
| Sedative MusicThe participants will come twice in person and listen to 9 minutes of sedative music. | Behavioural | Sedative music followed by stimulative music group, Stimulative music followed by sedative music group |
| Stimulative MusicThe participants will come twice in person and listen to 9 minutes of stimulative music. | Behavioural | Sedative music followed by stimulative music group, Stimulative music followed by sedative music group |
Primary outcome
Change in Heart Rate
Time frame: baseline, up to 12 minutes
Heart rate will be measured using the Polar Verity Sense Optical Heart Rate Sensor in beats per minute (bpm)
Change in Skin Conductance
Time frame: baseline, up to 12 minutes
Skin conductance will be measured using the NeuLog Galvanic Skin Response (GSR) in micro Siemens (µS).
Change in Anxiety Level
Time frame: baseline, up to 12 minutes
The Six Item State-Trait Anxiety Inventory includes six statements that are rated on a 4-point Likert scale (1=Not at all, 2=Somewhat, 3=Moderately so, 4=Very much). The scale will measure current feelings of anxiety.
3 secondary outcomes
The Degree of Stress Experienced by A Nursing Student measured by the Perceived Stress Scale for Nursing Students (PSS) Likert Scale
Time frame: up to 5 minutes
Liking Song Scale (4-point Likert Scale)
Time frame: up to 5 minutes
Familiarity Song Scale (Rating scale)
Time frame: up to 5 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- Individual participant dataSharing planned: No
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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.
Teresa Lesiuk, PhD principal investigator
University of Miami
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedative Music and Stimulative Music in people with Stress and Physiological Stress, run by University of Miami at 3 sites 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 2 inclusion and 1 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 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Heart Rate (time frame: baseline, up to 12 minutes). The study lists 3 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 18 Apr 2025.