NCT06647420

Brief Summary

The purpose of this study is to explore the effect of sedative and stimulative music listening on physiological responses among nursing students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

October 16, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 17, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

October 21, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 5, 2025

Completed
Last Updated

April 18, 2025

Status Verified

October 1, 2024

Enrollment Period

4 months

First QC Date

October 16, 2024

Last Update Submit

April 15, 2025

Conditions

Keywords

Heart rateSkin conductanceMusic

Outcome Measures

Primary Outcomes (3)

  • Change in Heart Rate

    Heart rate will be measured using the Polar Verity Sense Optical Heart Rate Sensor in beats per minute (bpm)

    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).

    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.

    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

    up to 5 minutes

  • Liking Song Scale (4-point Likert Scale)

    up to 5 minutes

  • Familiarity Song Scale (Rating scale)

    up to 5 minutes

Study Arms (2)

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.

Behavioral: Sedative MusicBehavioral: 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.

Behavioral: Sedative MusicBehavioral: Stimulative Music

Interventions

Sedative MusicBEHAVIORAL

The participants will come twice in person and listen to 9 minutes of sedative music.

Sedative music followed by stimulative music groupStimulative music followed by sedative music group

The participants will come twice in person and listen to 9 minutes of stimulative music.

Sedative music followed by stimulative music groupStimulative music followed by sedative music group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • self-reported hearing impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Miami School of Nursing and Health Studies

Coral Gables, Florida, 33146, United States

Location

University of Miami

Coral Gables, Florida, 33146, United States

Location

Weeks Music Library and Technology Center

Coral Gables, Florida, 33146, United States

Location

Study Officials

  • Teresa Lesiuk, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 17, 2024

Study Start

October 21, 2024

Primary Completion

February 5, 2025

Study Completion

February 5, 2025

Last Updated

April 18, 2025

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations