NCT06289634

Brief Summary

Multiple studies have highlighted music's ability to evoke diverse emotional states. Past research reveals that factors like musical elements, and the environment impact how people respond emotionally to music. For instance, faster tempos tend to heighten arousal, while minor key compositions evoke more arousal compared to major key compositions. In efforts to induce specific emotions post-stress, the research found that both pleasant and sad music aided stress recovery. Similarly, other researchers noted that positively rated music was more effective in reducing stress than negatively rated music, especially low arousal compositions over high arousal ones. Several studies focused on applying music to reduce stress and anxiety. In addition to man-made musical tones, the positive impact of natural surroundings on emotional state has been widely explored. A psycho-evolutionary viewpoint was offered, suggesting that humans have evolved in natural settings, making us inherently attuned to them physically and psychologically. A non-threatening natural environment, rich in aesthetically pleasing elements like visible escape routes, greenery, and water, tends to reduce stress and generate interest. In this study, the researchers are exploring how different sounds-man-made instrumental music versus natural sounds-affect stress, anxiety, and mood among the students of Medgar Evers College. Using an experimental approach, the researchers will assess pretest stress levels (via the perceived stress scale (PSS), anxiety (generalized anxiety disorder (GAD-7), and mood (four-dimensional mood scale (4DMS) among a sample of students. After randomly dividing them into two groups, each group will listen to one of the designated sounds (man-made music or nature sounds) for 30 minutes daily over 15 days. The researchers will then have them retake the stress, anxiety, and mood scales for post-test comparison. Statistical analysis (mixed ANOVA) will help to compare scores within and between groups. Ultimately, this study aims to determine the influence of tonal input on stress and anxiety levels among students, crucial given the significant stress they often experience.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Mar 2024

Shorter than P25 for not_applicable healthy

Status
not yet recruiting

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

February 22, 2024

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
28 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 4, 2024

Status Verified

February 1, 2024

Enrollment Period

1 month

First QC Date

February 22, 2024

Last Update Submit

February 28, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Stress

    Measured by Perceived Stress Scale (PSS). Individual scores on the PSS can range from 0 to 40 with higher scores indicating higher perceived stress.

    15 days

  • Anxiety

    Measured by General Anxiety Disorder Scale (GAD-7). The outcome of the questionnaire is reported as a score between 0 and 21 with 0 indicating no anxiety and 21 indicating the highest level of anxiety.

    15 days

  • Mood

    Measured by Four Dimension Mood Scale (4DMS), It is designed to measure positive energy (4 items-minimum score is 4 and maximum score is 20), tiredness (5 items, minimum score is 5 and maximum score is 25), negative activation (6 items-minimum score is 6 and maximum score is 30), and relaxation (5 items-minimum score is 5 and maximum score is 25). Higher scores indicate greater appearance of the corresponding mood.

    15 days

Study Arms (2)

Man-made sounds

EXPERIMENTAL

Participants who listen to man-made sounds (music)

Behavioral: Man-made sounds

Natural sounds

EXPERIMENTAL

Participants who listen to natural sounds (e.g., ocean, birds, rain)

Behavioral: Natural sounds

Interventions

Man-made soundsBEHAVIORAL

Participants will be asked to listen to the assigned sounds (relaxing music) for 30 minutes a day for 15 days.

Man-made sounds
Natural soundsBEHAVIORAL

Participants will be asked to listen to the assigned sounds (birds, ocean, wind) for 30 minutes a day for 15 days.

Natural sounds

Eligibility Criteria

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

You may qualify if:

  • Being a student at Medgar Evers College, CUNY
  • Being 18 years old or older

You may not qualify if:

  • Having hearing problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sokhadze EM. Effects of music on the recovery of autonomic and electrocortical activity after stress induced by aversive visual stimuli. Appl Psychophysiol Biofeedback. 2007 Mar;32(1):31-50. doi: 10.1007/s10484-007-9033-y.

    PMID: 17333313BACKGROUND
  • van der Zwaag MD, Dijksterhuis C, de Waard D, Mulder BL, Westerink JH, Brookhuis KA. The influence of music on mood and performance while driving. Ergonomics. 2012;55(1):12-22. doi: 10.1080/00140139.2011.638403.

    PMID: 22176481BACKGROUND
  • Wang J, Qiu X, Kulkarni A, Hauer-Jensen M. Calcitonin gene-related peptide and substance P regulate the intestinal radiation response. Clin Cancer Res. 2006 Jul 1;12(13):4112-8. doi: 10.1158/1078-0432.CCR-06-0592.

    PMID: 16818712BACKGROUND
  • Ulrich RS. Effects of interior design on wellness: theory and recent scientific research. J Health Care Inter Des. 1991;3:97-109.

    PMID: 10123973BACKGROUND

Study Officials

  • Sumeyra Tosun

    Medgar Evers College

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sumeyra Tosun

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 22, 2024

First Posted

March 4, 2024

Study Start

March 1, 2024

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

March 4, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share