NCT06166732

Brief Summary

The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international students.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 12, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

February 17, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 29, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 29, 2024

Completed
Last Updated

September 19, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

December 4, 2023

Last Update Submit

September 16, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • Change in Spielberger State-Anxiety Inventory

    The Spielberger State-Trait Anxiety Inventory survey which has six-item short-form of the state(STAI: Y-6 score. To calculate the total STAI score (range 20 - 80): * reverse scoring of the positive items (calm, relaxed, content) so 1=4, 2=3, 3=2 and 4=1; * sum all six scores; * multiply total score by 20/6; * refer to Spielberger's manuals to interpret scores (a 'normal' score is approx. 34 - 36) Participant will complete the survey 5 minutes prior to the intervention and then 5 minutes after the intervention

    5 minutes before intervention and 5 minutes post intervention

  • Change in researcher-designed attention scale

    There are two items. The first item "I am very focused in the present right now" will utilize a 5-point scale ranging from 1= "Not at All" to 5= "Extremely." Conversely, the second item "I have a lot of distracting thoughts right now" will be measured using a reversed score. In this context, higher scores signify greater levels of attention. A composite score of these two items will be reported.

    5 minutes before intervention and 5 minutes post intervention

  • Change in Trail Making Test, Part A and B

    The Trail Making Test (TMT) is a timed test and the goal is to complete the test as accurately and as quickly as possible. Raw scores are reported in seconds to complete the test. For Part B, an average score is 75 seconds and a deficient score is greater than 273 seconds. The present study reports T-scores, which can range from a minimum of 0 and a maximum of 100. The higher the T- score achieved by a participant, the better the performance, indicating a higher level of functioning.

    5 minutes before intervention and 5 minutes post intervention

Study Arms (2)

Music-based Mindfulness Group

EXPERIMENTAL

Participants will receive a music-based mindfulness for 20 minutes.

Behavioral: Music-based Mindfulness

Control Group

OTHER

Participants will receive a information session for 20 minutes.

Behavioral: Control Group

Interventions

The participants will receive a single 20-minute music-based mindfulness session in person. The participants will listen to instrumental music during the session.

Music-based Mindfulness Group
Control GroupBEHAVIORAL

The participants will receive a single 20-minute information session in person. The information session will introduce the definition, history, basic concepts, and benefits of mindfulness practice.

Control Group

Eligibility Criteria

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

You may qualify if:

  • Being 18 years of age or older
  • Pursuing an undergraduate/graduate degree with an F-1 visa
  • Originating from regions including China, Hong Kong, Taiwan, North Korea, South Korea, and Japan
  • Living in the United States for no more than 3 years
  • Having less than one year of mindfulness practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami, Volpe 206

Miami, Florida, 33146, United States

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Teresa Lesiuk, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

December 4, 2023

First Posted

December 12, 2023

Study Start

February 17, 2024

Primary Completion

July 29, 2024

Study Completion

July 29, 2024

Last Updated

September 19, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations