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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06166732
Other study ID # 20231114
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 17, 2024
Est. completion date October 30, 2024

Study information

Verified date May 2024
Source University of Miami
Contact Teresa Lesiuk, Ph.D.
Phone 305-284-3650
Email tlesiuk@miami.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date October 30, 2024
Est. primary completion date October 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: • Individuals not meeting inclusion criteria

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Music-based Mindfulness
The participants will receive a single 20-minute music-based mindfulness session in person. The participants will listen to instrumental music during the session.
Control Group
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.

Locations

Country Name City State
United States University of Miami, Volpe 206 Miami Florida

Sponsors (1)

Lead Sponsor Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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