StressNCT06166732
The Effect of Music-Based Mindfulness to Cope with Acculturative-Related Stress
A study testing Music-based Mindfulness in people with Stress, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international 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
- What is being tested?
- Music-based Mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Feb 2024to 29 Jul 2024
- 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
- 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
Who cannot join
- Individuals not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami, Volpe 206
Miami, Florida, 33146
About this study
Official title: The Effect of Music-Based Mindfulness on Acculturative Stress and Attention in East Asian International Students
The purpose of this study is to explore the effect of music-based mindfulness on stress reduction among East Asian international students.
- Conditions
- Stress
- Being tested
- Music-based Mindfulness, Control Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music-based MindfulnessBehavioural
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 GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Music-based Mindfulness Group | Experimental | Participants will receive a music-based mindfulness for 20 minutes. Receives: Behavioral: Music-based Mindfulness |
| Control Group | Other | Participants will receive a information session for 20 minutes. Receives: Behavioral: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 5 minutes before intervention and 5 minutes post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2023
- Study start17 Feb 2024
- Primary completion29 Jul 2024
- Study completion29 Jul 2024
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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 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, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06166732
- Sponsor's protocol ID
- 20231114
- Status last verified
- May 2024
- First submitted
- 4 Dec 2023
- Last updated
- 19 Sep 2024
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Music-Based Mindfulness on Acculturative Stress and Attention in East Asian International Students
- ClinicalTrials.gov ID
- NCT06166732
- Acronym / sponsor ID
- 20231114
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 17 Feb 2024 (actual)
- Primary completion
- 29 Jul 2024 (actual)
- Study completion
- 29 Jul 2024 (actual)
- First posted
- 12 Dec 2023 (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 music-based mindfulness on stress reduction among East Asian international students.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Music-based Mindfulness Group | Experimental | Behavioral: Music-based MindfulnessParticipants will receive a music-based mindfulness for 20 minutes. |
| Control Group | Other | Behavioral: Control GroupParticipants will receive a information session for 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals not meeting inclusion criteria
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 |
|---|---|---|
| Music-based MindfulnessThe participants will receive a single 20-minute music-based mindfulness session in person. The participants will listen to instrumental music during the session. | Behavioural | Music-based Mindfulness Group |
| Control GroupThe 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. | Behavioural | Control Group |
Primary outcome
Change in Spielberger State-Anxiety Inventory
Time frame: 5 minutes before intervention and 5 minutes post intervention
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
Change in researcher-designed attention scale
Time frame: 5 minutes before intervention and 5 minutes post intervention
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.
Change in Trail Making Test, Part A and B
Time frame: 5 minutes before intervention and 5 minutes post intervention
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.
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 19 Sep 2024.
- 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, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Music-based Mindfulness in people with Stress, run by University of Miami at 1 site 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 5 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Spielberger State-Anxiety Inventory (time frame: 5 minutes before intervention and 5 minutes post intervention). 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 19 Sep 2024.