AnxietyNCT06704841
Effect of Music and Mindfulness Meditation
A study testing Music in combination with mindfulness in people with Anxiety, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety
- What is being tested?
- Music in combination with mindfulness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to 20 Feb 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be undergraduate college students majoring in a music degree.
- Participants must self-report feeling general anxiety at a level of 7/10 recently.
- Participants must be proficient English-readers and -speakers and be full-time enrolled students.
- Students of any gender and race/ethnic group may be included.
- Participants must be novice meditators, having fewer than 10 total meditation experiences.
- Students of any year will be accepted if they are considered undergraduate students by the university.
Who cannot join
- Self-reporting feeling general anxiety below a 7/10 recently.
- Having more than 10 total meditation experiences.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students.
- Conditions
- Anxiety
- Being tested
- Music in combination with mindfulness
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Music in combination with mindfulnessBehavioural
Participants will attend two in-person sessions per week over two consecutive weeks. Each session will be up to one hour in duration. During each session, participants will engage in a 20-minute guided meditation while listening to instrumental music.
| Study group | Role | What they receive |
|---|---|---|
| Music in combination with mindfulness group | Experimental | Participants in this group will receive music in combination with mindfulness group for up to two weeks. Receives: Behavioral: Music in combination with mindfulness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in State-Anxiety Inventory-5 questionnaire
The State-Anxiety Inventory-5 each consists of 5 items. The scale items are scored on a 4-point Likert scale of 1 to 4 (1= Not at all, 2= Somewhat, 3= Moderately so, 4= Very much so). Higher scores indicate greater anxiety.
Measured: Baseline, up to 1 hour post intervention
Secondary outcomes (1)
Change in Mindfulness Interoception measured by Likert scale
The scale items are scored on a 4-point Likert scale of 1 to 4 (1= Not at all, 2= Somewhat, 3= Moderately so, 4= Very much so). A higher score suggests higher mindful interoception skills.
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start12 Nov 2024
- Primary completion20 Feb 2025
- Study completion20 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 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, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704841
- Sponsor's protocol ID
- 20241057
- Status last verified
- Apr 2025
- First submitted
- 21 Nov 2024
- Last updated
- 27 Apr 2025
- 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 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Music and Mindfulness Meditation
- ClinicalTrials.gov ID
- NCT06704841
- Acronym / sponsor ID
- 20241057
- Conditions
- Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- 20 Feb 2025 (actual)
- Study completion
- 20 Feb 2025 (actual)
- First posted
- 26 Nov 2024 (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 the study is to explore the effect of music and mindfulness meditation on anxiety and mindful interoception in undergraduate music students.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Music in combination with mindfulness group | Experimental | Behavioral: Music in combination with mindfulnessParticipants in this group will receive music in combination with mindfulness group for up to two weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participants must be undergraduate college students majoring in a music degree.
- Participants must self-report feeling general anxiety at a level of 7/10 recently.
- Participants must be proficient English-readers and -speakers and be full-time enrolled students.
- Students of any gender and race/ethnic group may be included.
- Participants must be novice meditators, having fewer than 10 total meditation experiences.
Key exclusion criteria (2 listed)
- Self-reporting feeling general anxiety below a 7/10 recently.
- Having more than 10 total meditation experiences.
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 in combination with mindfulnessParticipants will attend two in-person sessions per week over two consecutive weeks. Each session will be up to one hour in duration. During each session, participants will engage in a 20-minute guided meditation while listening to instrumental music. | Behavioural | Music in combination with mindfulness group |
Primary outcome
Change in State-Anxiety Inventory-5 questionnaire
Time frame: Baseline, up to 1 hour post intervention
The State-Anxiety Inventory-5 each consists of 5 items. The scale items are scored on a 4-point Likert scale of 1 to 4 (1= Not at all, 2= Somewhat, 3= Moderately so, 4= Very much so). Higher scores indicate greater anxiety.
1 secondary outcome
Change in Mindfulness Interoception measured by Likert scale
Time frame: Baseline, 2 weeks
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 27 Apr 2025.
- 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, PhD 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 in combination with mindfulness in people with Anxiety, 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 6 inclusion and 2 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 27 Apr 2025. 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 State-Anxiety Inventory-5 questionnaire (time frame: Baseline, up to 1 hour post intervention). 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 27 Apr 2025.