Effect of Music and Mindfulness Meditation

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 Overview

• Status: Completed
• Conditions: Anxiety
• Intervention / Treatment: Behavioral: Music in combination with mindfulness

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Self-reporting feeling general anxiety below a 7/10 recently.
• Having more than 10 total meditation experiences.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Music in combination with mindfulness group; Participants in this group will receive music in combination with mindfulness group for up to two weeks.	Behavioral: Music in combination with mindfulness; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, up to 1 hour post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 2 weeks

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Teresa Lesiuk, PhD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2024
• Primary Completion (Actual): February 20, 2025
• Study Completion (Actual): February 20, 2025

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Actual): November 26, 2024

Study Record Updates

• Last Update Posted (Actual): April 27, 2025
• Last Update Submitted That Met QC Criteria: April 25, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 20241057

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No