Effect of Music and Mindfulness Meditation

NCT06704841 | Completed

• 1 other identifier: 20241057
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anxiety

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Mindfulness Interoception measured by Likert scale

  Baseline, 2 weeks

Study Arms (1)

Music in combination with mindfulness group

EXPERIMENTAL

Participants in this group will receive music in combination with mindfulness group for up to two weeks.

Behavioral: Music in combination with mindfulness

Interventions

Music in combination with mindfulness BEHAVIORAL

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.

Music in combination with mindfulness group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Teresa Lesiuk, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 21, 2024
• First Posted: November 26, 2024
• Study Start: November 12, 2024
• Primary Completion: February 20, 2025
• Study Completion: February 20, 2025
• Last Updated: April 27, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)