- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07359950
Film-Based Music Therapy With AI-Generated Verbal Guidance for Anxiety in Young Adults (EAST-MUSIC)
Effects of Film-Based Music Therapy With LLM-Generated Culturally Adapted Verbal Suggestions on Anxiety, Affect, and Heart Rate Among Chinese Young Adults: A Randomized Controlled Trial
This study aims to examine whether music-based relaxation combined with different types of verbal guidance can help reduce anxiety and improve emotional well-being in young adults.
University students often experience high levels of stress related to academic demands and daily life. Music listening is commonly used as a simple and safe method to promote relaxation. In addition to music itself, verbal guidance during music listening may influence how individuals imagine, interpret, and emotionally respond to the music experience.
In this study, participants are randomly assigned to one of three groups. One group listens to music accompanied by verbal guidance generated by a large language model and designed to reflect Eastern aesthetic imagery. A second group listens to music with standard relaxation guidance commonly used in music therapy. A third group listens to relaxing music without any verbal guidance. Each participant takes part in a single music listening session lasting approximately 25-30 minutes.
Levels of anxiety, positive and negative emotions, and heart rate are measured before and after the music session. By comparing the results across the three groups, this study seeks to better understand whether culturally adapted verbal guidance can enhance the effects of music-based relaxation for young adults.
Study Overview
Status
Conditions
Detailed Description
This study is a single-center, randomized controlled trial designed to investigate the effects of music-based interventions with different types of verbal guidance on anxiety and emotional regulation in young adults.
Eligible university students are recruited and randomly assigned in equal numbers to one of three parallel groups: (1) a music intervention with verbal guidance generated by a large language model and designed to evoke Eastern aesthetic imagery; (2) a standard music therapy condition that includes conventional relaxation-oriented verbal suggestions; and (3) a music-only relaxation condition without verbal guidance. Randomization is conducted using a simple random allocation procedure.
All participants complete baseline assessments prior to the intervention. Each participant then takes part in a single music listening session lasting approximately 25-30 minutes in a quiet classroom setting. During the session, participants are seated comfortably with eyes closed and instructed to listen attentively to the music. Verbal guidance, when present, is delivered by a researcher during the music session.
Primary and secondary outcomes are assessed immediately before and after the intervention. Anxiety is measured using a standardized self-report anxiety scale. Emotional states are assessed using validated measures of positive and negative affect. Heart rate is recorded as an objective physiological indicator of autonomic arousal using a smartphone-based photoplethysmography method.
This study aims to provide empirical evidence on whether culturally adapted verbal guidance, generated by artificial intelligence, can enhance the psychological and physiological effects of music-based relaxation in young adults.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sichuan
-
Aba, Sichuan, China
- Aba Teachers College
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age between 18 and 25 years at the time of enrollment.
- Currently enrolled as a university student.
- Able to understand the study procedures and provide written informed consent.
- Willing to participate in a single music listening session lasting approximately 25-30 minutes.
- Able to complete self-report questionnaires before and after the intervention.
Exclusion Criteria:
- Self-reported history of diagnosed psychiatric disorders (e.g., major depressive disorder, anxiety disorders, psychotic disorders).
- Current use of psychotropic medications that may significantly affect mood or anxiety.
- Self-reported hearing impairment that could interfere with music listening.
- Self-reported cardiovascular conditions or other medical conditions that could affect heart rate measurements.
- Participation in other psychological or behavioral intervention studies within the past 30 days.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Eastern Imagery Music Therapy Group
Participants assigned to this arm listen to a curated music program accompanied by verbal guidance generated by a large language model.
The verbal guidance is designed to evoke Eastern aesthetic imagery and is delivered during a single 25-30 minute music listening session.
|
Participants listen to a curated music program accompanied by verbal guidance generated by a large language model.
The verbal guidance is designed to evoke Eastern aesthetic imagery and is delivered by a researcher during a single 25-30 minute music listening session in a quiet setting.
|
|
Active Comparator: Standard Music Therapy Group
Participants assigned to this arm listen to music accompanied by standard relaxation-oriented verbal guidance commonly used in music therapy practice.
The intervention is delivered during a single 25-30 minute music listening session.
|
Participants listen to music accompanied by standard relaxation-oriented verbal guidance commonly used in music therapy practice.
The guidance is delivered during a single 25-30 minute music listening session in a quiet setting.
|
|
Active Comparator: Music-Only Relaxation Group
Participants assigned to this arm listen to relaxing music without any verbal guidance during a single 25-30 minute session.
|
Participants listen to relaxing music without any verbal guidance during a single 25-30 minute session in a quiet setting.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in State Anxiety Score
Time Frame: Immediately before and immediately after the single 25-30 minute music listening session
|
State anxiety is assessed using the State subscale of the State-Trait Anxiety Inventory (STAI-S), a validated self-report questionnaire consisting of 20 items.
Scores range from 20 to 80, with higher scores indicating greater state anxiety.
The primary outcome is the change in STAI-S score from before to immediately after the intervention.
|
Immediately before and immediately after the single 25-30 minute music listening session
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Positive Affect Score
Time Frame: Immediately before and immediately after the single 25-30 minute music listening session
|
Positive affect is measured using the Positive Affect subscale of the Positive and Negative Affect Schedule (PANAS).
The subscale consists of 10 items assessing positive emotional states, with higher scores indicating greater positive affect.
The outcome is defined as the change in positive affect score from before to immediately after the intervention.
|
Immediately before and immediately after the single 25-30 minute music listening session
|
|
Change in Negative Affect Score
Time Frame: Immediately before and immediately after the single 25-30 minute music listening session
|
Negative affect is measured using the Negative Affect subscale of the Positive and Negative Affect Schedule (PANAS).
The subscale consists of 10 items assessing negative emotional states, with higher scores indicating greater negative affect.
The outcome is defined as the change in negative affect score from before to immediately after the intervention.
|
Immediately before and immediately after the single 25-30 minute music listening session
|
|
Change in Heart Rate
Time Frame: Immediately before and immediately after the single 25-30 minute music listening session
|
Heart rate is recorded as an objective physiological indicator of autonomic arousal using a smartphone-based photoplethysmography method.
The outcome is defined as the change in mean heart rate measured immediately before and immediately after the intervention.
|
Immediately before and immediately after the single 25-30 minute music listening session
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Wen Li, PhD, Aba Teachers College
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- USM-JEPeM-22120811
- USM/JEPeM/22120811 (Registry Identifier: Universiti Sains Malaysia Human Research Ethics Committee (JEPeM))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Anxiety
-
University of CalabriaNot yet recruitingAnxiety | Anxiety Disease | Anxiety and Distress | Public Speaking AnxietyItaly
-
Clinica Alemana de SantiagoUniversidad del DesarrolloRecruitingAnxiety | Induction of Anesthesia | Anxiety Preoperative | Technology Use | Child Anxiety | Anesthesia Care | Anxiety After SurgeryChile
-
Boston Medical CenterPatient-Centered Outcomes Research Institute; Boston University; Johns Hopkins... and other collaboratorsCompletedAnxiety Disorders | Anxiety | Anxiety Symptoms | Child Anxiety | Anxiety, Mild to Moderate | Pediatric Anxiety DisordersUnited States
-
AstraZenecaCompletedAnxiety Disorders | Anxiety | Anxiety Neuroses | Anxiety StatesUnited States
-
Abant Izzet Baysal UniversityRecruitingAnxiety | Parental AnxietyTurkey (Türkiye)
-
Yale UniversityNational Institute of Mental Health (NIMH)CompletedGeneralized Anxiety Disorder | Anxiety Disorder of Childhood | Separation Anxiety Disorder of Childhood | Social Anxiety Disorder of ChildhoodUnited States
-
Florida State UniversityRecruitingAnxiety | Generalized Anxiety Disorder (GAD) | WorryingUnited States
-
Ann & Robert H Lurie Children's Hospital of ChicagoUniversity of California, Los Angeles; University of CincinnatiActive, not recruitingAnxiety, Separation | Anxiety, Social | Anxiety, GeneralizedUnited States
-
Institut National de la Santé Et de la Recherche...Active, not recruitingAnxiety Disorders | Anxiety | Anxiety and FearFrance
-
Prisma Health-UpstateCompletedAnxiety | Anxiety, Separation | Separation Anxiety | Anxiety Generalized