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Completed

NCT Number: NCT07359950

Film-Based Music Therapy With AI-Generated Verbal Guidance for Anxiety in Young Adults

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.

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Key information

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aba Teachers College

Aba, Sichuan, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Music Listening With AI-Generated Eastern Imagery Verbal Guidance

Behavioral

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.

Music Listening With Standard Verbal Guidance

Behavioral

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.

Music-Only Relaxation

Behavioral

Participants listen to relaxing music without any verbal guidance during a single 25-30 minute session in a quiet setting.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Wen Li

Other

Registry information

Official study title

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

Acronym: EAST-MUSIC

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 22, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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