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Completed

NCT Number: NCT06516666

Psychophysiological Effects of Music

This study employed a repeated measure between-subjects design. Two groups (i.e., depressed group and non-depressed group) of participants were recruited. Each participant experienced four stages: baseline, neutral control, sadness induction, and music intervention. The outcome variables were self-reported emotion and Heart Rate Variability features. Emotions were reported at the end of every stage. Electrocardiogram signals were recorded throughout the experiment.

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Key information

Conditions

Sadness Behavior Behavioral Symptoms Depression

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shulin Chen

Hangzhou, Zhejiang, 310058, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Aged 18-30 years
  • Right-handed
  • No recent illness or medication use
  • No history of neurological or psychiatric disorders
  • Normal or corrected-to-normal visual acuity (myopic participants wore glasses)
  • Normal hearing

Exclusion criteria

  • Incapable of giving written informed consent to this study
  • Acute high suicide risk at baseline assessment
  • Psychosis

Treatment and study plan

Music

Behavioral

Participants went through four stages. In the rest stage, they were instructed to relax. In the neutral control stage, they watched an informative video about plastic injection molding. In the sadness induction stage, they viewed sad clips from either Hachi: A Dog's Tale or My Brother and Sister, with the order randomized across participants. In the music intervention stage, they listened to the cheerful Cuckoo Waltz. Each stage lasted for about 6 minutes.

The interventions for the two groups were exactly same.

PS: On the basis of the PHQ-9, this HAMD interview was conducted to further group the participants. So, following the experimental protocol, participants who scored ≥ 5 on the PHQ-9 measure underwent the HAMD interview, while the remaining individuals were simply interviewed about their feelings during the experiment.

Primary outcomes

  1. Self-Assessment Manikin (SAM)

    Time frame: Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.

    The SAM scale is a brief and widely used tool for assessing emotional states. The scale is a nonverbal self-report measure of emotion, using a set of cartoon-like manikins. The manikins illustrate nine intensity levels for valence (1 = unpleasant; 9 = pleasant), arousal (1 = calm, 9 = excited), and dominance (1 = controlled; 9 = controlling).

  2. Revision of Positive Affect and Negative Affect Scale (PANAS-R)

    Time frame: Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.

    The PANAS is another widely used scale to measure mood or emotion. The Chinese version of PANAS is comprised of 18 items, with 9 items measuring positive affect (e.g., joyful, inspired) and 9 items measuring negative affect (e.g., sad, fearful). Because participants were required to report their feelings repeatedly in this study, 18 items would be too long and tiresome. The 18 items plus "calmness" were used as 19 options for participants to choose. They needed to select one of the emotion words to tag their strongest emotion for the stage that they had just experienced. This revision of PANAS allowed us to capture the specific emotion type.

  3. Mean of Normal-to-Normal Intervals (MeanNN)

    Time frame: Throughout the whole experiment, an average of 6 minutes for each stage.

    MeanNN refers to the average duration between consecutive normal heartbeats, also named inter-beat interval. A higher MeanNN indicates a lower heart rate.

  4. Standard Deviation of Normal-to-Normal Intervals (SDNN)

    Time frame: Throughout the whole experiment, an average of 6 minutes for each stage.

    SDNN measures the overall variability of heart rate. Higher SDNN values indicate greater variability.

Sponsors and collaborators

Lead sponsor

Zhejiang University

Other

Registry information

Official study title

Psychophysiological Effects of Music on Sadness in Depressed and Non-Depressed Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2024
Registry last updated
Jul 24, 2024

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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