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临床试验/NCT06516666
NCT06516666已完成不适用

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

Zhejiang University1 个研究点 分布在 1 个国家目标入组 149 人开始时间: 2023年4月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
149
试验地点
1
主要终点
Revision of Positive Affect and Negative Affect Scale (PANAS-R)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

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

时间窗: 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.

Self-Assessment Manikin (SAM)

时间窗: 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).

Mean of Normal-to-Normal Intervals (MeanNN)

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Shulin Chen

Professor

Zhejiang University

研究点 (1)

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