Psychophysiological Effects of Music

July 22, 2024 updated by: Shulin Chen, Zhejiang University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Zhejiang
      • Hangzhou, Zhejiang, China, 310058
        • Shulin Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Depressed group

The participants were categorized into two groups using the Patient Health Questionnaire (PHQ-9) and the 17-item Hamilton Depression Rating Scale (HAM-D). PHQ-9 is a self-report scale. PHQ-9 scores of 5 or higher represent mild and severe depression, while PHQ-9 scores of lower than 5 mean normal condition. HAM-D is a scale administered by a healthcare professional. The cut-off point of the HAM-D scale is 8, which divides normal conditions from depressive conditions. The participants first completed PHQ-9. For those with PHQ-9 scores of 5 or higher, the trained researchers interviewed them and rated their severity of depression on the HAM-D. The participants first completed PHQ-9.

For those with PHQ-9 scores ≥ 5, the trained researchers interviewed them and rated their severity of depression on the HAM-D. Those with HAM-D scores > 8 were classified into the depressed group.

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.

Experimental: Non-depressed group
Those with PHQ-9 scores < 5 or HAM-D scores ≤ 8 were classified into the non-depressed group.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.
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.
Immediately after the baseline, immediately after the neutral control, immediately after the sadness induction, and immediately after the music intervention.
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.
Throughout the whole experiment, an average of 6 minutes for each stage.
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.
Throughout the whole experiment, an average of 6 minutes for each stage.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2023

Primary Completion (Actual)

June 20, 2023

Study Completion (Actual)

June 20, 2023

Study Registration Dates

First Submitted

July 1, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2024

Last Update Submitted That Met QC Criteria

July 22, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • Music study in China

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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