NCT06581445

Brief Summary

The main goal of this study is to learn the psychophysiological effects of birdsongs on sadness. The main questions it aims to answer are:

  1. 1.Can birdsongs alleviate sadness in a short term?
  2. 2.Can birdsongs have greater impact on sadness than music?
  3. 3.Can birdsongs alleviate sadness for both non-depressed and depressed participants?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 16, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

7 months

First QC Date

August 30, 2024

Last Update Submit

August 30, 2024

Conditions

Keywords

Birdsongsmusicsadnessdepressive symptomspsychophysiological effects

Outcome Measures

Primary Outcomes (4)

  • Self-Assessment Manikin (SAM)

    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 each sadness induction, and immediately after each intervention.

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

    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 each sadness induction, and immediately after each intervention.

  • Mean of Normal-to-Normal Intervals (MeanNN)

    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)

    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.

Study Arms (2)

Depressed group

EXPERIMENTAL

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.

Behavioral: BirdsongsBehavioral: Music

Non-depressed group

EXPERIMENTAL

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

Behavioral: BirdsongsBehavioral: Music

Interventions

BirdsongsBEHAVIORAL

The participants listened to a clip of birdsongs from laughing thrushes.

Depressed groupNon-depressed group
MusicBEHAVIORAL

The participants listened to a cheerful Cuckoo Waltz music.

Depressed groupNon-depressed group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhejiang University

Hangzhou, Zhejiang, 310058, China

Location

MeSH Terms

Conditions

Depression

Interventions

Music Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Sensory Art TherapiesComplementary TherapiesTherapeuticsRehabilitationAftercareContinuity of Patient CarePatient CarePsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were told that this experiment was to examine the different effects between video stimuli and audio stimuli.
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 30, 2024

First Posted

September 3, 2024

Study Start

May 16, 2023

Primary Completion

December 7, 2023

Study Completion

December 7, 2023

Last Updated

September 3, 2024

Record last verified: 2024-08

Locations