- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06581445
Psychophysiological Effects of Birdsongs VS Music
Psychophysiological Effects of Birdsongs on Sadness: Compared With Music Between Depressed and Non-Depressed Participants
The main goal of this study is to learn the psychophysiological effects of birdsongs on sadness. The main questions it aims to answer are:
- Can birdsongs alleviate sadness in a short term?
- Can birdsongs have greater impact on sadness than music?
- Can birdsongs alleviate sadness for both non-depressed and depressed participants?
Researchers will compare birdsongs to music (a active control) to see if birdsongs works to reduce sadness and also examined the psychophysiological effects of birdsongs in depressed and non-depressed participants.
Participants will:
go through the following stages: baseline, neutral control, 1st sadness induction, 1st intervention, calculation task, 2nd sadness induction, and 2nd intervention.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310058
- Zhejiang University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Single Group 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. |
The participants listened to a clip of birdsongs from laughing thrushes.
The participants listened to a cheerful Cuckoo Waltz music.
|
|
Experimental: Non-depressed group
Those with PHQ-9 scores < 5 or HAM-D scores ≤ 8 were classified into the non-depressed group.
|
The participants listened to a clip of birdsongs from laughing thrushes.
The participants listened to a cheerful Cuckoo Waltz music.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
|
Self-Assessment Manikin (SAM)
Time Frame: Immediately after the baseline, immediately after the neutral control, immediately after each sadness induction, and immediately after each 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).
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Immediately after the baseline, immediately after the neutral control, immediately after each sadness induction, and immediately after each intervention.
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Revision of Positive Affect and Negative Affect Scale (PANAS-R)
Time Frame: Immediately after the baseline, immediately after the neutral control, immediately after each sadness induction, and immediately after each 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.
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Immediately after the baseline, immediately after the neutral control, immediately after each sadness induction, and immediately after each intervention.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Effects of Birdsongs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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