SadnessNCT06581445
Psychophysiological Effects of Birdsongs VS Music
A study testing Birdsongs and Music in people with Sadness, run by Zhejiang University at 1 site in China.
Trial 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. Can birdsongs alleviate sadness in a short term? 2. Can birdsongs have greater impact on sadness than music? 3. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Sadness
- What is being tested?
- Birdsongs and Music
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteChina
- Study dates
- 16 May 2023to 7 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Incapable of giving written informed consent to this study
- Acute high suicide risk at baseline assessment
- Psychosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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?
Read more
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.
Read the detailed description
During the baseline phase, participants were instructed to sit quietly and relax. For the neutral control, they viewed an informative video demonstrating the process of plastic injection molding. As for the sadness induction, they were presented with sad film clips from either Hachi: A Dog\'s Tale or My Brother and Sister. The order of the sad videos was randomized across participants. The intervention stages involved listening to either the cheerful Cuckoo Waltz music or a clip of birdsongs from laughing thrushes. The order of the interventions was randomized as well. The calculation task was employed as a distracter, enabling participants to return to a neutral state. Except for the computational task, the remaining six phases each had a duration of 6 minutes.
- Conditions
- Sadness
- Being tested
- Birdsongs, Music
- Keywords
- Birdsongs, music, sadness, depressive symptoms, psychophysiological effects
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BirdsongsBehavioural
The participants listened to a clip of birdsongs from laughing thrushes.
MusicBehavioural
The participants listened to a cheerful Cuckoo Waltz music.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Birdsongs; Behavioral: Music |
| Non-depressed group | Experimental | Those with PHQ-9 scores < 5 or HAM-D scores ≤ 8 were classified into the non-depressed group. Receives: Behavioral: Birdsongs; Behavioral: Music |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Throughout the whole experiment, an average of 6 minutes for each stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2024
- Study start16 May 2023
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SadnessStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shulin Chen, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06581445
- Sponsor's protocol ID
- Effects of Birdsongs
- Status last verified
- Aug 2024
- First submitted
- 30 Aug 2024
- Last updated
- 3 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effects of Birdsongs on Sadness: Compared With Music Between Depressed and Non-Depressed Participants
- ClinicalTrials.gov ID
- NCT06581445
- Acronym / sponsor ID
- Effects of Birdsongs
- Conditions
- Sadness
- Keywords
- Birdsongs, music, sadness, depressive symptoms, psychophysiological effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 16 May 2023 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 3 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
During the baseline phase, participants were instructed to sit quietly and relax. For the neutral control, they viewed an informative video demonstrating the process of plastic injection molding. As for the sadness induction, they were presented with sad film clips from either Hachi: A Dog\'s Tale or My Brother and Sister. The order of the sad videos was randomized across participants. The intervention stages involved listening to either the cheerful Cuckoo Waltz music or a clip of birdsongs from laughing thrushes. The order of the interventions was randomized as well. The calculation task was employed as a distracter, enabling participants to return to a neutral state. Except for the computational task, the remaining six phases each had a duration of 6 minutes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed group | Experimental | Behavioral: Birdsongs, Behavioral: MusicThe 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. |
| Non-depressed group | Experimental | Behavioral: Birdsongs, Behavioral: MusicThose with PHQ-9 scores < 5 or HAM-D scores ≤ 8 were classified into the non-depressed group. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- Incapable of giving written informed consent to this study
- Acute high suicide risk at baseline assessment
- Psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BirdsongsThe participants listened to a clip of birdsongs from laughing thrushes. | Behavioural | Depressed group, Non-depressed group |
| MusicThe participants listened to a cheerful Cuckoo Waltz music. | Behavioural | Depressed group, Non-depressed group |
Primary outcome
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).
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Birdsongs and Music in people with Sadness, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2024.