SadnessNCT06516666
Psychophysiological Effects of Music
A study testing Music in people with Sadness, run by Zhejiang University at 1 site in China.
Trial summary
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. 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?
- Music
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 149 participants
- Where
- 1 siteChina
- Study dates
- 18 Apr 2023to 20 Jun 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 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.
- Conditions
- Sadness
- Being tested
- Music
- Keywords
- music, depression, emotion, heart rate variability
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MusicBehavioural
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.
| 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: 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: 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 the sadness induction, and immediately after the music 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 the sadness induction, and immediately after the music 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 posted24 Jul 2024
- Study start18 Apr 2023
- Primary completion20 Jun 2023
- Study completion20 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 149 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
- NCT06516666
- Sponsor's protocol ID
- Music study in China
- Status last verified
- Jul 2024
- First submitted
- 1 Jul 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
PubMed 7962581Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
PubMed 3397865Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
PubMed 11556941HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
PubMed 14399272Wang X, Lu T, Zhou B, Chen W, Zheng J, Chen H, Chen S. Psychophysiological effects of music on sadness in participants with and without depressive symptoms. BMC Complement Med Ther. 2025 Feb 26;25(1):77. doi: 10.1186/s12906-025-04824-y.
PubMed 40011873
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychophysiological Effects of Music on Sadness in Depressed and Non-Depressed Participants
- ClinicalTrials.gov ID
- NCT06516666
- Acronym / sponsor ID
- Music study in China
- Conditions
- Sadness
- Keywords
- music, depression, emotion, heart rate variability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 18 Apr 2023 (actual)
- Primary completion
- 20 Jun 2023 (actual)
- Study completion
- 20 Jun 2023 (actual)
- First posted
- 24 Jul 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Depressed group | Experimental | 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: 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 |
|---|---|---|
| MusicParticipants 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. | 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 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).
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.
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 24 Jul 2024.
- Background: PubMed 7962581Bradley MM, Lang PJ. Measuring emotion: the Self-Assessment Manikin and the Semantic Differential. J Behav Ther Exp Psychiatry. 1994 Mar;25(1):49-59. doi: 10.1016/0005-7916(94)90063-9.
- Background: PubMed 3397865Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol. 1988 Jun;54(6):1063-70. doi: 10.1037//0022-3514.54.6.1063.
- Background: PubMed 11556941Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Background: PubMed 14399272HAMILTON M. A rating scale for depression. J Neurol Neurosurg Psychiatry. 1960 Feb;23(1):56-62. doi: 10.1136/jnnp.23.1.56. No abstract available.
- Derived from this study: PubMed 40011873Wang X, Lu T, Zhou B, Chen W, Zheng J, Chen H, Chen S. Psychophysiological effects of music on sadness in participants with and without depressive symptoms. BMC Complement Med Ther. 2025 Feb 26;25(1):77. doi: 10.1186/s12906-025-04824-y.
- Individual participant dataSharing planned: No
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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 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 24 Jul 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 the sadness induction, and immediately after the music 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?
On the ClinicalTrials.gov record for NCT06516666, which also lists 5 linked publications.
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 24 Jul 2024.