StressNCT04454736
Psychobiological Responses to Choral Singing in Mentally Ill and Healthy Children and Adolescents
A study testing "Amateur" Group Singing and "Professional" Group Singing in people with Stress, run by University of Salzburg at 3 sites in Austria.
Trial summary
Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase), immune (salivary immunoglobulin A/s-IgA), and… Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- "Amateur" Group Singing and "Professional" Group Singing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 3 sitesAustria
- Study dates
- 1 Aug 2021to Jul 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Written consent to study participation;
- Gender: male, female, different;
- Age: children and adolescents aged ≥ 10 and ≤ 18 years;
- Diagnosis of a psychiatric disorder according to ICD-10;
- Patients are admitted regardless of medication status and are allowed to the medication will continue to be used during the study;
- Additional therapies and medication are recorded and are not an exclusion criterion;
Show all 11Show fewer
- Musical skills or a certain musical background are not required
- Written consent to study participation;
- Gender: male, female, different;
- Age: children and adolescents aged ≥ 10 and ≤ 18 years;
- Musical skills or a certain musical background are not required
Who cannot join
- Age: children and adolescents aged <10 years and > 18 years;
- Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize;
- Patients with acute externalizing behavior or self-harm/suicidality;
- Existing alcohol addiction or abuse of illegal drugs;
- Age: children and adolescents aged <10 years and > 18 years
- Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize
Trial locations and contacts
3 sites in 1 country.
Austria3 sites, 3 recruiting
- Recruiting
Salzburger Landeskliniken, Universitätsklinik für Kinder- und Jugendpsychiatrie
Salzburg, 5020
Leonhard Thun-Hohenstein, Prof.Dr., +43 (0) 57255 ext. 34201, l.thun-hohenstein@salk.at
Leonhard Thun-Hohenstein, Prof. Dr.
- Recruiting
University Mozarteum Salzburg/University of Salzburg
Salzburg, 5020
Katarzyna A Grebosz-Haring, Dr., +43 - 662 - 8044 - 2370, katarzyna.grebosz-haring@sbg.ac.at
Katarzyna A Grebosz-Haring, Dr.
- Recruiting
University of Vienna
Vienna, 1010
Urs M Nater, Prof. Dr., +43 1 4277 ext. 47220, urs.nater@univie.ac.at
Anja C Feneberg, MSc
About this study
Official title: Psychological and Biological Responses to Choral Singing in Mentally Ill, Socially Underprivileged and Privileged Healthy Children and Adolescents: An Open, Single-Arm, Controlled Study
Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase), immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood, social contacts, emotional and social competence, self-esteem, and quality of life) responses in mentally ill and healthy children and adolescents (N=135, age range 10 -18).
Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three hour creative workshops every two weeks.
Read the detailed description
Background: Biopsychological responses to music-related activities (MRA) were examined in various naturalistic settings in adults. Group singing in particular seems to be associated with positive biopsychological outcomes. There is also an emerging view that MRA may play an important role for youth with mental disorders. However, longitudinal research on biopsychological responses to MRA in different clinical and healthy populations among children and adolescents is lacking.
Method: Children and adolescents (age range 10-18) under psychiatric treatment at the Department of Child and Adolescents Psychiatry in Salzburg (n=45), healthy children and adolescents from a school in Salzburg (n=45), and members from the Vienna Boys Choir (n=45) in Austria will be recruited to take part in the study. Subjective measures (mood, stress experience) will be taken pre- and post singing sessions once a week throughout six months. Additionally, salivary biomarkers (cortisol, alpha amylase and IgA), social contacts, and quality of life are assessed. Emotional competence, social competence, self-esteem, and chronic stress levels are measured at the beginning, after three months, at the end, and in a follow-up of the study.
The group of child and adolescent psychiatry taking part in the creative workshops will be additionally assessed via questionnaires regarding emotional regulation, self-esteem, and art experience before and after every workshop. Furthermore, some individuals of the child and adolescent psychiatry group will undergo fMRI evaluation of the brain before and after completion of all creative interventions.
Conclusion: Singing and other creative activities are suggested to benefit mental and physical health in children and adolescents. However, despite the current knowledge, the researchers must better understand the biopsychological mechanisms underlying choral singing in order to determine its full potential, particularly for vulnerable populations. This is the first study to investigate this issue in this population.
- Conditions
- Stress
- Being tested
- "Amateur" Group Singing, "Professional" Group Singing
- Keywords
- Mental health, Youth, Singing, Music, Stress, Cortisol, Alpha Amylase, Immunoglobulin A
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Amateur" Group SingingBehavioural
45-minute singing session led by a professional choirmaster without a therapeutic background once a week
"Professional" Group SingingBehavioural
120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.
| Study group | Role | What they receive |
|---|---|---|
| SBGmentdis | Experimental | Children and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria Receives: Behavioral: "Amateur" Group Singing |
| SBGhealthy | Experimental | Healthy children and adolescents from schools in Salzburg, Austria Receives: Behavioral: "Amateur" Group Singing |
| VIEhealthy | Experimental | Members from the Vienna Boys Choir, Austria Receives: Behavioral: "Professional" Group Singing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months
Biological Stress Marker: Salivary Cortisol
Measured: every two weeks pre- and post singing sessions for six months
Change Short-Term Immune Function from pre- to post singing session over six months
Biological Marker: Salivary Immunoglobulin A
Measured: every two weeks pre- and post singing sessions for six months
Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months
Biological Stress Marker: Hair Cortisol
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months
Salivary Alpha-Amylase
Measured: every two weeks pre- and post singing sessions for six months
Secondary outcomes (16)
Psychological Stress
Stress and Coping Questionnaire for Children and Adolescents (SSKJ 3-8 R; Lohaus, Eschenbeck, Kohlmann, \& Klein-Heßling, 2018)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Mood
Multidimensional Mood State Questionnaire (MDBF, short version; Steyer, Notz, Schwenkmezger, \& Eid, 1997)
Measured: every week pre- and post singing sessions for six months
Emotional Skills
Emotional Competence Questionnaire (EKF; Rindermann, 2009)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Self-Esteem
Selbstwertinventar für Kinder und Jugendliche (SEKJ; Schöne \& Stiensmeier-Pelster, 2016)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Life Quality
Pediatric Quality of Life Inventory (PEDsQL; Varni, 2001)
Measured: once a month for six months
Performance Anxiety
Das State-Trait-Angstinventar (STAI-T adapted; Laux, Glanzmann, Schaffner, \& Spielberger 1981)
Measured: once at the beginning of the study, once after 6 months
Social Skills
Strengths and Difficulties Questionnaire (SDQ; Goodman, 1997)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Evaluation of the choir session
Liking of the session, liking of the songs, familiarity with the songs (5-point Likert scale; Higher scores mean a better outcome)
Measured: every week post singing sessions for six months
Chronical Stress
Fragebogen zu chronischem Stress im Kindesalter (CSiK; Richartz, Hoffmann, \& Sallen, 2009)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Stress Perception
Visual Analogue Scale (VAS; 0-100; higher score means a worse outcome)
Measured: every week pre- and post singing sessions for six months
Prosocial Behavior
Social Network Map (Tracey \& Whittaker, 1990)
Measured: every two weeks post singing sessions for six months
Psychological Stability (parents view)
Child Behavior Checklist (CBCL; Achenbach \& Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Psychological Stability (children view)
Youth Self-Report (YSR; Achenbach \& Arbeitsgruppe Deutsche Child Behavior Checklist, 1994)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Emotional Control
Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ; Grob \& Smolenski, 2005)
Measured: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability
JTCI Junior Temperament and Character Inventory in Children and Adolescents Psychiatry Group Questionnaire
Measured: At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders
Current emotional state
Positive and negative affect schedule (PANAS)
Measured: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Aug 2021
- Primary completionDec 2022 (estimated)
- Study completionJul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Salzburg
- Sponsor type
- University, hospital or other
- Collaborators
- Universität Mozartuem Salzburg, Salzburger Landeskliniken, Paracelsus Medical University, University of Vienna
- Responsible party
- Principal investigator, Katarzyna Grebosz-Haring, University of Salzburg
- Investigators
- Katarzyna Grebosz-Haring, Dr., Principal investigator, University Mozarteum Salzburg, University of SalzburgLeonhard Thun-Hohenstein, Prof. Dr., Principal investigator, Salzburger Landeskliniken Betriebsges.m.b.H.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454736
- Sponsor's protocol ID
- Grebosz-Haring SingingStudy
- Status last verified
- May 2022
- First submitted
- 25 Feb 2020
- Last updated
- 19 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.
PubMed 30582039Grebosz-Haring, K., Thun-Hohenstein, L. (2020). Singing for Health and Wellbeing in Children and Adolescents with Mental Disorders. In R. Heydon, D. Fancourt, A. Cohen (Eds.), The Routledge Companion to Interdisciplinary Studies in Singing: Vol 3 Wellbeing. London: Routledge.
Linnemann, A., Schnersch, A., Nater, U. M. (2017). Testing the beneficial effects of singing in a choir on mood and stress in a longitudinal study: The role of social contacts. Musicae Scientiae, 21(2), 195-212.
Ali N, Nater UM. Salivary Alpha-Amylase as a Biomarker of Stress in Behavioral Medicine. Int J Behav Med. 2020 Jun;27(3):337-342. doi: 10.1007/s12529-019-09843-x.
PubMed 31900867
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Biological Responses to Choral Singing in Mentally Ill, Socially Underprivileged and Privileged Healthy Children and Adolescents: An Open, Single-Arm, Controlled Study
- ClinicalTrials.gov ID
- NCT04454736
- Acronym / sponsor ID
- Grebosz-Haring SingingStudy
- Conditions
- Stress
- Keywords
- Mental health, Youth, Singing, Music, Stress, Cortisol, Alpha Amylase, Immunoglobulin A
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- University of SalzburgUniversity, hospital or other
- Collaborators
- Universität Mozartuem Salzburg, Salzburger Landeskliniken, Paracelsus Medical University, University of Vienna
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Jul 2023 (estimated)
- First posted
- 1 Jul 2020 (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.
Interventional, three-armed, open, monocentric, medium-term follow-up, pre-test-post-test design, controlled, parallel group study to investigate the effects of a group singing intervention on neuroendocrine (hair cortisol, salivary cortisol, salivary alpha amylase), immune (salivary immunoglobulin A/s-IgA), and psychological (psychological stress, mood, social contacts, emotional and social competence, self-esteem, and quality of life) responses in mentally ill and healthy children and adolescents (N=135, age range 10 -18).
Additionally, the child and adolescent psychiatry group (age range 13-18) takes part in three hour creative workshops every two weeks.
Detailed description
Background: Biopsychological responses to music-related activities (MRA) were examined in various naturalistic settings in adults. Group singing in particular seems to be associated with positive biopsychological outcomes. There is also an emerging view that MRA may play an important role for youth with mental disorders. However, longitudinal research on biopsychological responses to MRA in different clinical and healthy populations among children and adolescents is lacking.
Method: Children and adolescents (age range 10-18) under psychiatric treatment at the Department of Child and Adolescents Psychiatry in Salzburg (n=45), healthy children and adolescents from a school in Salzburg (n=45), and members from the Vienna Boys Choir (n=45) in Austria will be recruited to take part in the study. Subjective measures (mood, stress experience) will be taken pre- and post singing sessions once a week throughout six months. Additionally, salivary biomarkers (cortisol, alpha amylase and IgA), social contacts, and quality of life are assessed. Emotional competence, social competence, self-esteem, and chronic stress levels are measured at the beginning, after three months, at the end, and in a follow-up of the study.
The group of child and adolescent psychiatry taking part in the creative workshops will be additionally assessed via questionnaires regarding emotional regulation, self-esteem, and art experience before and after every workshop. Furthermore, some individuals of the child and adolescent psychiatry group will undergo fMRI evaluation of the brain before and after completion of all creative interventions.
Conclusion: Singing and other creative activities are suggested to benefit mental and physical health in children and adolescents. However, despite the current knowledge, the researchers must better understand the biopsychological mechanisms underlying choral singing in order to determine its full potential, particularly for vulnerable populations. This is the first study to investigate this issue in this population.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SBGmentdis | Experimental | Behavioral: "Amateur" Group SingingChildren and adolescents with mental disorders at the Department of Child and Adolescents Psychiatry in Salzburg, Austria |
| SBGhealthy | Experimental | Behavioral: "Amateur" Group SingingHealthy children and adolescents from schools in Salzburg, Austria |
| VIEhealthy | Experimental | Behavioral: "Professional" Group SingingMembers from the Vienna Boys Choir, Austria |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (11 listed)
- Written consent to study participation;
- Gender: male, female, different;
- Age: children and adolescents aged ≥ 10 and ≤ 18 years;
- Diagnosis of a psychiatric disorder according to ICD-10;
- Patients are admitted regardless of medication status and are allowed to the medication will continue to be used during the study;
Key exclusion criteria (6 listed)
- Age: children and adolescents aged <10 years and > 18 years;
- Criteria that prevent an application: hearing loss, states of confusion, inability to verbalize;
- Patients with acute externalizing behavior or self-harm/suicidality;
- Existing alcohol addiction or abuse of illegal drugs;
- Age: children and adolescents aged <10 years and > 18 years
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 |
|---|---|---|
| "Amateur" Group Singing45-minute singing session led by a professional choirmaster without a therapeutic background once a week | Behavioural | SBGhealthy, SBGmentdis |
| "Professional" Group Singing120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week. | Behavioural | VIEhealthy |
Primary outcome
Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months
Time frame: every two weeks pre- and post singing sessions for six months
Biological Stress Marker: Salivary Cortisol
Change Short-Term Immune Function from pre- to post singing session over six months
Time frame: every two weeks pre- and post singing sessions for six months
Biological Marker: Salivary Immunoglobulin A
Change from Baseline Chronic Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) at three and six months
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Biological Stress Marker: Hair Cortisol
Change Short-Term Neuroendocrine Stress (Autonomic Nervous System) from pre- to post singing session over six months
Time frame: every two weeks pre- and post singing sessions for six months
Salivary Alpha-Amylase
16 secondary outcomes
Psychological Stress
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Mood
Time frame: every week pre- and post singing sessions for six months
Emotional Skills
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Self-Esteem
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Life Quality
Time frame: once a month for six months
Performance Anxiety
Time frame: once at the beginning of the study, once after 6 months
Social Skills
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Evaluation of the choir session
Time frame: every week post singing sessions for six months
Chronical Stress
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Stress Perception
Time frame: every week pre- and post singing sessions for six months
Prosocial Behavior
Time frame: every two weeks post singing sessions for six months
Psychological Stability (parents view)
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Psychological Stability (children view)
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Emotional Control
Time frame: at the beginning of the study, after three months, at the end of the study after six months, at a follow-up after three months, at a follow up after six months
Specific personality and character traits such as curiosity, reward dependency, cooperativity, and self-steering ability
Time frame: At the beginning of creative workshops, and at a follow-up after three months in the group of children and adolescents with psychiatric disorders
Current emotional state
Time frame: Pre and post every creative workshop in the group of children and adolescents with psychiatric disorders
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
- Background: PubMed 30582039Grebosz-Haring K, Thun-Hohenstein L. Effects of group singing versus group music listening on hospitalized children and adolescents with mental disorders: A pilot study. Heliyon. 2018 Dec 17;4(12):e01014. doi: 10.1016/j.heliyon.2018.e01014. eCollection 2018 Dec.
- BackgroundGrebosz-Haring, K., Thun-Hohenstein, L. (2020). Singing for Health and Wellbeing in Children and Adolescents with Mental Disorders. In R. Heydon, D. Fancourt, A. Cohen (Eds.), The Routledge Companion to Interdisciplinary Studies in Singing: Vol 3 Wellbeing. London: Routledge.
- BackgroundLinnemann, A., Schnersch, A., Nater, U. M. (2017). Testing the beneficial effects of singing in a choir on mood and stress in a longitudinal study: The role of social contacts. Musicae Scientiae, 21(2), 195-212.
- Background: PubMed 31900867Ali N, Nater UM. Salivary Alpha-Amylase as a Biomarker of Stress in Behavioral Medicine. Int J Behav Med. 2020 Jun;27(3):337-342. doi: 10.1007/s12529-019-09843-x.
- Individual participant dataSharing planned: Yes
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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.
Katarzyna Grebosz-Haring, Dr. principal investigator
University Mozarteum Salzburg, University of Salzburg
Leonhard Thun-Hohenstein, Prof. Dr. principal investigator
Salzburger Landeskliniken Betriebsges.m.b.H.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Amateur" Group Singing and "Professional" Group Singing in people with Stress, run by University of Salzburg at 3 sites in Austria.
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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Katarzyna Grebosz-Haring, Dr. (+43 - 662 - 8044 - 2370, katarzyna.grebosz-haring@sbg.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change Short-Term Neuroendocrine Stress (Hypothalamic-Pituitary-Adrenal Axis) from pre- to post singing session over six months (time frame: every two weeks pre- and post singing sessions for six months). 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 NCT04454736, which also lists 4 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 19 May 2022.