Anxiety Disorders and SymptomsNCT05510921
Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology
A study testing Minimalist music group and Minimalist music + birdsongs group in people with Anxiety Disorders and Symptoms, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial summary
This project aims to investigate the effects of an intervention involving minimalist piano music and bird singing on the anxiety of nursing professionals working in the Oncology sector of a hospital. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms
- What is being tested?
- Minimalist music group and Minimalist music + birdsongs group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2022to 31 Mar 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Nursing professionals working in oncology Unit
- Over 18 years old
Who cannot join
- Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652 900
About this study
Official title: Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology: a Randomized Clinical Trial
This project aims to investigate the effects of an intervention involving minimalist piano music and bird singing on the anxiety of nursing professionals working in the Oncology sector of a hospital.
Read the detailed description
The demand for care with mental health of nursing professionals is increasingly present, considering the high rate of anxiety symptoms presented by the teams providing health care within hospitals. Oncology is one of the sectors where professionals have constant contact with situations of suffering and death, being a place where the enlargement of therapeutic tools for handling anxiety symptoms may bring benefits. Scientific literature has never described the effectiveness of works with minimalist music and birds singing used simultaneously with anxiety relief resources. Objective: Assess the effects of music intervention, with minimalist repertoire, with or without association to birds singing over anxiety of nursing professionals that work in Oncology. Method: Randomized Clinical controlled trial. The study will be performed in the Oncology sector of Israeli Hospital Albert Einstein located in São Paulo, Brazil and the population consists in 100 nursing professionals. The intervention will consist in a musical part, especially developed for this study and in recording of birds singing, played live for each one of the participants, individually with 10 to 15 minutes duration. The instrument for anxiety assessment chosen for this project is short-form of state-trait anxiety inventory (STAI-S-6). The project was approved by the research ethics committee, whose identification number on Plataforma Brasil (CAAE) is 59498222.6.0000.0071
- Conditions
- Anxiety Disorders and Symptoms
- Being tested
- Minimalist music group, Minimalist music + birdsongs group
- Keywords
- Nursing professionals, Anxiety, Oncology, Music, Nature
- Medical subject headings
- Anxiety Disorders, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Minimalist music groupOther
Participants in this group will listen individually a live session of minimalist music piano piece, in a break room in the oncology sector, lasting between 10 and 15 minutes.
Minimalist music + birdsongs groupOther
Participants in this group will listen individually a live session of minimalist music piano piece with the superposition of bird song sounds, in a break room in the oncology sector, lasting between 10 and 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | The control group will not receive any intervention |
| Minimalist music group | Experimental | a live session of minimalist music piano piece Receives: Other: Minimalist music group |
| Minimalist music plus birdsongs group | Experimental | a live session of minimalist music piano piece with the superposition of bird song sounds Receives: Other: Minimalist music + birdsongs group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline levels of anxiety at immediately post intervention
To assess the anxiety of the study participant, the reduced scale of trait anxiety (STAI-S-6), validated in Brazil in a large sample of Brazilians, will be used. There are 6 questions that assess how the individual is feeling at the present moment and can be answered with 4 options on a 4-point Likert scale: 1- almost never; 2- sometimes; 3- frequently; 4- almost always. This gives a score range from 6 to 24. To create scores compatible with the original STAI-S scores, the STAI-6 scores will be divided by 6 and multiplied by 20 to give a range from 20 to 80.STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
Measured: immediately pre intervention and immediately post intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2022
- Study start1 Oct 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Anxiety Disorders and SymptomsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eliseth Ribeiro Leao, Hospital Israelita Albert Einstein
- Investigators
- Eliseth R Leão, PhD, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05510921
- Sponsor's protocol ID
- 5483730
- Status last verified
- Mar 2025
- First submitted
- 19 Aug 2022
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.
PubMed 28241070
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05510921
- Acronym / sponsor ID
- 5483730
- Conditions
- Anxiety Disorders and Symptoms
- Keywords
- Nursing professionals, Anxiety, Oncology, Music, Nature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 22 Aug 2022 (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 project aims to investigate the effects of an intervention involving minimalist piano music and bird singing on the anxiety of nursing professionals working in the Oncology sector of a hospital.
Detailed description
The demand for care with mental health of nursing professionals is increasingly present, considering the high rate of anxiety symptoms presented by the teams providing health care within hospitals. Oncology is one of the sectors where professionals have constant contact with situations of suffering and death, being a place where the enlargement of therapeutic tools for handling anxiety symptoms may bring benefits. Scientific literature has never described the effectiveness of works with minimalist music and birds singing used simultaneously with anxiety relief resources. Objective: Assess the effects of music intervention, with minimalist repertoire, with or without association to birds singing over anxiety of nursing professionals that work in Oncology. Method: Randomized Clinical controlled trial. The study will be performed in the Oncology sector of Israeli Hospital Albert Einstein located in São Paulo, Brazil and the population consists in 100 nursing professionals. The intervention will consist in a musical part, especially developed for this study and in recording of birds singing, played live for each one of the participants, individually with 10 to 15 minutes duration. The instrument for anxiety assessment chosen for this project is short-form of state-trait anxiety inventory (STAI-S-6). The project was approved by the research ethics committee, whose identification number on Plataforma Brasil (CAAE) is 59498222.6.0000.0071
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –The control group will not receive any intervention |
| Minimalist music group | Experimental | Other: Minimalist music groupa live session of minimalist music piano piece |
| Minimalist music plus birdsongs group | Experimental | Other: Minimalist music + birdsongs groupa live session of minimalist music piano piece with the superposition of bird song sounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Nursing professionals working in oncology Unit
- Over 18 years old
Key exclusion criteria (1 listed)
- Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.
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 |
|---|---|---|
| Minimalist music groupParticipants in this group will listen individually a live session of minimalist music piano piece, in a break room in the oncology sector, lasting between 10 and 15 minutes. | Other | Minimalist music group |
| Minimalist music + birdsongs groupParticipants in this group will listen individually a live session of minimalist music piano piece with the superposition of bird song sounds, in a break room in the oncology sector, lasting between 10 and 15 minutes. | Other | Minimalist music plus birdsongs group |
Primary outcome
Change from baseline levels of anxiety at immediately post intervention
Time frame: immediately pre intervention and immediately post intervention.
To assess the anxiety of the study participant, the reduced scale of trait anxiety (STAI-S-6), validated in Brazil in a large sample of Brazilians, will be used. There are 6 questions that assess how the individual is feeling at the present moment and can be answered with 4 options on a 4-point Likert scale: 1- almost never; 2- sometimes; 3- frequently; 4- almost always. This gives a score range from 6 to 24. To create scores compatible with the original STAI-S scores, the STAI-6 scores will be divided by 6 and multiplied by 20 to give a range from 20 to 80.STAI scores are commonly classified as "no or low anxiety" (20-37), "moderate anxiety" (38-44), and "high anxiety" (45-80).
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 11 Mar 2025.
- Background: PubMed 28241070Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.
- 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.
Eliseth R Leão, PhD principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Minimalist music group and Minimalist music + birdsongs group in people with Anxiety Disorders and Symptoms, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
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 2 inclusion and 1 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 11 Mar 2025. 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 Brazil. 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?
Change from baseline levels of anxiety at immediately post intervention (time frame: immediately pre intervention and immediately post intervention.). 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 NCT05510921, which also lists 1 linked publication.
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 11 Mar 2025.