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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05510921
Other study ID # 5483730
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 1, 2022
Est. completion date May 2023

Study information

Verified date February 2023
Source Hospital Israelita Albert Einstein
Contact Eliseth R. Leão, PhD
Phone 1199618-6489
Email eliseth.leão@einstein.br
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Nursing professionals working in oncology Unit - Over 18 years old Exclusion Criteria: - Nursing professionals who, for whatever reason, are unable to fully participate of the proposed musical intervention.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Minimalist music group
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 group
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.

Locations

Country Name City State
Brazil Hospital Israelita Albert Einstein São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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). immediately pre intervention and immediately post intervention.
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