Evaluation of the Minimalist Music and Birdsongs in the Anxiety of Nursing Professionals in Oncology: a Randomized Clinical Trial
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Sponsor: Hospital Israelita Albert Einstein

Rubric: 1) Research participant __________ 2) Responsible for consent _________ 
Version 1, May 31st, 2022 
 
(Israeli Institute of Teaching and Research) 
 
RESEARCH PROTOCOL 
 
Evaluation of minimalist music and birdsongs in the  
anxiety of nursing professionals in Oncology. 
Prof. Dr. Eliseth Ribeiro Leão. 
 
 
Free and Informed Consent Form 
Participants aged ≥ 18 years 
 
 
Advisor: Prof. Dra. Eliseth Ribeiro Leao 
Researcher: Fernanda Heleno Migueis Abrahão 
 
Introduction 
You are being invited to voluntarily participate of a study entitled 
“Evaluation of the minimalist music and birdsongs in the anxiety of nursing professionals in 
Oncology”. For you to decide to take part thereof, you will need to know what your participation 
is about, as well as the possibilities of risks and benefits and confirm your participation through 
the signature of this free and informed consent form. 
If you have any question, during or after reading this form, please feel free to enter in contact with 
the researcher in charge for the conduction of the study or with any professional that participates 
of the study who may clarify your questions. 
The decision to take part of the study is voluntary and you can refuse to participate or withdraw 
from the study at any time with no type of consequence whatsoever for your treatment/professional 
relationship with the institution. The purpose of this research is to evaluate a type of musical 
intervention as a resource of relief of anxiety in professionals working in Oncology. 
 
Procedures performed in this protocol 
In this study, the participants will be allocated in three groups: a) control group (without 
intervention); b) intervention group with minimalist music and c) intervention group with 
minimalist music and birdsongs. The randomization process will be performed by the software 
Randomizer®. The interventions will be carried out individually right before and right after each 

Rubric: 1) Research participant __________ 2) Responsible for consent _________ 
Version 1, May 31st, 2022 
intervention, an anxiety evaluation instrument, in the format of a 6-question questionnaire will be 
applied. The intervention and application of the questionnaire last 15 minutes. The participants 
will have access to the results of the research, once the study is finished. 
 
Duties of the participant 
For the realization of this study, it is important that you are present during the 15 minutes of the 
intervention and respond the questionnaire (comprised by 6 questions) before and after the 
intervention. In case you are part of the control group, the questionnaire will be applied twice, with 
a 15-minute interval. 
 
Risks and inconveniences 
This study presents minimum risks. With the purpose to avoid the risk of breach of secrecy and 
confidentiality, the main investigator of this study undertakes to not share any information or 
reaction of the participant during the intervention performed and treat the data anonymously. 
Additionally, there is a risk of discomfort by the participant, and it is ensured that he/she can give 
up at any time of the research. 
 
Benefit of the Study 
There is a possibility of direct benefit to the participants to the extent that, if the intervention shows 
to be effective, it can generate a relief of anxiety and/or feeling of wellbeing. Additionally, there 
is an indirect benefit to the extent that, if the intervention shows to be effective, other persons can 
benefit from the reproduction of this work. 
 
Rights of the Participant 
Your participation is voluntary, and you can withdraw your consent or even discontinue your 
participation at any time, if you wish so, with no penalty and/or loss whatsoever. There will not be 
any cost to you arising from this study, considering that the study will be performed during a period 
that you will be at the hospital, that is, there is no transportation cost, for example. Additionally, 
there is no type of compensation for your participation. 
 

Rubric: 1) Research participant __________ 2) Responsible for consent _________ 
Version 1, May 31st, 2022 
By signing this form, you do not give up any legal right, including the right to seek indemnification 
in case of harm resulting from your participation. 
If you are interested, you may request, at any time, information on the results of the tests performed 
in this study. 
 
Harms 
If an injury or any harm occurs as a result of your participation in this research, full assistance will 
be available with no cost to you, for the time that may be necessary. 
 
Confidentiality 
The study team will have access to your data; however, your anonymity is guaranteed and possible 
scientific publications resulting from this study will not identify you in any circumstance as a 
participant. The data obtained will be treated under strict confidentiality conditions. 
 
Ethics 
This study was approved by the Committee of Ethics in Research (CEP), a group of people that 
care for the protection of the participants of the research and evaluate the studies involving human 
beings in our institution. For any questions, ethical and/or related to rights of the research 
participants, get in contact with the Committee of Ethics in Research of Hospital Albert Einstein 
by the telephone (11) 2151-3729, or by the e-mail cep@einstein.be. The Committee works from 
Monday to Friday, from 7 AM to 5 PM, and is located at the Albert Einstein Education and 
Research Center – Campus Cecilia and Abram Szajman. Rua Comendador Elias Jafet, 755. 
Morumbi – SP, Postal Code: 05653-000,  
Piso L4 – Suite 407-F/407-G. For any question related to the study, please feel free to get in contact 
with the people in charge of the study, Fernanda Abrahão, by the telephone (11) 992987170 or 
Eliseth Leão, by the telephone (11) 21511032. 
Complaints, compliments and suggestions can be forwarded to the Customer Service System 
(SAC) by the telephone (11) 2151-0222 or the form identified as “talk to us” [fale conosco], 
available in the page of clinical research, or personally. 
 
Consent Signatures 

Rubric: 1) Research participant __________ 2) Responsible for consent _________ 
Version 1, May 31st, 2022 
I was informed about all details related to the study that I participated. I will receive a signed, dated 
and initialized page of this Free and Informed Consent Form, being the other signed, dated and 
initialized copy remaining with the researcher. 
 
 
_________________________________________________________________________ 
Research Participant’s Full Name 
 
 
_______________________________________________________ Date: ____/____/____ 
Research Participant’s Signature 
 
 
 
 
_________________________________________________________________________ 
Researcher in Charge Full and Legible Name 
 
 
_______________________________________________________ Date: ____/____/____ 
Researcher in Charge Signature