e-Natureza Blue Care - Impact of Virtual Reality on Pain Perception, Mood States, and Analgesic Use in Patients With Cancer Pain: Randomized Clinical Trial.
Phase: NA
Conditions: Cancer Pain, Palliative Care
Sponsor: Hospital Israelita Albert Einstein

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
 
 Informed Consent Form 
Participants aged > 18 year 
 
 
Introduction 
You are being invited to voluntarily participate in the study entitled e-Natureza 
Blue Care – The impact of virtual reality on pain perception, mood states, and 
analgesic use in patients with oncologic pain: a randomized clinical trial. To 
decide whether you would like to take part, it is important that you understand what 
participation involves, including potential risks and benefits, and confirm your 
agreement by signing this informed consent form. 
If you have any questions after or during the reading of this form, please feel free 
to contact the principal investigator or any member of the study team to address 
your concerns. 
Participation in this study is entirely voluntary. You may choose not to participate or 
to withdraw at any time, without any negative consequences for your treatment or 
professional relationship with the institution. 
The aim of this research is to contribute to the therapeutic arsenal for the treatment 
of cancer patients with chronic pain through the use of immersive virtual reality. 
 
Study Procedures 
Your participation in this study will be divided into two groups: 
Group 
1 
(Control 
Group): 
In this group, you will be asked to complete four questionnaires: a 
sociodemographic and professional background questionnaire, a pain level 
assessment scale, a scale to evaluate your mood and well-being, and a scale to 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
assess your connection with nature. It is estimated that completing these 
questionnaires 
will 
take 
approximately 
20 
minutes. 
Important: In this group, immersive virtual reality (VR) with nature imagery will not 
be used. You will continue to receive only the analgesic treatment prescribed by 
your physician. 
Group 
2 
(Intervention 
Group): 
After completing the same four questionnaires described for Group 1, you will 
participate in an immersive virtual reality experience using VR goggles that display 
natural environments, such as beaches and waterfalls. This experience lasts 
approximately eight minutes. The goggles are sanitized between uses, and 
disposable 
face 
covers 
are 
used 
to 
ensure 
your 
safety. 
All questionnaires will be provided in printed format. After completion and signing, 
they must be returned to the research staff. 
After signing this informed consent form, you will be randomly assigned to one of 
the two groups (Group 1 or Group 2). Regardless of which group you are placed in, 
your medical prescription will remain unchanged, and you will continue with your 
standard 
pain 
management 
therapy. 
Important: There will be no costs or additional charges related to your participation 
in the study.After agreeing to participate and being assigned to a group, you will 
complete a pain assessment using a visual analog scale from zero to ten, where 
zero indicates no pain and ten indicates the worst pain imaginable. You will also 
complete a questionnaire assessing your current mood, well-being, and connection 
with 
nature. 
This 
step 
is 
estimated 
to 
take 
20 
minutes. 
General data such as gender, age, diagnosis, and pain level will be extracted from 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
your medical record by the principal investigator, who is part of the hospital's pain 
management team. 
After 24 hours, regardless of the group to which you were assigned, the principal 
investigator will review your electronic medical record to check for any changes in 
analgesic 
use 
(whether 
increased 
or 
decreased). 
In addition, you will be asked to complete the pain assessment scale and the mood 
and well-being scale again. This stage is expected to take approximately 15 
minutes. 
Risks and Discomforts 
Participants in the study may feel discomfort, such as nausea or dizziness, when 
using the virtual reality goggles. If you feel uncomfortable or experience any 
inconvenience during the study, you may stop your participation at any time without 
any change to the way you receive your treatment. 
Only the researchers will have access to the personal information and data of the 
participants. There is a risk of data leakage and breach of confidentiality, which will 
be minimized by adhering to ethical principles for conducting research with human 
subjects and by not sharing this information through physical or digital means. All 
data will be stored securely within the institution, which uses specific platforms to 
prevent such occurrences and to ensure the safety of patient participation in the 
studies conducted. 
Benefits of the Study 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
The study will allow patients in the intervention group to directly experience the 
benefits provided by virtual reality (VR) and the associated improvements in well-
being resulting from this research. We expect a significant improvement in the 
quality of care and treatment for this patient population, as well as an increase in 
knowledge and related clinical practices. 
On the other hand, patients in the control group will play an essential role in the 
research by completing questionnaires, which will allow comparison of results with 
the standard treatment in use. Thus, they will continue to receive their established 
analgesic treatment, contributing valuable data for the development of new 
therapeutic approaches. 
Alternatives 
to 
Participation 
in 
the 
Study 
Your participation is entirely voluntary. If you choose not to participate in the study, 
your prescribed analgesic therapy will be maintained, with options proposed by 
your medical team. 
Participant 
Rights 
Your participation is voluntary, and you may withdraw your consent or discontinue 
participation at any time without penalty or loss of benefits to which you are 
otherwise 
entitled. 
There will be no cost to you resulting from this study, nor will you receive any 
payment for your participation. However, if any unforeseen expenses arise, you will 
be 
reimbursed. 
By signing this consent form, you do not waive any legal rights, including the right 
to 
seek 
compensation 
for 
injury 
resulting 
from 
your 
participation. 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
If you wish, you may request information about the results of any tests or 
examinations conducted during this study at any time. 
Injuries 
If an injury or any harm occurs as a result of your participation in this research, you 
will receive full medical care without any cost to you for as long as necessary. 
Confidentiality 
The study team will have access to your data; however, your anonymity is 
guaranteed. Any scientific publications resulting from this study will not identify you 
as a participant under any circumstances. All data collected will be handled with 
strict confidentiality. 
Ethics 
This study was approved by the Research Ethics Committee (CEP), a group 
dedicated to protecting research participants and evaluating studies involving 
human 
subjects 
at 
our 
institution. 
For any ethical questions or concerns related to participant rights, please contact 
the Research Ethics Committee of Hospital Albert Einstein by phone at +55 (11) 
2151-3729 or by email at cep@einstein.br. The committee operates Monday 
through Friday, from 7 a.m. to 5 p.m., and is located at Centro de Ensino e 
Pesquisa Albert Einstein – Campus Cecília e Abram Szajman, Rua Comendador 
Elias Jafet, 755, Floor L4, Room 407-G / 407-F - Morumbi, São Paulo / SP - ZIP 
Code 
05653-000. 
For questions related to the study itself, please feel free to contact the study 
coordinators, Eliseth Ribeiro Leão at +55 (11) 2151-1032 (Monday to Friday, 8 
a.m. to 5 p.m.) or Cibele Teixeira Souza at +55 (11) 94299-4012. 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
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Complaints, compliments, and suggestions may be directed to the Customer 
Service System (SAC) by phone at +55 (11) 2151-0222, through the “Contact Us” 
form available on the clinical research webpage, or in person. 
Consent 
Signatures 
I have been informed of all details related to the study in which I will participate. 
I will receive a signed, dated, and initialed copy of this Informed Consent Form, 
and the researcher will keep another signed, dated, and initialed copy. 
 
     
_________________________________________________________________ 
    Full Name of the Research Participant   
 
    
__________________________________________________Date:___/___/___                        
                         Signature of the Research Participant 
   
 
 
      
    
__________________________________________________________________  
Full name and legible signature of the Principal Investigator 
 
 

  
Research Protocol 
 
 
e-Natureza Blue Care - Impact of virtual reality on pain perception, mood and 
analgesic requirements in patients with cancer pain: randomized clinical trial. 
 
 
 
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Initials: 1) Participant ______________________  2) Consent Responsible ______________________ 
 
Version 2_dated April 26, 2025 
   
___________________________________________________Date:___/___/___       
       
 
  Signature of the Principal Investigator