e-Natureza Project - Affective Validation of Nature Images for Hospital Use (E-natureza)

February 8, 2021 updated by: Hospital Israelita Albert Einstein

e-Natureza: Affective Validation of Nature Images as a Complementary Resource for Promoting Well-being in Hospital Environment

Randomized clinical trial about the evaluation of the use of nature photographs in the positive and negative affects of oncological patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In recent decades there has been growing interest from researchers in understanding how the adoption of natural elements in daily life, even in hospitals, can characterize restorative environments and reflect in better health for patients. Contact with nature can be done indirectly through photographs. This clinical trial aims to verify the therapeutic potential of the nature images, previously validated in another part of this study, in the care of cancer patients undergoing chemotherapy. Anchored on the assumptions of the theory of Biophilia, and the environmental theory of Florence Nightingale our study hypothesis is that this intervention promotes well-being and promote more positive mood states, and reduce symptoms resulting from the treatment during chemotherapy session.

Study Type

Interventional

Enrollment (Actual)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05652-900
        • Hospital Israelita Albert Einstein

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Voluntary participation;
  • Signed in the Informed Consent Form;
  • Who are undergoing chemotherapy treatment;
  • Patients need to be on the first chemotherapy session, independently of oncological disease;
  • Patients with clinical conditions and preserved communication function, in other words, lucid patients.

Exclusion Criteria:

  • Blind patients;
  • Patients without the capacity for judgment, in other words, with dementia;
  • Patients who have their clinical condition aggravated during the chemotherapy session.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
This control group will not receive an intervention.
Experimental: Nature video
A pre-validated nature images video will be shown to the patient during their chemotherapy session. After thirty minutes of the start of the chemotherapy session, the patient you will receive a notebook (specific to the study and blocked for other functions) that he can watch a presentation of nature images. It will be four videos with fifteen minutes each one.
Other: Nature video
After signing the Informed Consent Form, the participants will respond to a demographic questionnaire to characterize the sample and then they will watch nature videos. After that, will be applied a scale questionnaire about the physical and psychological symptoms of chemotherapy in the positive and negative mood of that patient.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive and Negative Affect Schedule (PANAS)
Time Frame: Change from Baseline positive and negative affects at immediate post intervention, through study completion, an average of 1 year
The questionnaire aims to verify the positive and negative affects of participants in oncologic treatment before and after their first chemotherapy session, in order to verify if after the intervention, the negative affects decrease and the positive ones increase. Each questionnaire will be analyzed individually.
Change from Baseline positive and negative affects at immediate post intervention, through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Edmonton Symptom Assessment Scale (ESAS-Br)
Time Frame: Change from Baseline Edmonton Symptoms at immediate post intervention, through study completion, an average of 1 year
This tool is designed to assist in the assessment of nine symptoms common in cancer patients: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing and shortness of breath, (there is also a line labelled "Other Problem"). The severity at the time of assessment of each symptom is rated from 0 to 10 on a numerical scale, 0 meaning that the symptom is absent and 10 that it is of the worst possible severity. It does not have final classification scores. It measures the frequency and intensity of symptoms presented at the time of its application.
Change from Baseline Edmonton Symptoms at immediate post intervention, through study completion, an average of 1 year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Connectedness to Nature Scale
Time Frame: Single baseline measurement
The Nature Connection Scale is used to verify the affective aspect of the person-environment relationship. It is composed of 14 items, which are answered in a scale of 5 points, ranging from 1 (I totally disagree) to 5 (I totally agree). The higher the score, the greater the individual's connection with nature.
Single baseline measurement
Nature Relatedness Questionnaire
Time Frame: Single baseline measurement
The 21-item Nature Relatedness Scale (NR) assesses subjective connectedness with the natural environment. Participants respond to statements using a 5-point Likert scale (1 = strongly disagree, 5 = strongly agree) and items are averaged with higher scores indicating stronger connectedness.
Single baseline measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Israelita Albert Einstein

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico
Butantan Institute

Investigators

  • Principal Investigator: Eliseth R Leão, PhD, Hospital Israelita Albert Einstein- Research Institute
  • Study Chair: Gustavo B Borba, PhD, Federal Technological University of Paraná
  • Study Chair: João M Rosa, BAA, National Geografic
  • Study Chair: Elivane S Victor, BSS, Hospital Israelita Albert Einstein- Research Institute
  • Study Chair: Daniela R Dal Fabbro, BSN, Hospital Israelita Albert Einstein- Research Institute
  • Study Chair: Giulia C Lima, BSN, Hospital Israelita Albert Einstein- Research Institute
  • Study Chair: Tinely B Souza, Student, Hospital Israelita Albert Einstein- Research Institute
  • Study Chair: Fábio S Romano, BSc, Hospital Israelita Albert Einstein- Oncological Unit
  • Study Chair: Erika H Zaher, PhD, Butanta Institute
  • Study Chair: Luciano M Lima, MSc, Butanta Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 22, 2018

Primary Completion (Actual)

February 8, 2021

Study Completion (Actual)

February 8, 2021

Study Registration Dates

First Submitted

March 12, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

February 9, 2021

Last Update Submitted That Met QC Criteria

February 8, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • e-Natureza

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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