e-Natureza Project - Affective Validation of Nature Images for Hospital Use (E-natureza)
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|ClinicalTrials.gov Identifier: NCT03518255|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : December 21, 2018
|Condition or disease||Intervention/treatment||Phase|
|Cancer||Other: Nature video||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Masking Description:||This study has no masking.|
|Primary Purpose:||Supportive Care|
|Official Title:||e-Natureza: Affective Validation of Nature Images as a Complementary Resource for Promoting Well-being in Hospital Environment|
|Actual Study Start Date :||August 22, 2018|
|Estimated Primary Completion Date :||March 30, 2019|
|Estimated Study Completion Date :||January 31, 2020|
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.
- 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.
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518255
|Contact: Eliseth R Leão, PhD||+55 (11) firstname.lastname@example.org|
|Contact: Daniela R Dal Fabbro, BSN||+55 (11) 97672- 4040||Daniela.Fabbro@einstein.br|
|Hospital Israelita Albert Einstein||Recruiting|
|Sao Paulo, Brazil, 05652-900|
|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|