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Trial record 47 of 221 for:    Recruiting, Not yet recruiting, Available Studies | "informed consent"

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

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ClinicalTrials.gov Identifier: NCT03518255
Recruitment Status : Not yet recruiting
First Posted : May 8, 2018
Last Update Posted : August 8, 2018
Sponsor:
Collaborators:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Butantan Institute
Information provided by (Responsible Party):
Hospital Israelita Albert Einstein

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

Condition or disease Intervention/treatment Phase
Cancer Other: Nature video Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
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
Estimated Study Start Date : August 30, 2018
Estimated Primary Completion Date : March 30, 2019
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Eliseth R Leão, PhD +55 (11) 99618-6489 eliseth.leao@einstein.br
Contact: Daniela R Dal Fabbro, BSN +55 (11) 97672- 4040 Daniela.Fabbro@einstein.br

Sponsors and Collaborators
Hospital Israelita Albert Einstein
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, Student 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
  Study Documents (Full-Text)

Documents provided by Hospital Israelita Albert Einstein:
Informed Consent Form  [PDF] January 31, 2017


Publications:
Responsible Party: Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier: NCT03518255     History of Changes
Other Study ID Numbers: e-Natureza
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: August 8, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hospital Israelita Albert Einstein:
Nursing Care
Complementary therapies
Oncological Nursing
Photography