Clinical trial NCT03518255: e-Natureza Project - Affective Validation of Nature Images for Hospital Use
Official title: e-Natureza: Affective Validation of Nature Images as a Complementary Resource for Promoting Well-being in Hospital Environment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Keywords: Nursing Care
Complementary therapies
Oncological Nursing
Photography
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Butantan Institute
First posted: 2018-05-08
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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

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.

Eligibility 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.

Primary outcomes:
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Change from Baseline positive and negative affects at immediate post intervention, through study completion, an average of 1 year
Secondary outcomes:
measure: Edmonton Symptom Assessment Scale (ESAS-Br)
timeFrame: Change from Baseline Edmonton Symptoms at immediate post intervention, through study completion, an average of 1 year
Other outcomes:
measure: The Connectedness to Nature Scale
timeFrame: Single baseline measurement
measure: Nature Relatedness Questionnaire
timeFrame: Single baseline measurement
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Hospital Israelita Albert Einstein- Research Institute
name: Eliseth R Leão, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal Technological University of Paraná
name: Gustavo B Borba, PhD
role: STUDY_CHAIR
affiliation: National Geografic
name: João M Rosa, BAA
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein- Research Institute
name: Elivane S Victor, BSS
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein- Research Institute
name: Daniela R Dal Fabbro, BSN
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein- Research Institute
name: Giulia C Lima, BSN
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein- Research Institute
name: Tinely B Souza, Student
role: STUDY_CHAIR
affiliation: Hospital Israelita Albert Einstein- Oncological Unit
name: Fábio S Romano, BSc
role: STUDY_CHAIR
affiliation: Butanta Institute
name: Erika H Zaher, PhD
role: STUDY_CHAIR
affiliation: Butanta Institute
name: Luciano M Lima, MSc
role: STUDY_CHAIR
References:
citation: Leao ER, Dal Fabbro DR, Oliveira RB, Santos IR, Victor ED, Aquarone RL, Andrade CB, Ribeiro VF, Oliveira RC, Friedlander R, Ferreira DS. Stress, self-esteem and well-being among female health professionals: A randomized clinical trial on the impact of a self-care intervention mediated by the senses. PLoS One. 2017 Feb 27;12(2):e0172455. doi: 10.1371/journal.pone.0172455. eCollection 2017.