e-Natureza Project - Affective Validation of Nature Images for Hospital Use

Cancer Clinical Trial

— E-natureza  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03518255
• Other study ID #: e-Natureza
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: February 8, 2021

Study information

• Verified date: February 2021
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 164
• Est. completion date: February 8, 2021
• Est. primary completion date: February 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo

Sponsors (3)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein	Butantan Institute, Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

Leão 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Connectedness to Nature Scale	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
Other	Nature Relatedness Questionnaire	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
Primary	Positive and Negative Affect Schedule (PANAS)	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	Edmonton Symptom Assessment Scale (ESAS-Br)	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