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

Not Applicable

Completed

• Conditions: Cancer
• Interventions: Other: Nature video

• Registration Number: NCT03518255
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2018-03-12
• Study First Submitted QC: 2018-05-04
• Study First Posted: 2018-05-08
• Study Start: 2018-08-22
• Status Verified: 2021-02
• Primary Completion: 2021-02-08
• Study Completion: 2021-02-08
• Last Update Submitted: 2021-02-08
• Last Update Posted: 2021-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 164

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nature video	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.

Primary Outcome Measures

Name	Time	Method
Positive and Negative Affect Schedule (PANAS)	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

Name	Time	Method
Edmonton Symptom Assessment Scale (ESAS-Br)	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.

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein; 🇧🇷 Sao Paulo, Brazil