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

NCT03518255 | Completed

• 1 other identifier: e-Natureza
• Study Type: interventional
• Target: 164
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cancer

Keywords

Nursing Care; Complementary therapies; Oncological Nursing; Photography

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Edmonton Symptom Assessment Scale (ESAS-Br)

  Change from Baseline Edmonton Symptoms at immediate post intervention, through study completion, an average of 1 year

Other Outcomes (2)

• The Connectedness to Nature Scale

  Single baseline measurement

• Nature Relatedness Questionnaire

  Single baseline measurement

Study Arms (2)

Control group

NO INTERVENTION

This control group will not receive an intervention.

Nature video

EXPERIMENTAL

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

Interventions

Nature video OTHER

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.

Nature video

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Blind patients;
• Patients without the capacity for judgment, in other words, with dementia;
• Patients who have their clinical condition aggravated during the chemotherapy session.

Sponsors & Collaborators

• Hospital Israelita Albert Einstein: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Butantan Institute: collaborator

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

Location

Related Publications (1)

• 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.

  PMID: 28241070 BACKGROUND

MeSH Terms

Conditions

Neoplasms

Study Officials

• Eliseth R Leão, PhD

  Hospital Israelita Albert Einstein- Research Institute

  PRINCIPAL INVESTIGATOR

• 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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: This study has no masking.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: May 8, 2018
• Study Start: August 22, 2018
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: February 9, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)