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Completed

NCT Number: NCT03518255

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

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Collaborators

  • Butantan Institute
  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: E-natureza

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 8, 2018
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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