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| Name | Class |
|---|---|
| Conselho Nacional de Desenvolvimento CientÃfico e Tecnológico | OTHER_GOV |
| Butantan Institute | OTHER_GOV |
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Randomized clinical trial about the evaluation of the use of nature photographs in the positive and negative affects of oncological patients.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Israelita Albert Einstein | São Paulo | 05652-900 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28241070 | Background | 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. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jan 31, 2017 | Apr 3, 2018 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 31, 2017 | Apr 16, 2018 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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This study has no masking.
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| Change from Baseline Edmonton Symptoms at immediate post intervention, through study completion, an average of 1 year |
| 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 |
| Luciano M Lima, MSc | Butanta Institute | Study Chair |