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| Name | Class |
|---|---|
| Instituto Oncológico Balselga | UNKNOWN |
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The primary objective is to examine the acute effect of color, room orientation (affecting amount of luminosity) on perceived health status and stress levels in oncologic patients during chemotherapy sessions at outpatient clinic. The secondary objectives will be to study the effect on vital signs (body temperature, heart rate, systolic blood pressure). Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South) for each session. For the next session, patients will be assigned a new condition. Assignment of sequences will be randomized for each patient.
20 patients will be randomly assigned to one of the four groups, after having signed the Free and Informed Consent Form and agreed to participate in the project, will respond to the evaluation form and will be submitted to physical examination. Patients will be treated per standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cold North | Experimental | Group A: Cold color scheme, room facing North |
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| Cold South | Experimental | Group B:Cold color scheme, room facing South |
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| Warm North | Experimental | Group C: Warm color scheme, room facing North |
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| Warm South | Experimental | Group D: Warm color scheme, room facing South |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chromatic Environment | Other | Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment. |
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| Measure | Description | Time Frame |
|---|---|---|
| EUROQOL-5D-5L questionnaire: Mobility | The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension. | 5 minutes before to 5 minutes after chemotherapy session |
| EUROQOL-5D-5L questionnaire: Self-care | The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension. | 5 minutes before to 5 minutes after chemotherapy session |
| EUROQOL-5D-5L questionnaire: Usual activities | The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension. | 5 minutes before to 5 minutes after chemotherapy session |
| EUROQOL-5D-5L questionnaire: Pain/Discomfort | The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension. | 5 minutes before to 5 minutes after chemotherapy session |
| EUROQOL-5D-5L questionnaire: Anxiety/Depression | The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement using a 1-digit number that expresses the level selected for that dimension. | 5 minutes before to 5 minutes after chemotherapy session |
| EUROQOL-5D-5L questionnaire: EQ-VAS |
| Measure | Description | Time Frame |
|---|---|---|
| ID-Pain questionnaire | Assessment of neuropathic pain | 5 minutes before to 5 minutes after chemotherapy session |
| Vital signs: body temperature | Per standard of care, in Celsius |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Paula Gomez Vela, BS | Contact | +34620820447 | paulagvela@velasalvadorarquitectos.com | |
| Margarita Pérez Ruiz, MD,PhD | Contact | +34649084705 | margarita.perez@universidadeuropea.es |
| Name | Affiliation | Role |
|---|---|---|
| Margarita Pérez Ruiz, MD, PhD | Universidad Europea | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Ruber Internacional | Recruiting | Madrid | 28034 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31482404 | Derived | Gomez-Vela P, Perez-Ruiz M, Hernandez Martin MF, Roman J, Larumbe-Zabala E. Acute effect of orange chromatic environment on perceived health status, pain, and vital signs during chemotherapy treatment. Support Care Cancer. 2020 May;28(5):2321-2329. doi: 10.1007/s00520-019-05064-w. Epub 2019 Sep 3. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Patients will be allocated into four conditions (Group A: Cold North, Group B: Cold South C: Warm North D: Warm South), and they will be assigned a new condition at each next visit. The sequence will be assigned randomly to each patient. During each of the four visits, the patients will be treated per standard of care during their chemotherapy sessions. Outcome variables will be assessed before and after each visit.
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| Room Orientation | Other | Room will be facing North or South |
|
The EQ VAS is an independent subscale of the EUROQOL-5D-5L questionnaire, which uses a vertical visual analogue scale format. The EQ VAS is used for recording the self-rated health on a range from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (100) and 'The worst health you can imagine' (0). The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement
| 5 minutes before to 5 minutes after chemotherapy session |
| 5 minutes before to 5 minutes after chemotherapy session |
| Vital signs: blood pressure | Per standard of care, in mm Hg | 5 minutes before to 5 minutes after chemotherapy session |
| Vital signs: heart rate | Per standard of care, in beats per minute | 5 minutes before to 5 minutes after chemotherapy session |
| D017437 |
| Skin and Connective Tissue Diseases |