Acute Effect of Chromatic Environment During Chemotherapy

European University

Status: Unknown

Conditions: Breast Cancer

Treatments: Other: Room Orientation; Other: Chromatic Environment

Study type: Interventional

Funder types: Other

Identifiers

NCT03873519

R-2017/UEM11

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18-89 years
• Diagnosed with breast cancer that required chemotherapy
• Followed in outpatient clinic

Exclusion criteria

• Diagnosed color blindness
• Undergoing treatment with antidepressants

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 4 patient groups

Cold North

Experimental group

Description:

Group A: Cold color scheme, room facing North

Treatment:

Other: Room Orientation

Other: Chromatic Environment

Cold South

Experimental group

Description:

Group B:Cold color scheme, room facing South

Treatment:

Other: Room Orientation

Other: Chromatic Environment

Warm North

Experimental group

Description:

Group C: Warm color scheme, room facing North

Treatment:

Other: Room Orientation

Other: Chromatic Environment

Warm South

Experimental group

Description:

Group D: Warm color scheme, room facing South

Treatment:

Other: Room Orientation

Other: Chromatic Environment