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Acute Effect of Chromatic Environment During Chemotherapy

NCT03873519 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-03-31

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Chromatic Environment

Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.

OTHER

Room Orientation

Room will be facing North or South

Sponsors & Collaborators

  • Instituto Oncológico Balselga

    collaborator UNKNOWN

  • Universidad Europea de Madrid

    lead OTHER

Principal Investigators

  • Margarita Pérez Ruiz, MD, PhD · Universidad Europea

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-15
Primary Completion
2020-12-15
Completion
2020-12-15

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03873519 on ClinicalTrials.gov