Acute Effect of Chromatic Environment During Chemotherapy Sessions on Health Status and Pain
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- EUROQOL-5D-5L questionnaire: Mobility
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-89 years
- •Diagnosed with breast cancer that required chemotherapy
- •Followed in outpatient clinic
排除标准
- •Diagnosed color blindness
- •Undergoing treatment with antidepressants
研究组 & 干预措施
Cold South
Group B:Cold color scheme, room facing South
干预措施: Room Orientation (Other)
Cold North
Group A: Cold color scheme, room facing North
干预措施: Chromatic Environment (Other)
Cold North
Group A: Cold color scheme, room facing North
干预措施: Room Orientation (Other)
Cold South
Group B:Cold color scheme, room facing South
干预措施: Chromatic Environment (Other)
Warm North
Group C: Warm color scheme, room facing North
干预措施: Chromatic Environment (Other)
Warm North
Group C: Warm color scheme, room facing North
干预措施: Room Orientation (Other)
Warm South
Group D: Warm color scheme, room facing South
干预措施: Chromatic Environment (Other)
Warm South
Group D: Warm color scheme, room facing South
干预措施: Room Orientation (Other)
结局指标
主要结局
EUROQOL-5D-5L questionnaire: Mobility
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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.
EUROQOL-5D-5L questionnaire: EQ-VAS
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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
EUROQOL-5D-5L questionnaire: Pain/Discomfort
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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.
EUROQOL-5D-5L questionnaire: Anxiety/Depression
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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.
EUROQOL-5D-5L questionnaire: Self-care
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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.
EUROQOL-5D-5L questionnaire: Usual activities
时间窗: 5 minutes before to 5 minutes after chemotherapy session
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.
次要结局
- ID-Pain questionnaire(5 minutes before to 5 minutes after chemotherapy session)
- Vital signs: body temperature(5 minutes before to 5 minutes after chemotherapy session)
- Vital signs: blood pressure(5 minutes before to 5 minutes after chemotherapy session)
- Vital signs: heart rate(5 minutes before to 5 minutes after chemotherapy session)
研究者
Margarita Perez
Principal Investigator
Universidad Europea de Madrid