Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- ESAS questionnaire
研究概览
简要总结
The main objective of this study was to assess changes in the quality of life of patients in a Palliative Care Unit via the symptoms by the Edmonton Symptom Assessment System (ESAS) before and one hour after the passage of a clown therapist .
详细描述
The secondary objectives of this study are to evaluate before versus after the intervention of clowns therapists:
A. Changes in the quality of life at two days after the intervention (using the ESAS).
B. The quality of life two days after the intervention via the McGill Quality of Life Questionnaire.
C. The quality of life of patients after the intervention as assessed by semi-structured interviews conducted by the department psychologist.
D. The quality of life of caregivers after the intervention as assessed by semi-structured interviews conducted by the department psychologist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient receiving palliative care, ie with a severe and progressive disease bringing into play vital prognosis, in advanced or terminal phase
- •Clinically stable patients, regardless of disease type. The existence of clinical symptoms (pain, discomfort, etc.) found at recruitment by the investigator and not affecting the mental clarity of the subject, does not justify the exclusion of the patient
- •Absence of cognitive disorders; since the protocol provides a clinical interview covering in particular his/her quality of life, included patients will be able to express their feelings
- •In addition, patients who have undergone this type of intervention (clown therapist) will not be excluded from this study.
排除标准
- •The patient is participating in another study
- •The patient is an adult under judicial protection
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •Patient with an inability to fill our protocol assessment scales
- •Patients under treatment known to reduce the level of awareness
- •Patients with major cognitive impairment
- •Patients with symptoms that bring into question their level of awareness
- •Patients with significant risk factors and who should benefit from personalized monitoring from the team (clinically unstable patients, emergency situations, agitated patients, dementia, etc ...).
- •Patient is unable to submit to the continuity of the study.
研究组 & 干预措施
The study population
The study population consists of adult patients treated in the Palliative Care Unit of the University Hospital of Nimes, regardless of their original condition. In 2013 the proportion of stays connected with diagnostics for cancer was 70.16%.
Intervention: Clown therapy
干预措施: Clown therapy (Other)
结局指标
主要结局
ESAS questionnaire
时间窗: Day 2
The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire
ESAS questionnaire
时间窗: 1 hour before clown therapy session
The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire
ESAS questionnaire
时间窗: 1 hour after clown therapy session
The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire
次要结局
- Semi-directed caregiver interview(Day 0)
- McGill Quality of Life Questionnaire(Day 2)
- Semi-directed patient interview(Day 2)
- Semi-directed staff interview(Day 0)
- McGill Quality of Life Questionnaire(1 hour before clown therapy session)