Clinical trial NCT02610452: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study
Official title: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Palliative Care
Keywords: clown therapy
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2015-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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 .

Detailed description: 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.

E. Employee satisfaction at the end of the intervention period in the department and after debriefing as assessed by semi-structured interviews conducted by the department psychologist.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: ESAS questionnaire
timeFrame: 1 hour before clown therapy session
measure: ESAS questionnaire
timeFrame: 1 hour after clown therapy session
measure: ESAS questionnaire
timeFrame: Day 2
Secondary outcomes:
measure: McGill Quality of Life Questionnaire
timeFrame: 1 hour before clown therapy session
measure: McGill Quality of Life Questionnaire
timeFrame: Day 2
measure: Semi-directed patient interview
timeFrame: Day 2
measure: Semi-directed caregiver interview
timeFrame: Day 0
measure: Semi-directed staff interview
timeFrame: Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Sylvie Blanchard, MD
role: PRINCIPAL_INVESTIGATOR
References: