Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study (OUPS)

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 .

Study Overview

• Status: Completed
• Conditions: Palliative Care
• Intervention / Treatment: Other: Clown therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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

Other: Clown therapy; The clowns intervene by twos: a game takes place.; The game requires the active presence of a number of potential players in the room (patient, family, caregivers) and takes into account body position, emotional state, the general atmosphere.; The clowns initiate a game proposal: provisional staging of clown characters based on imagination/improvisation which engages a physicality and a basic emotional state.; The original game proposal is adjusted according to mutual empathy with those present.; The game is developed on the model of theatrical improvisation: an original creation that has "scenic" quality comparable to that of a complete representation. Improvisation time varies depending on the condition of the person, his/her desire to participate, choosing the main theme.; The final stage of the game is preparing all actors for separation: restitution of roles, revisiting the paths traveled.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	1 hour before clown therapy session
ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	1 hour after clown therapy session
ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	Day 2

Secondary Outcome Measures

Outcome Measure	Time Frame
McGill Quality of Life Questionnaire	1 hour before clown therapy session
McGill Quality of Life Questionnaire	Day 2
Semi-directed patient interview	Day 2
Semi-directed caregiver interview	Day 0
Semi-directed staff interview	Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Sylvie Blanchard, MD, Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): November 12, 2016
• Study Completion (Actual): November 12, 2016

Study Registration Dates

• First Submitted: November 17, 2015
• First Submitted That Met QC Criteria: November 18, 2015
• First Posted (Estimate): November 20, 2015

Study Record Updates

• Last Update Posted (Actual): July 28, 2017
• Last Update Submitted That Met QC Criteria: July 27, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: clown therapy
• Other Study ID Numbers: LOCAL/2015/SB-01; 2015-A00719-40 (Other Identifier: RCB number)