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

Palliative Care Clinical Trial

— OUPS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02610452
• Other study ID #: LOCAL/2015/SB-01
• Secondary ID: 2015-A00719-40
• Status: Completed
• Phase: N/A
• First received: November 17, 2015
• Last updated: July 27, 2017
• Start date: March 31, 2016
• Est. completion date: November 12, 2016

Study information

• Verified date: July 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 12, 2016
• Est. primary completion date: November 12, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Palliative Care

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	1 hour before clown therapy session
Primary	ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	1 hour after clown therapy session
Primary	ESAS questionnaire	The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire	Day 2
Secondary	McGill Quality of Life Questionnaire		1 hour before clown therapy session
Secondary	McGill Quality of Life Questionnaire		Day 2
Secondary	Semi-directed patient interview		Day 2
Secondary	Semi-directed caregiver interview		Day 0
Secondary	Semi-directed staff interview		Day 0