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

NCT02610452 | Completed

• 2 other identifiers: LOCAL/2015/SB-012015-A00719-40
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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 .

Conditions

Palliative Care

Keywords

clown therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• 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

Study Arms (1)

The study population

EXPERIMENTAL

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

Interventions

Clown therapy OTHER

The clowns intervene by twos: a game takes place. 1. 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. 2. The clowns initiate a game proposal: provisional staging of clown characters based on imagination/improvisation which engages a physicality and a basic emotional state. 3. The original game proposal is adjusted according to mutual empathy with those present. 4. 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. 5. The final stage of the game is preparing all actors for separation: restitution of roles, revisiting the paths traveled.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Interventions

Laughter Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics

Study Officials

• Sylvie Blanchard, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2015
• First Posted: November 20, 2015
• Study Start: March 31, 2016
• Primary Completion: November 12, 2016
• Study Completion: November 12, 2016
• Last Updated: July 28, 2017

Record last verified: 2017-07

Locations

FR (1)