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Completed

NCT Number: NCT02610452

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

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 .

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Key information

Conditions

Palliative Care

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clown therapy

Other

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.

Primary outcomes

  1. ESAS questionnaire

    Time frame: 1 hour before clown therapy session

    The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire

  2. ESAS questionnaire

    Time frame: 1 hour after clown therapy session

    The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire

  3. ESAS questionnaire

    Time frame: Day 2

    The ESAS (Edmonton Symptom Assessment System) self-administered questionnaire

Secondary outcomes

  1. McGill Quality of Life Questionnaire

    Time frame: 1 hour before clown therapy session

  2. McGill Quality of Life Questionnaire

    Time frame: Day 2

  3. Semi-directed patient interview

    Time frame: Day 2

  4. Semi-directed caregiver interview

    Time frame: Day 0

  5. Semi-directed staff interview

    Time frame: Day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: OUPS

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Jul 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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