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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02610452
Date of registration: 17/11/2015
Prospective Registration: Yes
Primary sponsor: Centre Hospitalier Universitaire de Nimes
Public title: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study OUPS
Scientific title: Assessing the Impact of Clown Therapy in a Palliative Care Unit: A Prospective, Descriptive Study
Date of first enrolment: March 31, 2016
Target sample size: 30
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02610452
Study type:  Interventional
Study design:  Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
France
Contacts
Name:     Sylvie Blanchard, MD
Address: 
Telephone:
Email:
Affiliation:  Centre Hospitalier Universitaire de NĂ®mes
Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Palliative Care
Intervention(s)
Other: Clown therapy
Primary Outcome(s)
ESAS questionnaire [Time Frame: 1 hour after clown therapy session]
ESAS questionnaire [Time Frame: 1 hour before clown therapy session]
ESAS questionnaire [Time Frame: Day 2]
Secondary Outcome(s)
McGill Quality of Life Questionnaire [Time Frame: Day 2]
Semi-directed patient interview [Time Frame: Day 2]
McGill Quality of Life Questionnaire [Time Frame: 1 hour before clown therapy session]
Semi-directed caregiver interview [Time Frame: Day 0]
Semi-directed staff interview [Time Frame: Day 0]
Secondary ID(s)
LOCAL/2015/SB-01
2015-A00719-40
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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