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The diagnosis and treatment of childhood cancer involves frequent and repeated painful acts. The pediatric oncology-hematology service of Nancy's hospital innovates thanks to the involvement of clowns in the hospital. The effects of the clown's intervention corroborate the results of studies which demonstrate that when painful complaints are increased by an empathetic attitude, they are reduced by half when the child is distracted.
The main objective is to assess the impact of the presence or absence of clowns during the performance of a painful act, on pain, in children who have benefited from this act. no clowns during the performance of a painful act, on anxiety, in children who have benefited from this act.
The secondary objectives are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Without Clowns - Clowns (WC-C) | Other | Firstly a painful act without the presence of the clown duo, then in a second time the same painful act in the presence of the clown duo |
|
| Clowns- Without clowns (C-WC) | Other | Firstly a painful act with the presence of the clown duo, then in a seconde time, the same painful act without the presence of the clown duo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| clowns | Other | presence or absence of clowns during the performance of a painful act, on pain |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of Pain score of the patient Self Assessment Scale (VAS) | The scale is between 0 to 100 | inclusion, up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS) | The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious | inclusion, up to 2 years |
| Anxiety score of the patient with modified-Yale Preoperative Anxiety Scale (m-YPAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Valérie GAUZES | Contact | 0383154066 | v.gauzes@chru-nancy.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascal Chastagner | CHRU de Nancy | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nancy | Recruiting | Nancy | 54035 | France |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The scale is between 0 to 100 If the score is inferior to 24, the patient is considered relaxed If the score is superior to 24, the patient is considered anxious |
| up to 8 weeks after inclusion |
| Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B) | The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | inclusion, up to 2 years |
| Usual Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-B) | The score is between 21 to 77 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | up to 8 weeks after inclusion |
| Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A) | The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | inclusion, up to 2 years |
| Change of Anxiety score of the parents Questionnaire State-Trait Anxiety Inventory (STAI form Y-A) | The score is between 20 to 80 Score superior to 65 : very high anxiety Score between 56 to 65 : high anxiety Score between 46 to 55 : medium anxiety Score between 36 to 45 : low anxiety Score inferior to 35 : very low anxiety | up to 8 weeks after inclusion |
| Score of perception and acceptance of the presence of clowns with the healthcare team Questionnaire | The questionnaire is composed by 19 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree) | through completion of the study, an average of 2 years |
| Perception score of interactions with the child, parents and the team with clowns Questionnaire | The questionnaire is composed by 12 questions The scale of each question is between 1 (not agree at all) to 4 (totally agree) | through completion of the study, an average of 2 years |
| Score of evaluation of the overall impact of the presence or not of a clown Questionnaire | The observation gris is composed by 14 questions | through completion of the study, an average of 2 years |