Clinical trial NCT04046692: School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School
Official title: Cross - Observational Study About Hospital School Experience for the Reduction of Distress, Pain and Negative Experience and for the Promotion of School Experience's Continuity. the Point of View of Teachers, Children and Parents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hospital School Experience
Keywords: hospital school
pain
distress
negative emotions
school continuity
child
Lead sponsor: Meyer Children's Hospital IRCCS
Sponsor class: OTHER
Collaborators: name: University of Florence
First posted: 2019-08-06
Enrollment: 180
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children 8-12 years old in oncology and pediatric wards, having hospital school into Meyer Hospital; parents of these children; hospital and not hospital teachers of the patients included in the study

Brief summary: Aim of present study is to evaluate the efficacy of hospital school experience in the reduction of distress, pain and negative emotion in children from 8 to 12 years old, hospitalized in oncology and pediatric wards. Investigators also want to explore the ideas and opinions of teachers and parents about hospital school service.

Hypothesis: the investigators expect a reduction in pain, distress and negative emotions.

Detailed description: The school service into the hospital was born as an attempt to support emotionally, relationally and cognitively the hospitalized children, who have to spend a lot of time alone, without being educated by teachers with their classmates. There are not many studies in the Italian contest about this issue and with the present study the investigators intended to implement the acknowledgement about this theme.

The principal aim of this study is to explore if the school service reduces negative emotions experienced by oncological children as well as perceived pain and distress. To evaluate this aims, the investigators organized the study in 3 sections: the first is about the emotions experienced by oncological children between 8 and 12 years old, who benefit from the school service into the hospital; the second is about their parents' opinions and believes about the hospital school service; the third is about opinions, training and educational method dedicated by hospital school teachers and not hospital school teachers (who previously thought to our oncology children sample).

Eligibility criteria: Inclusion Criteria for children:

* age between 8 and 12 years old
* knowledge of Italian language
* consent for study participation
* recovery
* be/not be in contact with classmates (group A and group B)

Exclusion Criteria for Children:

* patients who have already had hospital school experience in the past
* cognitive disability
* patients that cannot complete the study because of health or mental issues incoming during the period of the research

Inclusion criteria for hospital teachers:

* Italian knowledge
* Being a hospital teacher

Exclusion criteria for hospital teachers:

- Have earlier experience as a hospital children in other hospitals

Inclusion criteria for not hospital teachers:

* Italian knowledge
* Being a teacher of the hospitalized children in the past or present time exclusion criteria for not hospital teachers:
* A past experience as a hospital teacher

Inclusion criteria for parents:

* Italian knowledge
* consent for study participation
* Health or mental issues that can cause problems in completing questionnaires or answering questions

Exclusion criteria for parents:

* Cognitive disability
* Health or mental issues that can cause problems in completing questionnaires or answering questions

Primary outcomes:
measure: Change in Positive and Negative affect before/after hospital school experience
timeFrame: PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.
measure: Change in Distress level before/after hospital school experience
timeFrame: PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation.
measure: Change in Pain level before/after hospital school experience
timeFrame: VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation.
Secondary outcomes:
measure: explorative interview for parents
timeFrame: Investigators interview the parent in a silent and private room within 1 year after child's recruiting
measure: explorative interview for hospital teachers
timeFrame: investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting
measure: explorative interview for outside teachers
timeFrame: investigators arranged an appointment to interview the teacher within 1 year after child's recruiting
measure: research form for investigator
timeFrame: within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form
measure: research form for the outside teacher
timeFrame: through study completion, an average of 1 year, the outside teacher fill in the form after a lesson
measure: child's emotions and ideas about hospital school service
timeFrame: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
measure: child's emotions and ideas about outside school service
timeFrame: within 1 year after child's recruiting, investigators ask the child to draw when present in the Oncology Day Hospital or in the oncology/pediatric ward and then pick the draw
measure: emotions and self efficacy of hospital teachers
timeFrame: the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting
Other outcomes:
Locations:
city: Firenze
country: Italy
facility: Meyer Chidren's Hospital
Study officials:
affiliation: Meyer Children's Hospital IRCCS
name: Rosanna Martin, MSc
role: STUDY_DIRECTOR
References:
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