- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04046692
School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Firenze, Italy, 50139
- Meyer Chidren's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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children in hospital school in contact with outside school
children experience school's lesson with the hospital teacher in the school's room or into their bedrooms and the investigator give before/after the lesson 2 questionnaire (PANAS-C and PH-C) and the VAS to evaluate the aim's study.
Then, the investigator asks the children to make 2 paintings: one about the hospital school experience (what is for him/her the hospital school) and one about the outside school (what he/she do/did outside during school).
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Operators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.
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children in hospital school NOT in contact with outside school
it's the same of the previous group ("children experiencing hospital school still in contact with outside school"); the only difference of this group is that children are not in contact with the outside school.
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Operators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.
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hospital teachers
teachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule
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operators interview hospital teachers and make them complete a questionnaire (CEESQ)
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outside teachers
teachers have to answer to some questions (qualitative interview) and fill in CEESQ schedule
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operators interview the teachers and make them complete a questionnaire (CEESQ)
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Parents
parents have to answer some questions (qualitative interview)
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Operators interview parents
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Change in Positive and Negative affect before/after hospital school experience
Time Frame: PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.
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PANAS - C (Positive and Negative Affect Scale for Children): original version by Laurent (1999), italian version by Ciucci and collaborators.
30-item numerical scale assessing two dimensions (positive and negative affect, 15-item each) on a 5 point likert scale.
Validated for children between 8 and 12 years old.
Aim of this scale is to evaluate the presence of positive and negative emotions before/after an experience/activity.
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PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation.
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Change in Distress level before/after hospital school experience
Time Frame: PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation.
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PH - C (Psychological Hyperarousal Scale for Children): original version by Laurent (2004), italian version by Ciucci and collaborators.
Numerical scale composed by 18 items measured on a 5 point Likert Scale.
Aim of this scale is to evaluate the presence/absence of distress before and after the activity.
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PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation.
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Change in Pain level before/after hospital school experience
Time Frame: VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation.
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visual analogue scale (VAS) for children, by Scott, Ansell, & Huskisson (1977).
It's a likert scale measuring perceived pain from 0 (no pain) to 10 (maximum pain).
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VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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explorative interview for parents
Time Frame: Investigators interview the parent in a silent and private room within 1 year after child's recruiting
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it's a partially structured interview concerning ideas and opinions of parents about hospital school service
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Investigators interview the parent in a silent and private room within 1 year after child's recruiting
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explorative interview for hospital teachers
Time Frame: investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting
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it's a partially structured interview concerning ideas and opinions of hospital teachers about hospital school service, methods of learning and teaching
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investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting
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explorative interview for outside teachers
Time Frame: investigators arranged an appointment to interview the teacher within 1 year after child's recruiting
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it's a partially structured interview concerning ideas and opinions of outside teachers about hospital school service
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investigators arranged an appointment to interview the teacher within 1 year after child's recruiting
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research form for investigator
Time Frame: within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form
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it's a research partially structured form regarding informations about how it's organised hospital school service
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within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form
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research form for the outside teacher
Time Frame: through study completion, an average of 1 year, the outside teacher fill in the form after a lesson
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it's a research partially structured form regarding informations about how it's organised hospital school service
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through study completion, an average of 1 year, the outside teacher fill in the form after a lesson
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child's emotions and ideas about hospital school service
Time Frame: 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
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investigators ask the child to draw the hospital school service and then is asked what he/she has drawn, what it represents, what's for him/her the best moment of hospital school
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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
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child's emotions and ideas about outside school service
Time Frame: 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
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investigators ask the child to draw the outside school service and then is asked what he has drawn, what it represents, what's for him/her the best moment of school; also, children is asked if he/she perceives a difference between outside school and hospital school service
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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
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emotions and self efficacy of hospital teachers
Time Frame: the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting
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CEESQ (Crèche Educators Emotional Style Questionnaire): italian version by Ciucci, Baroncelli and Toselli (2015); numerical scale measuring emotions and self efficacy on a likert scale from 0 to 5; it takes around 10/15 minutes
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the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Rosanna Martin, MSc, Meyer Children's Hospital IRCCS
Publications and helpful links
General Publications
- Antonelli E, Vagnoli L, Ciucci E, Vernucci C, Lachi F, Messeri A. A Comparison of Nonpharmacologic Interventions on the Emotional State of Children in the Emergency Department. Pediatr Emerg Care. 2019 Feb;35(2):81-88. doi: 10.1097/PEC.0000000000000900.
- Charlton A, Larcombe IJ, Meller ST, Morris Jones PH, Mott MG, Potton MW, Tranmer MD, Walker JJ. Absence from school related to cancer and other chronic conditions. Arch Dis Child. 1991 Oct;66(10):1217-22. doi: 10.1136/adc.66.10.1217.
- Clatworthy S, Simon K, Tiedeman ME. Child drawing: hospital--an instrument designed to measure the emotional status of hospitalized school-aged children. J Pediatr Nurs. 1999 Feb;14(1):2-9. doi: 10.1016/S0882-5963(99)80054-2.
- Clatworthy S, Simon K, Tiedeman M. Child drawing: hospital manual. J Pediatr Nurs. 1999 Feb;14(1):10-8. doi: 10.1016/S0882-5963(99)80055-4. No abstract available.
- Georgiadi, M., & Kourkoutas, E. E. (2010). Supporting pupils with cancer on their return to school: a case study report of a reintegration program. Procedia-Social and Behavioral Sciences, 5, 1288-1282.
- Hughes AA, Kendall PC. Psychometric properties of the Positive and Negative Affect Scale for Children (PANAS-C) in children with anxiety disorders. Child Psychiatry Hum Dev. 2009 Sep;40(3):343-52. doi: 10.1007/s10578-009-0130-4. Epub 2009 Jan 14.
- Katz LF, Leary A, Breiger D, Friedman D. Pediatric cancer and the quality of children's dyadic peer interactions. J Pediatr Psychol. 2011 Mar;36(2):237-47. doi: 10.1093/jpepsy/jsq050. Epub 2010 Jun 2.
- Laurent J, Catanzaro SJ, Joiner TE Jr. Development and preliminary validation of the physiological hyperarousal scale for children. Psychol Assess. 2004 Dec;16(4):373-80. doi: 10.1037/1040-3590.16.4.373.
- Pelander T, Lehtonen K, Leino-Kilpi H. Children in the hospital: elements of quality in drawings. J Pediatr Nurs. 2007 Aug;22(4):333-41. doi: 10.1016/j.pedn.2007.06.004.
- af Sandeberg M, Johansson E, Bjork O, Wettergren L. Health-related quality of life relates to school attendance in children on treatment for cancer. J Pediatr Oncol Nurs. 2008 Sep-Oct;25(5):265-74. doi: 10.1177/1043454208321119. Epub 2008 Jul 22.
- Worchel-Prevatt, F. F., Heffer, R. W., Prevatt, B. C., Miner, J., Young-Saleme, T., Horgan, D., ... & Frankel, L. (1998). A school reentry program for chronically ill children. Journal of school psychology, 36(3), 261-289.
- Yilmaz MC, Sari HY, Cetingul N, Kantar M, Erermis S, Aksoylar S. Determination of school-related problems in children treated for cancer. J Sch Nurs. 2014 Oct;30(5):376-84. doi: 10.1177/1059840513506942. Epub 2013 Sep 27.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Hospital_School
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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