Hospital School Experience Clinical Trial
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
| Verified date | February 2021 |
| Source | Meyer Children's Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 180 |
| Est. completion date | March 15, 2020 |
| Est. primary completion date | January 15, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 8 Years to 12 Years |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Meyer Chidren's Hospital | Firenze |
| Lead Sponsor | Collaborator |
|---|---|
| Meyer Children's Hospital | University of Florence |
Italy,
af Sandeberg M, Johansson E, Björk 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. — View Citation
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. — View Citation
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. — View Citation
Clatworthy S, Simon K, Tiedeman M. Child drawing: hospital manual. J Pediatr Nurs. 1999 Feb;14(1):10-8. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
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. — View Citation
* Note: There are 12 references in all — Click here to view all references
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in Positive and Negative affect before/after hospital school experience | 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. | PANAS - C is completed by the child before and after the school experience (average 3 months); it takes around 5 minutes for each investigation. | |
| Primary | Change in Distress level before/after hospital school experience | 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. | PH - C is completed by the child before and after the school experience (average 3 months); it takes around 3 minutes for each investigation. | |
| Primary | Change in Pain level before/after hospital school experience | 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). | VAS is completed by the child before and after the school experience (average 3 months); it takes around 30 seconds for each investigation. | |
| Secondary | explorative interview for parents | it's a partially structured interview concerning ideas and opinions of parents about hospital school service | Investigators interview the parent in a silent and private room within 1 year after child's recruiting | |
| Secondary | explorative interview for hospital teachers | it's a partially structured interview concerning ideas and opinions of hospital teachers about hospital school service, methods of learning and teaching | investigators interview the hospital teacher in a silent and private room within 3 months after child's recruiting | |
| Secondary | explorative interview for outside teachers | it's a partially structured interview concerning ideas and opinions of outside teachers about hospital school service | investigators arranged an appointment to interview the teacher within 1 year after child's recruiting | |
| Secondary | research form for investigator | it's a research partially structured form regarding informations about how it's organised hospital school service | within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form | |
| Secondary | research form for the outside teacher | it's a research partially structured form regarding informations about how it's organised hospital school service | through study completion, an average of 1 year, the outside teacher fill in the form after a lesson | |
| Secondary | child's emotions and ideas about hospital school service | 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 | 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 | |
| Secondary | child's emotions and ideas about outside school service | 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 | 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 | |
| Secondary | emotions and self efficacy of hospital teachers | 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 | the investigator asks the teacher to fill in the questionnaire, within 3 months after child's recruiting |