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NCT Number: NCT04046692

School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School

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.

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Key information

Conditions

Hospital School Experience Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

8 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Meyer Chidren's Hospital

Florence, Firenze, 50139, Italy

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hospital School Experience, point of view of the children

Other

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.

Hospital School Experience, point of view of the hospital teachers

Other

operators interview hospital teachers and make them complete a questionnaire (CEESQ)

Hospital School Experience, point of view of the non hospital teachers

Other

operators interview the teachers and make them complete a questionnaire (CEESQ)

Hospital School Experience, point of view of parents

Other

Operators interview parents

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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).

Secondary outcomes

  1. explorative interview for parents

    Time frame: Investigators interview the parent in a silent and private room within 1 year after child's recruiting

    it's a partially structured interview concerning ideas and opinions of parents about hospital school service

  2. 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

    it's a partially structured interview concerning ideas and opinions of hospital teachers about hospital school service, methods of learning and teaching

  3. explorative interview for outside teachers

    Time frame: investigators arranged an appointment to interview the teacher within 1 year after child's recruiting

    it's a partially structured interview concerning ideas and opinions of outside teachers about hospital school service

  4. research form for investigator

    Time frame: within 3 months after child's recruiting, the researcher observes a lesson and then fills in the form

    it's a research partially structured form regarding informations about how it's organised hospital school service

  5. 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

    it's a research partially structured form regarding informations about how it's organised hospital school service

  6. 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

    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

  7. 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

    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

  8. 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

    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

Sponsors and collaborators

Lead sponsor

Meyer Children's Hospital IRCCS

Other

Collaborators

  • University of Florence

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Aug 6, 2019
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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