School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencin… (NCT04046692) | Clinical Trial Compass
CompletedNot Applicable
School Activity for the Reduction of Distress, Pain and Negative Emotions in Children Experiencing Hospital School
Italy180 participantsStarted 2017-03-15
Plain-language 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.
Who can participate
Age range
8 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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.
2
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.
3
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.