The Visiting Child and His Family in ICU (NCT03954522) | Clinical Trial Compass
CompletedNot Applicable
The Visiting Child and His Family in ICU
France57 participantsStarted 2019-09-26
Plain-language summary
According to literature, it's difficult to evaluate the impact of the visit of the child in ICU. Currently, no recommendations are available regarding welcome and accompany children who visit their relative hospitalized in ICU. Collaboration between humanities and medical sciences brings to this question a complementary look. Majority of studies investigated the question of the impact of young child ICU visit in a unidirectional linear causality scheme visit = psychopathological impact. The visit of the child in ICU should not be considered as an isolated event whose objective characteristics would be alone vectors of trauma. Contrary, the child visit must be apprehended in relation to the quality of the supports on which the child can count. The investigators hypothesize that children can overcome the visit of a kin hospitalized in ICU if accompanying people can support the child and contain, before and after the visit, the emotions of the child.
Who can participate
Age range
6 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:
* family groups in which at least one child aged 6 to 14 years having expressed the wish to visit his/her hospitalized relative
* family groups in which the non-hospitalized parent has expressed the wish to accompany his/her child during the visit
* parent hospitalized in ICU is at least 18 years old
* informed consent of children, non-hospitalized and/or hospitalized relatives
* informed consent of the accompanying caregiver
Exclusion Criteria:
* moribund patient
* child unaccompanied by his/her parent/relative during the visit
* non-hospitalized non-French-speaking parent/relative (need to be able to answer the questionnaires)
* child benefiting from a psychological follow-up prior to the hospitalization of his/her parent
* non French-speaking child
* child under 6 years old or older than 14
* hospitalized relative who died before the proposed interview with the child (particular attention will be carry out to the interview conditions. The loss of the hospitalized parent will not allow for an interview on the experience of the visit).
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
Acute psychotraumatic impact of the visit on the child
Timeframe: 7 days
2
Chronic psychotraumatic impact of the visit on the child
Timeframe: 1 month
3
Psychological experience of the visit for the child
Timeframe: 7 days
4
Parental, family and caregiver support provided to the child during and following the visit
Timeframe: 1 month
5
Psychological experience of the visit according the child age
Timeframe: 1 month
Trial details
NCT IDNCT03954522
SponsorCentre Hospitalier Universitaire de Besancon