Intensive CareENVIFARNCT03954522
The Visiting Child and His Family in ICU
A study testing interview in people with Intensive Care and Child, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intensive Care, Child, Acute Stress Disorder
- What is being tested?
- interview
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2019to 23 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU
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.
- Being tested
- interview
- Keywords
- ICU, acute stress, PTSD, child, parent hospitalized
- Medical subject headings
- Stress Disorders, Traumatic, Acute, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
interviewOther
Child = A clinical interview (recorded, duration approximately 30 min) and a scale of acute stress (IES child) will be performed at 2 times (during the 7 days following the first visit of hospitalized kin and 1 month after the kin was discharged from ICU)
Accompanying parent/kin = Semi-directive interviews (recorded - duration approximately 30 min) will be performed at the same time as those of the child and will be recorded. The parent/kin will also complete a socio-demographic questionnaire of the family group and a depression anxiety scale (HADS)
Nursing staff = A semi-directive interview (recorded - duration approximately 30 min) will be performed only once (during the 7 days following the first visit to the hospitalized kin). The caregiver will also complete a socio-demographic questionnaire and a Moral Distress Scale (MDS-R)
Hospitalized parent = One month after ICU discharge, a depression anxiety scale (HADS) and an acute stress scale (IES) will be performed
| Study group | Role | What they receive |
|---|---|---|
| Expérimental | Experimental | psychologist interview and psychometrics scales Receives: Other: interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute psychotraumatic impact of the visit on the child
Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points.
A score of 17 or greater is considered as clinically relevant
Measured: 7 days
Chronic psychotraumatic impact of the visit on the child
Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points.
A score of 17 or greater is considered as clinically relevant
Measured: 1 month
Psychological experience of the visit for the child
semi directive interview
Measured: 7 days
Parental, family and caregiver support provided to the child during and following the visit
semi directive interviews of caregiver/family
Measured: 1 month
Psychological experience of the visit according the child age
semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2019
- Study start26 Sep 2019
- Primary completion23 Nov 2020
- Study completion23 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive CareStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03954522
- Sponsor's protocol ID
- P/2018/354
- Acronym
- ENVIFAR
- Status last verified
- Jan 2025
- First submitted
- 9 Apr 2019
- Last updated
- 16 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation in Children of the Psychological Impact of the Visit of a Hospitalized Relative in ICU
- ClinicalTrials.gov ID
- NCT03954522
- Acronym / sponsor ID
- ENVIFAR / P/2018/354
- Keywords
- ICU, acute stress, PTSD, child, parent hospitalized
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 23 Nov 2020 (actual)
- Study completion
- 23 Dec 2020 (actual)
- First posted
- 17 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Expérimental | Experimental | Other: interviewpsychologist interview and psychometrics scales |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| interviewChild = A clinical interview (recorded, duration approximately 30 min) and a scale of acute stress (IES child) will be performed at 2 times (during the 7 days following the first visit of hospitalized kin and 1 month after the kin was discharged from ICU) Accompanying parent/kin = Semi-directive interviews (recorded - duration approximately 30 min) will be performed at the same time as those of the child and will be recorded. The parent/kin will also complete a socio-demographic questionnaire of the family group and a depression anxiety scale (HADS) Nursing staff = A semi-directive interview (recorded - duration approximately 30 min) will be performed only once (during the 7 days following the first visit to the hospitalized kin). The caregiver will also complete a socio-demographic questionnaire and a Moral Distress Scale (MDS-R) Hospitalized parent = One month after ICU discharge, a depression anxiety scale (HADS) and an acute stress scale (IES) will be performed | Other | Expérimental |
Primary outcome
Acute psychotraumatic impact of the visit on the child
Time frame: 7 days
Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
Chronic psychotraumatic impact of the visit on the child
Time frame: 1 month
Scale of stress (Child IES-R : Impact of Event Scale- Revised) : score calculated on 40 points. A score of 17 or greater is considered as clinically relevant
Psychological experience of the visit for the child
Time frame: 7 days
semi directive interview
Parental, family and caregiver support provided to the child during and following the visit
Time frame: 1 month
semi directive interviews of caregiver/family
Psychological experience of the visit according the child age
Time frame: 1 month
semi directive interview analysed in subgroup: comparison between child aged from 6 to 10 years old versus 11 to 14 years old
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing interview in people with Intensive Care and Child, run by Centre Hospitalier Universitaire de Besancon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute psychotraumatic impact of the visit on the child (time frame: 7 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2025.