Hemophilia ANCT05754619
Emotions in the Communication and Relationship Styles of Parents With Hemophilic Children.
An observational study of Hemophilia A, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age. The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Read more about this study
- Who is it for?
- Ages 10 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Hemophilia A
- How many people
- 10 participants
- Where
- 1 siteItaly
- Study dates
- 14 Oct 2022to 14 May 2023
- How long will I take part?
- 7 Months
- Phase
- Observational
- 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 10 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: the study includes 20 caregivers, parents of childrens (10-18 yo) with Haemophilia
Who may be able to join
- Haemophilia A
Who cannot join
- No Informed Conset
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
FPG
Roma, 00168
Raimondo De Cristofaro, 0630156329, raimondo.decristofaro@policlinicogemelli.it
About this study
Official title: Le Emozioni Negli Stili di Comunicazione e Relazione di Genitori Con Figli Emofilici.
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.
The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.
Read the detailed description
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.he diagnosis of hemophilia brings with it, in parents, fears, guilt, overprotective temptations that push us to act rather than to narrate the meaning of that need of ours, caregiving modes that risk engaging our operational side at the expense of recognizing ourselves and our feelings and emotions. We have no reason to think that that traumatic stimulus installs in us an atypical mode of resorting to our emotional intelligence. Therefore, it becomes even more significant to study parent-child communication processes on this target, to observe whether and how the adult's emotional area finds its place and expression. On the results of this work, the foundations could be laid for subsequent observational or interventional studies.
- Conditions
- Hemophilia A
- Medical subject headings
- Hemophilia A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients with HA | 20 parents with hemophilic children. The sample will consist of 10 mothers and 10 fathers. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The study aims to highlight the ways in which the caregivers of haemophiliac children and young people manage and express their emotional experience through interviews and reports
The study aims to highlight the ways in which care givers of hemophilic children and youth manage and express their emotional experiences. It therefore intends to answer these questions:
- How do parents of hemophilic children and youth contribute to the development of their children's emotional intelligence?
- What adult role model do they consciously or unconsciously propose in relation to frailties and fears?
- How do they guide their children in dealing with frailties and fears?
- Does the communication process they construct integrate their experience and is it congruent with it?
Measured: 1 month
Secondary outcomes (1)
opportunity for mirroring the parents interviewed by which they construct participation in their child's life in the experience of illness with interview and questionnaire.
This study represents a potential opportunity for mirroring the interviewed parents, who in nonjudgmental observation will be able to see themselves and the unconscious dynamics by which they construct participation in their child's life in the experience of illness. Where interviewed parents show willingness and interest, a thirty-minute follow-up meeting will be held fifteen days/one month later, which will aim to accommodate their experience following the stimuli offered by the experience with our team. The main purpose, then, is in accompanying these people to process what will have emerged in the interview-interview
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start14 Oct 2022
- Primary completion14 May 2023 (estimated)
- Study completion14 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 10 participants (estimated)
- Target duration
- 7 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, De Cristofaro Raimondo, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Raimondo De Cristofaro, MD, Principal investigator, Fondazione Policlinico Universitario A.Gemelli IRCCS Rome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754619
- Sponsor's protocol ID
- 4913
- Status last verified
- Feb 2023
- First submitted
- 3 Feb 2023
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Le Emozioni Negli Stili di Comunicazione e Relazione di Genitori Con Figli Emofilici.
- ClinicalTrials.gov ID
- NCT05754619
- Acronym / sponsor ID
- 4913
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 14 Oct 2022 (actual)
- Primary completion
- 14 May 2023 (estimated)
- Study completion
- 14 May 2023 (estimated)
- First posted
- 6 Mar 2023 (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.
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.
The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.
Detailed description
Severe hemophilia is a rare, inherited, X-linked disorder. Currently, standard therapy involves ev infusion of drugs from a very young age.The diagnosis of hemophilia is a traumatic event for the parents, even before the unborn child. The management of the hemophilia patient involves the whole family. Also in relation to its heredity.Focus on the ways in which parents of children with hemophilia manage their emotional experience.he diagnosis of hemophilia brings with it, in parents, fears, guilt, overprotective temptations that push us to act rather than to narrate the meaning of that need of ours, caregiving modes that risk engaging our operational side at the expense of recognizing ourselves and our feelings and emotions. We have no reason to think that that traumatic stimulus installs in us an atypical mode of resorting to our emotional intelligence. Therefore, it becomes even more significant to study parent-child communication processes on this target, to observe whether and how the adult's emotional area finds its place and expression. On the results of this work, the foundations could be laid for subsequent observational or interventional studies.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 7 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with HA | – | –20 parents with hemophilic children. The sample will consist of 10 mothers and 10 fathers. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- the study includes 20 caregivers, parents of childrens (10-18 yo) with Haemophilia
Key inclusion criteria (1 listed)
- Haemophilia A
Key exclusion criteria (1 listed)
- No Informed Conset
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The study aims to highlight the ways in which the caregivers of haemophiliac children and young people manage and express their emotional experience through interviews and reports
Time frame: 1 month
The study aims to highlight the ways in which care givers of hemophilic children and youth manage and express their emotional experiences. It therefore intends to answer these questions: * How do parents of hemophilic children and youth contribute to the development of their children's emotional intelligence? * What adult role model do they consciously or unconsciously propose in relation to frailties and fears? * How do they guide their children in dealing with frailties and fears? * Does the communication process they construct integrate their experience and is it congruent with it?
1 secondary outcome
opportunity for mirroring the parents interviewed by which they construct participation in their child's life in the experience of illness with interview and questionnaire.
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
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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.
Raimondo De Cristofaro, MD principal investigator
Fondazione Policlinico Universitario A.Gemelli IRCCS Rome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 6 Mar 2023. 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 Italy. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raimondo De Cristofaro, MD (0630156329, raimondo.decristofaro@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The study aims to highlight the ways in which the caregivers of haemophiliac children and young people manage and express their emotional experience through interviews and reports (time frame: 1 month). 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 6 Mar 2023.