Anxiety StateEVALINFNCT03977948
Qualitative and Systemic Assessment of a Nurse Intervention an Inpatient Child and His or Her Parents
An observational study of Anxiety State and Surgery, run by Centre Chirurgical Marie Lannelongue at 1 site in France.
Trial summary
The hospitalization of a child for cardiac surgery is a major event in a family's life. Some factors induced by surgery can have serious psychological consequences and cause high stress and anxiety in the child but also in the parents. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Anxiety State, Surgery, Pediatric Disorder
- What is being tested?
- semi-structured systemic interview
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 16 Oct 2018to 31 Aug 2019
- 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 6 to 12 years
- All sexes
- Child
Study population: The child with his family
Who may be able to join
- Children aged 6 to 12 years hospitalized for open-heart surgery
- Children who have participated in the daily surgical preparation activity provided by M3 nurses to families whose child is hospitalized for open-heart surgery.
- Ability to understand and speak French
- The parent (biological or adoptive) must have participated in the activity of preparation for surgery.
Who cannot join
- Child with a psychological pathology diagnosed in the medical file or notified by the parents at the first contact (autism, depression...)
- Children with cognitive problems that do not allow the interviews diagnosed in the medical file or notified by the parents at the first contact to take place
- Genetic syndrome
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Qualitative and Systemic Assessment of a Family Health Nurse Intervention Through Play, Which Aims to Prepare an Inpatient Child and His or Her Parents for Heart Surgery
The hospitalization of a child for cardiac surgery is a major event in a family's life. Some factors induced by surgery can have serious psychological consequences and cause high stress and anxiety in the child but also in the parents. Many interventions have been tested to reduce this anxiety generated by apprehension of the surgical procedure, but there is no evidence to date that would allow health care services to effectively prepare these families for surgery. The authors encourage researchers to continue research on this subject in order to confirm or refute their results.
Read the detailed description
The hospitalization of a child for surgery is a major event that can disrupt a family's life. Indeed, whatever the degree of severity and type of pathology that leads to hospitalization, a stay in hospital is often synonymous with stress and fear, both for the child and for parents. A lack of knowledge of care procedures, the feeling of not being able to control the situation and a lack of explanations in terms adapted to their age are all factors that contribute to the vulnerability of children hospitalized for surgery.
Preoperative anxiety can be defined as an overflow of the child's ability to cope with stress, induced by the fear of surgery. Significant preoperative anxiety could increase the risk of post-operative complications and promote emotional and behavioural disorders such as: insecurity, guilt, anger, anger, regression, withdrawal or rebellion, it could also have the effect of limiting the child's ability to cope with surgery, encouraging negative behaviours related to health care, but also inhibiting post-operative recovery. These behavioural disorders induced by preoperative anxiety may persist once hospitalization is completed and the family returns home. In addition, if the operating experience is negative, the child may develop separation anxiety or even phobia following surgery and in extreme cases acute stress or even post-traumatic stress. The risk for the child to develop one of these disorders following surgery is increased by the frequency and duration of the anxiety episodes to which he or she will be subjected.
Parents of children hospitalized for surgery would also experience very high stress, related to their perception of their child's state of health, apprehension of invasive treatments, as well as fear of sequelae that could be caused by certain invasive treatments or because of their child's pathology. It is therefore important, during hospitalization and surgery, to take into consideration the anxiety of the child, but also of his or her parents, and to consider how best to manage this anxiety in order to prevent complications.
- Conditions
- Anxiety State, Surgery, Pediatric Disorder
- Being tested
- semi-structured systemic interview
- Keywords
- cardiac surgery pediatric, preoperative anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semi-structured systemic interviewOther
Semi-structured systemic interviews will be conducted with families who have benefited from the preparation for surgery through play. Other tools such as the logbook and the socio-demographic questionnaire will also be used. The themes that will emerge from these interviews will provide a better understanding of what these families are going through, how the proposed intervention may or may not have met their expectations, and provide insights so that health care services can build their own surgical preparation programs.
What is being measured
The primary outcome is the main question the study is designed to answer.
Questionnaire
parents's and children's feelings about the nurse's preparation : Advantages and disadvantages, open- Questionnaire
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start16 Oct 2018
- Primary completion15 Apr 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety StateStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Chirurgical Marie Lannelongue
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03977948
- Sponsor's protocol ID
- 2018-A01623-52
- Acronym
- EVALINF
- Status last verified
- May 2019
- First submitted
- 20 May 2019
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Qualitative and Systemic Assessment of a Family Health Nurse Intervention Through Play, Which Aims to Prepare an Inpatient Child and His or Her Parents for Heart Surgery
- ClinicalTrials.gov ID
- NCT03977948
- Acronym / sponsor ID
- EVALINF / 2018-A01623-52
- Conditions
- Anxiety State, Surgery, Pediatric Disorder
- Keywords
- cardiac surgery pediatric, preoperative anxiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Chirurgical Marie LannelongueUniversity, hospital or other
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 6 Jun 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.
The hospitalization of a child for cardiac surgery is a major event in a family's life. Some factors induced by surgery can have serious psychological consequences and cause high stress and anxiety in the child but also in the parents. Many interventions have been tested to reduce this anxiety generated by apprehension of the surgical procedure, but there is no evidence to date that would allow health care services to effectively prepare these families for surgery. The authors encourage researchers to continue research on this subject in order to confirm or refute their results.
Detailed description
The hospitalization of a child for surgery is a major event that can disrupt a family's life. Indeed, whatever the degree of severity and type of pathology that leads to hospitalization, a stay in hospital is often synonymous with stress and fear, both for the child and for parents. A lack of knowledge of care procedures, the feeling of not being able to control the situation and a lack of explanations in terms adapted to their age are all factors that contribute to the vulnerability of children hospitalized for surgery.
Preoperative anxiety can be defined as an overflow of the child's ability to cope with stress, induced by the fear of surgery. Significant preoperative anxiety could increase the risk of post-operative complications and promote emotional and behavioural disorders such as: insecurity, guilt, anger, anger, regression, withdrawal or rebellion, it could also have the effect of limiting the child's ability to cope with surgery, encouraging negative behaviours related to health care, but also inhibiting post-operative recovery. These behavioural disorders induced by preoperative anxiety may persist once hospitalization is completed and the family returns home. In addition, if the operating experience is negative, the child may develop separation anxiety or even phobia following surgery and in extreme cases acute stress or even post-traumatic stress. The risk for the child to develop one of these disorders following surgery is increased by the frequency and duration of the anxiety episodes to which he or she will be subjected.
Parents of children hospitalized for surgery would also experience very high stress, related to their perception of their child's state of health, apprehension of invasive treatments, as well as fear of sequelae that could be caused by certain invasive treatments or because of their child's pathology. It is therefore important, during hospitalization and surgery, to take into consideration the anxiety of the child, but also of his or her parents, and to consider how best to manage this anxiety in order to prevent complications.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Age groups
- Child
- Study population
- The child with his family
Key inclusion criteria (4 listed)
- Children aged 6 to 12 years hospitalized for open-heart surgery
- Children who have participated in the daily surgical preparation activity provided by M3 nurses to families whose child is hospitalized for open-heart surgery.
- Ability to understand and speak French
- The parent (biological or adoptive) must have participated in the activity of preparation for surgery.
Key exclusion criteria (3 listed)
- Child with a psychological pathology diagnosed in the medical file or notified by the parents at the first contact (autism, depression...)
- Children with cognitive problems that do not allow the interviews diagnosed in the medical file or notified by the parents at the first contact to take place
- Genetic syndrome
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 |
|---|---|---|
| semi-structured systemic interviewSemi-structured systemic interviews will be conducted with families who have benefited from the preparation for surgery through play. Other tools such as the logbook and the socio-demographic questionnaire will also be used. The themes that will emerge from these interviews will provide a better understanding of what these families are going through, how the proposed intervention may or may not have met their expectations, and provide insights so that health care services can build their own surgical preparation programs. | Other | – |
Primary outcome
Questionnaire
Time frame: 1 day
parents's and children's feelings about the nurse's preparation : Advantages and disadvantages, open- Questionnaire
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 4 Aug 2021.
- Individual participant dataSharing planned: No
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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?
An observational study of Anxiety State and Surgery, run by Centre Chirurgical Marie Lannelongue 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 4 inclusion and 3 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 4 Aug 2021. 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?
Questionnaire (time frame: 1 day). 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 4 Aug 2021.