- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03977948
Qualitative and Systemic Assessment of a Nurse Intervention an Inpatient Child and His or Her Parents (EVALINF)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Le Plessis Robinson, France, 92350
- Hopital Marie Lannelongue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Questionnaire
Time Frame: 1 day
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parents's and children's feelings about the nurse's preparation : Advantages and disadvantages, open- Questionnaire
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1 day
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2018-A01623-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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