Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03977948 |
| Other study ID # |
2018-A01623-52 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 16, 2018 |
| Est. completion date |
August 31, 2019 |
Study information
| Verified date |
May 2019 |
| Source |
Centre Chirurgical Marie Lannelongue |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
