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Completed

NCT Number: NCT03977948

Qualitative and Systemic Assessment of a Nurse Intervention an Inpatient Child and His or Her Parents

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

semi-structured systemic interview

Other

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.

Primary outcomes

  1. Questionnaire

    Time frame: 1 day

    parents's and children's feelings about the nurse's preparation : Advantages and disadvantages, open- Questionnaire

Sponsors and collaborators

Lead sponsor

Centre Chirurgical Marie Lannelongue

Other

Registry information

Official study 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

Acronym: EVALINF

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 6, 2019
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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