Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03977948
Recruitment Status : Active, not recruiting
First Posted : June 6, 2019
Last Update Posted : June 10, 2019
Information provided by (Responsible Party):
Centre Chirurgical Marie Lannelongue

Brief 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.

Condition or disease Intervention/treatment
Anxiety State Surgery Pediatric Disorder Other: semi-structured systemic interview

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 10 participants
Observational Model: Other
Time Perspective: Prospective
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
Actual Study Start Date : October 16, 2018
Actual Primary Completion Date : April 15, 2019
Estimated Study Completion Date : August 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Intervention Details:
  • Other: semi-structured systemic interview
    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 Outcome Measures :
  1. Questionnaire [ Time Frame: 1 day ]
    parents' feelings about the nurse's preparation : Advantages and disadvantages, open-ended question, Questionnaire

  2. Questionnaire [ Time Frame: 1 day ]
    children's feelings about the nurse's preparation : Advantages and disadvantage, open-ended question, Questionnaire

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
The child with his family

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03977948

Layout table for location information
Hôpital Marie Lannelongue
Le Plessis Robinson, France, 92350
Sponsors and Collaborators
Centre Chirurgical Marie Lannelongue

Layout table for additonal information
Responsible Party: Centre Chirurgical Marie Lannelongue Identifier: NCT03977948     History of Changes
Other Study ID Numbers: 2018-A01623-52
First Posted: June 6, 2019    Key Record Dates
Last Update Posted: June 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Chirurgical Marie Lannelongue:
cardiac surgery pediatric
preoperative anxiety