NCT03977948

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 20, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 6, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2019

Completed
Last Updated

August 4, 2021

Status Verified

May 1, 2019

Enrollment Period

6 months

First QC Date

May 20, 2019

Last Update Submit

August 3, 2021

Conditions

Keywords

cardiac surgery pediatricpreoperative anxiety

Outcome Measures

Primary Outcomes (1)

  • Questionnaire

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

    1 day

Interventions

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.

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

The child with his family

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Marie Lannelongue

Le Plessis-Robinson, 92350, France

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2019

First Posted

June 6, 2019

Study Start

October 16, 2018

Primary Completion

April 15, 2019

Study Completion

August 31, 2019

Last Updated

August 4, 2021

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations