NCT04608968

Brief Summary

The aim of this study is to develop and validate a self-report questionnaire to evalutate the satisfaction of the children after surgery.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Sep 2020

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

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 Progress91%
Sep 2020Dec 2026

Study Start

First participant enrolled

September 1, 2020

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 30, 2020

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

November 27, 2024

Status Verified

November 1, 2024

Enrollment Period

6.3 years

First QC Date

September 24, 2020

Last Update Submit

November 25, 2024

Conditions

PerioperativeChildrenSatisfaction

Keywords

ValidityQuestionnaireChildrenhealth quality of lifeSelf report

Outcome Measures

Primary Outcomes (1)

  • Children satisfaction after surgery

    to develop a questionnaire (score 0 to 100) to assess the satisfaction of children after surgery (from the day of surgery to 2 weeks)

    at discharge of hospital ( from the day of surgery up 14 days)

Secondary Outcomes (2)

  • postoperative pain intensity

    at discharge of hospital ( from the day of surgery up 14 days)

  • perioperative anxiety level

    at discharge of hospital ( from the day of surgery up 14 days)

Eligibility Criteria

Age7 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

children 7 years and older after surgery

You may qualify if:

  • children 7 years and older
  • elective surgery
  • general anesthesia
  • abiliy to understand and read questions

You may not qualify if:

  • emergency
  • cognitive trouble
  • intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Uhmontpellier

Montpellier, Montpellier, 34295, France

RECRUITING

UH Bordeaux

Bordeaux, France

RECRUITING

UH Grenoble

Grenoble, France

RECRUITING

UH Nîmes

Nîmes, France

RECRUITING

UH Reims

Reims, France

RECRUITING

UH Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Personal Satisfaction

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Christophe DADURE, PhD

    University Hospital, Montpellier

    STUDY DIRECTOR

Central Study Contacts

sophie Bringuier

CONTACT

04 67 33 86 61s-bringuierbranchereau@chu-montpellier.fr

Study Design

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

Study Record Dates

First Submitted

September 24, 2020

First Posted

October 30, 2020

Study Start

September 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

November 27, 2024

Record last verified: 2024-11

Locations

FR(6)