Pediatric Perioperative Satisfaction Questionnaire

November 25, 2024 updated by: University Hospital, Montpellier

Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population

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

Study Overview

Status

Recruiting

Conditions

Detailed Description

Step 1 : development of the questiontionnaire Face to face interview to report the satisfaction of the children after surgery and to identify recurrent themes to generate questions.

Step 2 : validation of the questionnaire Evaluation of the psychometric validity of the final questionnaire

Study Type

Observational

Enrollment (Estimated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 13 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

children 7 years and older after surgery

Description

Inclusion criteria:

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

Exclusion criteria:

  • emergency
  • cognitive trouble
  • intellectual disability

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children satisfaction after surgery
Time Frame: at discharge of hospital ( from the day of surgery up 14 days)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative pain intensity
Time Frame: at discharge of hospital ( from the day of surgery up 14 days)
to assess the level of children postoperative pain intensity (from the day of surgery to 2 weeks). Pain was assessed using the Face Pain Scale revised tool (0-10).
at discharge of hospital ( from the day of surgery up 14 days)
perioperative anxiety level
Time Frame: at discharge of hospital ( from the day of surgery up 14 days)
to assess perioperative anxiety level using the Visual Analog Scale (0-10) of children after surgery (from the day of surgery to 2 weeks)
at discharge of hospital ( from the day of surgery up 14 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Collaborators

University Hospital, Bordeaux
Centre Hospitalier Universitaire de Nīmes
University Hospital, Grenoble
University Hospital, Toulouse
Clinique Saint Roch, Montpellier
CHU de Lyon
CHU de Nantes

Investigators

  • Study Director: Christophe DADURE, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 24, 2020

First Submitted That Met QC Criteria

October 24, 2020

First Posted (Actual)

October 30, 2020

Study Record Updates

Last Update Posted (Estimated)

November 27, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RECHMPL20_0346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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