Pediatric Perioperative Satisfaction Questionnaire

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Recruiting

CT.gov ID

NCT04608968

Collaborator

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

250

Enrollment

Location

27.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Perioperative Children Satisfaction

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 Design

Study Type:

Observational

Anticipated Enrollment :

250 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population

Actual Study Start Date :

Sep 1, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 29, 2022

Outcome Measures

Primary Outcome Measures

Children satisfaction after surgery [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)

Secondary Outcome Measures

postoperative pain intensity [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).
perioperative anxiety level [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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

7 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion criteria:

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

Exclusion criteria:

emergency
cognitive trouble
intellectual disability

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Uhmontpellier	Montpellier		France	34295

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Hospital, Montpellier

ClinicalTrials.gov Identifier:

NCT04608968

Other Study ID Numbers:

RECHMPL20_0346

First Posted:

Oct 30, 2020

Last Update Posted:

May 19, 2022

Last Verified:

May 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University Hospital, Montpellier

Validity

Questionnaire

Children

health quality of life

Self report

Study Results

No Results Posted as of May 19, 2022