Pediatric Perioperative Satisfaction Questionnaire

Children Clinical Trial

Official title:

Development and Validation of a Perioperative Satisfaction Questionnaire in Children Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04608968
• Other study ID #: RECHMPL20_0346
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 29, 2022

Study information

• Verified date: May 2022
• Source: University Hospital, Montpellier
• Contact: sophie Bringuier
• Phone: 04 67 33 86 61
• Email: s-bringuierbranchereau[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 29, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 17 Years

Eligibility

Inclusion criteria:

• children 7 years and older

• elective surgery

• general anesthesia

• abiliy to understand and read questions

Exclusion criteria:

• emergency

• cognitive trouble

• intellectual disability

Related Conditions & MeSH terms

• Children
• Perioperative
• Satisfaction

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (8)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes, CHU de Lyon, CHU de Nantes, Clinique Saint Roch, Montpellier, University Hospital, Bordeaux, University Hospital, Grenoble, University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	postoperative pain intensity	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)
Secondary	perioperative anxiety level	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)