Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric

Surgical Intervention Clinical Trial

Official title:

Validation of a Pediatric Pictorial Version of the QOR-15 Postoperatory Functional Recovery Scale - QoR-15 Pédiatric

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04453410
• Other study ID #: 7732
• Status: Completed
• Start date: September 29, 2020
• Est. completion date: December 14, 2021

Study information

• Verified date: August 2023
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Consideration from the patient's point of view is an important step in improving postoperative functional recovery. The questionnaire Quality-of-recovery 15 (QoR-15) is a psychometrically validated questionnaire to measure the quality of postoperative functional recovery. it has been recommended in perioperative medecine however, this questionnaire was never adapted and validated for a pediatric surgical population. The main objective of this protocol is to study the validity, reliability, acceptability and feasibility in routine clinical practice of a pediatric pictorial version of the QoR-15 score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 14, 2021
• Est. primary completion date: September 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

Inclusion Criteria:

• Patient underage over 7 years and up to 17 years and 9 months
• Programming surgery as part of routine management
• Patient affiliated with a health insurance social
• Parental authority holders and the patient agreeing to participate in the study

Exclusion Criteria:

• Patients with severe sensory impairment in preoperation preventing reliable participation in the questionnaire
• Patients at risk of severe cognitive or sensory impairment in postoperative
• Patients with language difficulties in the language of administration of the questionnaire
• Patients who can not express their non-opposition to participation in the study
• Refusal of holders of parental authority and/or refusal of the patient to participate in the study

Related Conditions & MeSH terms

• Minor
• Surgical Intervention

Intervention

Other:
• Questionnaire Quality-of-recovery 15 (QoR-15)
Children will use the questionnaire Quality-of-recovery 15 (QoR-15)

Locations

Country	Name	City	State
France	Les Hôpitaux Universitaires de Strasbourg	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Questionnaire Quality-of-recovery 15 score	functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.	3 months