NCT04453410

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 1, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 29, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2021

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1 year

First QC Date

June 26, 2020

Last Update Submit

August 21, 2023

Conditions

Keywords

questionnaire Quality-of-recovery 15 (QoR-15)

Outcome Measures

Primary Outcomes (1)

  • Questionnaire Quality-of-recovery 15 score

    functional recovery score Questionnaire Quality-of-recovery 15 in pictorial version established at J1 postoperatively.

    3 months

Interventions

Children will use the questionnaire Quality-of-recovery 15 (QoR-15)

Eligibility Criteria

Age7 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Minor patient over 7 years and up to 17 years and 9 months who have a programming surgery as part of routine management

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Les Hôpitaux Universitaires de Strasbourg

Strasbourg, 67098, France

Location

Related Publications (1)

  • Noll E, De Angelis V, Bopp C, Chauvin C, Talon I, Bennett-Guerrero E, Lefebvre F, Pottecher J. Pictorial adaptation of the quality of recovery 15 scale and psychometric validation into a pediatric surgical population. Sci Rep. 2023 Aug 28;13(1):14085. doi: 10.1038/s41598-023-40673-w.

Study Design

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

Study Record Dates

First Submitted

June 26, 2020

First Posted

July 1, 2020

Study Start

September 29, 2020

Primary Completion

September 29, 2021

Study Completion

December 14, 2021

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations