Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children (ANXIDOU)

January 9, 2020 updated by: Centre Hospitalier de Saint-Brieuc
Prospective, monocentric, observationnal study. The primary objective of this study is to identify if presurgical child or/and parental anxiety is predictive of chronic postsurgical pain in abdominal or urologic ambulatory surgery.

Study Overview

Status

Unknown

Conditions

Detailed Description

The post surgical pain guidelines recommend to identify predictive factors, especially for vulnerable subjects.

For children, there is few data about predictive factors of postoperative pain after ambulatory surgery.

The objective of this study is to collect preoperative data (preoperative children's anxiety and parental anxiety) and postoperative data (postoperative pain measure: the day of surgery and 3 months after surgery) for children undergoing abdominal ou urologic ambulatory surgery, and to determine if there is a relationship between these data (Odds Ratio)

Study Type

Observational

Enrollment (Anticipated)

135

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 Contact Backup

Study Locations

  • France
      • Saint-Brieuc, France, 22027
        • Recruiting
        • Centre Hospitalier de Saint-Brieuc
        • Contact:
        • Principal Investigator:
          • Claire Barbarot, Dr

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 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children undergoing scheduled abdominal or urologic ambulatory surgery

Description

Inclusion Criteria:

  • child from 3 to 18 years old
  • undergoing scheduled urology or abdominal ambulatory surgery
  • child and parents speaking French
  • affiliation to national health insurance

Exclusion Criteria:

  • emergency surgery
  • lack of parents consent
  • no parental support on surgery day

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Children's preoperative anxiety
Time Frame: Preoperative : day of surgery

- For children younger than 12 : mYPAS (the Modified Yale Preoperative Anxiety Scale).

If the score is less than 24 : quiet child. If the score is greater than 24 : anxious child

- For children older than 12 : anxiety visual analog scale (VAS) From 0 (better) to 10 (worse)
Preoperative : day of surgery
Parents' preoperative anxiety
Time Frame: Preoperative: day of surgery
anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"
Preoperative: day of surgery
children's pain
Time Frame: postoperative: day of surgery
  • for children younger than 6: Evendol scale. From 0 (better) to 15 (worse)
  • for children older than 6: anxiety visual analog scale (VAS) From 0 (better) to 10 (worse).
postoperative: day of surgery
Chronic postsurgical pain in children
Time Frame: 3 months after surgery
For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)
3 months after surgery

Collaborators and Investigators

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

Sponsor

Centre Hospitalier de Saint-Brieuc

Investigators

  • Principal Investigator: Claire Barbarot, Dr, Centre Hopsitalier Saint-Brieuc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 14, 2019

Primary Completion (ANTICIPATED)

June 1, 2020

Study Completion (ANTICIPATED)

September 1, 2020

Study Registration Dates

First Submitted

December 9, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (ACTUAL)

December 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 13, 2020

Last Update Submitted That Met QC Criteria

January 9, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHSB-2019-05-P2-ANXIDOU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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