Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

• Conditions: Inguinal Hernia; Children, Only; Umbilical Hernia; Urologic Surgery; Ambulatory Surgery

• Registration Number: NCT04206956
• Lead Sponsor: Centre Hospitalier de Saint-Brieuc

Brief Summary

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.

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 Timeline

• Study Start: 2019-10-14
• Study First Submitted: 2019-12-09
• Study First Submitted QC: 2019-12-19
• Study First Posted: 2019-12-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-09
• Last Update Posted: 2020-01-13
• Primary Completion: 2020-06
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chronic postsurgical pain in children	3 months after surgery	For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)
Children's preoperative anxiety	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)
Parents' preoperative anxiety	Preoperative: day of surgery	anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"
children's pain	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).

Trial Locations

Locations (1)

Centre Hospitalier de Saint-Brieuc; 🇫🇷 Saint-Brieuc, France