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Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04206956
Acronym
ANXIDOU
Enrollment
135
Registered
2019-12-20
Start date
2019-10-14
Completion date
2020-09-30
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Surgery, Children, Only, Inguinal Hernia, Umbilical Hernia, Urologic Surgery

Keywords

pediatric department, children, chronic postsurgical pain, perioperative anxiety

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)

Interventions

None listed

Sponsors

Centre Hospitalier de Saint-Brieuc
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Children's preoperative anxietyPreoperative : 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 anxietyPreoperative: day of surgeryanxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means anxious
children's painpostoperative: 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).
Chronic postsurgical pain in children3 months after surgeryFor all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)

Countries

France

Contacts

Primary ContactGwenaelle Le Garff, Dr
gwenaelle.legarff@armorsante.bzh+33296017277
Backup ContactCatherine Bellot
catherine.bellot@armorsante.bzh+33296017340

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026