Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children (ANXIDOU)
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|ClinicalTrials.gov Identifier: NCT04206956|
Recruitment Status : Recruiting
First Posted : December 20, 2019
Last Update Posted : January 13, 2020
|Condition or disease|
|Ambulatory Surgery Children, Only Inguinal Hernia Umbilical Hernia Urologic Surgery|
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|
|Estimated Enrollment :||135 participants|
|Official Title:||Anxiety and Chronic Postsurgical Pain Following Ambulatory Surgery in Children|
|Actual Study Start Date :||October 14, 2019|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||September 2020|
- 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)
- 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"
- 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).
- 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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04206956
|Contact: Gwenaelle Le Garff, Dremail@example.com|
|Contact: Catherine Bellotfirstname.lastname@example.org|
|Centre Hospitalier de Saint-Brieuc||Recruiting|
|Saint-Brieuc, France, 22027|
|Contact: Gwenaëlle Le Garff +33296017277 email@example.com|
|Contact: Catherine Bellot +33296017340 firstname.lastname@example.org|
|Principal Investigator: Claire Barbarot, Dr|
|Principal Investigator:||Claire Barbarot, Dr||Centre Hopsitalier Saint-Brieuc|