An observational study in Ambulatory Surgery, Children, Only and Inguinal Hernia, sponsored by Centre Hospitalier de Saint-Brieuc. Status unknown at 1 site in France. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Centre Hospitalier de Saint-Brieuc · Observational
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.
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)
543 studies on the registry are indexed under Hernia, Inguinal; 92 are open to participants now.
This study's planned enrollment of 135 is close to the median of 134 across 137 observational studies indexed under Hernia, Inguinal.
Browse Hernia, Inguinal studies →Centre Hospitalier de Saint-Brieuc is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Children undergoing scheduled abdominal or urologic ambulatory surgery
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Children's preoperative anxiety
- 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)
Time frame: Preoperative : day of surgery
Parents' preoperative anxiety
anxiety visual analog scale (VAS) From 0 (better) to 10 (worse). More than 3/10 means "anxious"
Time frame: Preoperative: day of surgery
children's pain
* 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).
Time frame: postoperative: day of surgery
Chronic postsurgical pain in children
For all children, score PPMP (Postoperative Pain Measure for Parents) From 0 (better) to 10 (worse)
Time frame: 3 months after surgery
Started Oct 2019 (actual). Primary completion is estimated for Jun 2020, 8 months after the start.
Of 51 non-industry observational studies under Hernia, Inguinal, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 68. This study's planned 8 months is below that.
Counting every sponsor, half of 57 studies reached it within 18 months; a quarter within 9 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier de Saint-Brieuc