Anxiety Linked to the Surgery and / or Anesthesia Clinical Trial
Official title:
Inform and Reduce Pre-surgical Anxiety of the Child and His Parents: Interest of an Explanatory Movie About the Pathway of the Child in Pediatric Surgery.
| Verified date | November 2019 |
| Source | University Hospital, Montpellier |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of the study is to measure the interest of a movie explaining the path of the
children in surgery, in order to reduce the anxiety of the children and his parents.
This study is interventional, method randomized, controled, open-label, comparing two
parallel arms: anesthesist explanations versus anesthesist explanations + a movie
explanation.
| Status | Completed |
| Enrollment | 80 |
| Est. completion date | February 2016 |
| Est. primary completion date | February 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A to 12 Years |
| Eligibility |
Inclusion Criteria: - Patient who need a surgery - Patient that general condition fit with American Society of Anesthesiologists (ASA) I to III classification. - Old patient under age 12 - Patient whose parents agreed to participate Exclusion Criteria: - Patient with psychomotor limitations - Patient that had already been hospitalised for a surgery |
| Country | Name | City | State |
|---|---|---|---|
| France | Montpellier university hospital | Montpellier |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Montpellier |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The Yale Preoperative Anxiety Scale (m-YPAS) | Pre-surgical anxiety score of the children when separate from his parents, measured with the Yale Preoperative Anxiety Scale (m-YPAS) | the 1 surgery day at the time of the separation parents-children | |
| Secondary | Induction Compliance Checklist (ICC) | Score of "compliance" in the anesthetic induction measured by the ICC scale (hetero-assessment) | intraoperative | |
| Secondary | The agitation in recovery room | The agitation in recovery room measured by the scale of agitation in the awakening of a pediatric anesthesia (EPAD) (hetero-assessment) | First 15 minutes of the arrival in recovery room | |
| Secondary | psychometric validation of the SAS (self anxiety scale) | validation of the self report anxiety scale | up to postoperative day 30 |