Trials / Terminated
TerminatedNCT03324828
Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
Double-blind Randomized Clinical Trial to Compare Presurgery Anxiolysis in Children Treated With Hydroxyzine Versus Non-pharmacological Intervention (Distractoria Technique Clown)
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 170 (actual)
- Sponsor
- Hospital San Carlos, Madrid · Academic / Other
- Sex
- All
- Age
- 2 Years – 16 Years
- Healthy volunteers
- Not accepted
Summary
This study evaluate the change in preoperative anxiety, baseline (M1) and pre-induction anxiety levels (M3), as shown by children undergoing MAS determined by the m-YPAS scale in the different APO management groups.Patients will be allocated in one of this four groups: hydroxyzine+clown; hydroxyzine alone, clowns alone or nothing
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Hydroxyzine | Hydroxyzine solution |
| OTHER | Clowns intervention | Clowns intervention |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2020-05-29
- Completion
- 2020-05-29
- First posted
- 2017-10-30
- Last updated
- 2020-08-11
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT03324828. Inclusion in this directory is not an endorsement.