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NCT04079244: ALFA
Analysis of the Link Between Flow State and Preoperative Anxiety in Children Undergoing Playful Distraction
NA trial testing Video game in Children in 100 participants. Completed in 28 September 2019.
28 September 2019
Quick facts
| Lead sponsor | Rennes University Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | other |
| Enrollment | 100 |
| Start date | 14 May 2019 |
| Primary completion | 28 September 2019 |
| Estimated completion | 28 September 2019 |
| Sites | 1 location across France |
Drugs / interventions tested
- Video game
- Animated cartoon
Conditions studied
- Children — all drugs for Children →
- Ambulatory Surgery — all drugs for Ambulatory Surgery →
- General Anesthesia — all drugs for General Anesthesia →
Sponsor
Rennes University Hospital
Who can join
Adults 3 to 10, any sex, with Children or Ambulatory Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This study focuses on preoperative anxiety in children and non-drug methods to reduce anxiety. During surgery under general anesthesia, children may be anxious because of separation from their parents, fear of anesthesia, or loss of control. In order to reduce the anxiety of the child, anesthesiologists sometimes use an anxiolytic medicine. This premedication can reduce the anxiety of children. However, side effects are often observed as rebound anxiety after the operation or a delay to discharge from hospital. In recent years, alternative methods to premedication have been studied to reduce the anxiety of children. For example, video games and cartoons are distraction methods. Studies have shown that using a video game or cartoon during the waiting phases (in the room, when traveling, in the permutation room) reduces the anxiety of children and with the same efficiency as anxiolytic. In this study, the investigators will evaluate the effectiveness of a tablet game and a cartoon to reduce the anxiety of children.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04079244
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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Currently open trials in the same condition.
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Other Rennes University Hospital trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04079244 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Rennes University Hospital
- Last refreshed: 23 February 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04079244.
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