- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07933926
Screen Use by Children in a Pediatric Waiting Room and the Effect of an Environmental Intervention (PANDA)
Screen Use by Children in the Pediatric Waiting Room and Effect of an Environmental Intervention: a Before-and-after Study
The goal of this clinical trial is to learn if changing the physical environment of a pediatric waiting room can reduce the use of screen devices (such as mobile phones and tablets) by children aged 2 to 8 years while they wait for their appointment. The main questions it aims to answer are:
- Does the proportion of children who use a screen device in the waiting room decrease after the intervention?
- What types of digital content do children use most often in the waiting room, and which sociodemographic factors are associated with screen use? Researchers will compare children seen before the waiting room was changed with children seen after the change to see if fewer children use screen devices.
The intervention consists of posters for parents and caregivers on the benefits of reducing screen time, play and educational materials (books, puzzles, board games, and educational toys), and boards or murals where children and adults can draw or write.
Parents or legal guardians of participating children will complete a short anonymous survey on a tablet in the waiting room.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
Excessive screen use in childhood has been associated with obesity, language delay, hyperactivity, and sleep problems, and the American Academy of Pediatrics recommends limiting screen time to a maximum of one hour per day in children under 6 years. Screen devices are frequently used in pediatric waiting rooms, but no intervention studies have focused on the waiting room as a setting to reduce screen exposure.
This quasi-experimental before-and-after study will be conducted in the Pediatrics Service of the Baix a Mar Integrated Primary Care Center (Consorci Sanitari de l'Alt Penedès i Garraf). Two independent samples will be recruited consecutively: one before and one after implementation of the environmental intervention, which is an organizational decision of the service and is independent of participation in the study. Data collection will stop for one month after implementation to allow the intervention to settle in. Parents or legal guardians will complete an anonymous, self-administered 11-item electronic survey (REDCap) designed ad hoc and piloted with 10 parents. Screen use during the consultation will be recorded separately by the healthcare professional.
The primary analysis will compare the proportion of children using screen devices in the waiting room between the pre- and post-intervention periods with the chi-square test or Fisher's exact test, with logistic regression adjusted for age, sex, and waiting time. Based on a pilot survey of 100 parents (21% screen use), 263 participants per period are needed to detect a reduction to 10.5% (two-sided alpha 0.05, power 80%), allowing for 20% non-evaluable questionnaires. Analysts will be blinded to the study period.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Noemí Casaponsa
- Telefonní číslo: 43197 0034938960025
- E-mail: recerca@csapg.cat
Studijní místa
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, Španělsko
- Nábor
- CAPI Baix a Mar (CSAPG)
-
Kontakt:
- Noemí Casaponsa
- Telefonní číslo: 43197 0034938960025
- E-mail: recerca@csapg.cat
-
Vrchní vyšetřovatel:
- Estela Mansilla
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Children aged 2 to 8 years attended at the Pediatrics Service of CAPI Baix a Mar (CSAPG)
- Waiting time of at least 5 minutes in the waiting room before the consultation
Exclusion Criteria:
- Severe visual or hearing impairment that limits usual interaction with screen devices
- Diagnosis of a severe neurodevelopmental disorder, according to the investigator's judgment (for example, severe autism spectrum disorder)
- Parent or legal guardian unable to complete the survey because of a language barrier or other limitations
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Nerandomizované
- Intervenční model: Sekvenční přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Žádný zásah: Pre-intervention
Children aged 2 to 8 years attended before the waiting room intervention is implemented |
|
|
Experimentální: Post-intervention
Children aged 2 to 8 years attended after implementation of the waiting room intervention and a one-month transition period |
Modification of the physical environment of the pediatric waiting room to reduce screen use: posters for parents and caregivers on the benefits of reducing screen exposure; play and educational materials (books, puzzles, board games, and educational toys); and boards or murals for children and adults to draw or write on. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of children using a screen device in the waiting room
Časové okno: Baseline
|
Proportion of children who use any screen device (mobile phone, tablet, game console, or similar) in the waiting room before the consultation, reported by the parent or legal guardian in the study survey. Screen use is defined as the child actively watching or handling a screen device. |
Baseline
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- CSAPG-95
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
IPD (without personal identification data) could be shared by requirement from other researchers after the end of the study, and only for research purposes and previous approval of promotor center of the study (CSAPG). Anyway, Spanish and European Union legal policy about data protection will strictly be followed (IPD will not be transferred outside European Union).
Časový rámec sdílení IPD
After publication of main results of the study.
Kritéria přístupu pro sdílení IPD
IPD will be shared only for scientific research purposes and following the Spanish and European Union normative law about data protection. The requirements will be directed to the IP of the study. The IP will evaluate the request to verify and evaluate the data that is requested and the purposes for which it is requested. Next, the IP will transfer the request to the promotor center the study for the final decision.
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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