- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Noemí Casaponsa
- Telefonnummer: 43197 0034938960025
- E-post: recerca@csapg.cat
Studieorter
-
-
Barcelona
-
Vilanova i la Geltrú, Barcelona, Spanien
- Rekrytering
- CAPI Baix a Mar (CSAPG)
-
Kontakt:
- Noemí Casaponsa
- Telefonnummer: 43197 0034938960025
- E-post: recerca@csapg.cat
-
Huvudutredare:
- Estela Mansilla
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Sekventiell tilldelning
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Inget ingripande: Pre-intervention
Children aged 2 to 8 years attended before the waiting room intervention is implemented |
|
|
Experimentell: 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. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Proportion of children using a screen device in the waiting room
Tidsram: 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
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- CSAPG-95
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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).
Tidsram för IPD-delning
After publication of main results of the study.
Kriterier för IPD Sharing Access
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.
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
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