Screen Use by Children in a Pediatric Waiting Room and the Effect of an Environmental Intervention (PANDA)

November 11, 2026 updated by: Consorci Sanitari de l'Alt Penedès i Garraf

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
526

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
    • Barcelona
      • Vilanova i la Geltrú, Barcelona, Spain
        • Recruiting
        • CAPI Baix a Mar (CSAPG)
        • Contact:
        • Principal Investigator:
          • Estela Mansilla

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Pre-intervention

Children aged 2 to 8 years attended before the waiting room intervention is implemented
Experimental: Post-intervention

Children aged 2 to 8 years attended after implementation of the waiting room intervention and a one-month transition period
Other: Environmental waiting room intervention

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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of children using a screen device in the waiting room
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Consorci Sanitari de l'Alt Penedès i Garraf

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CSAPG-95

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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).

IPD Sharing Time Frame

After publication of main results of the study.

IPD Sharing Access Criteria

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 Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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