- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07702045
Dental Play Intervention Before Restorative Care in Children (Dental Play)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this pilot study is to evaluate whether a structured dental play intervention can reduce dental anxiety and improve behavioral cooperation and treatment acceptance among pediatric patients undergoing restorative care. Dental play involves familiarizing children with common dental instruments-such as mirrors, composite guns, and acid etch containers-by allowing them to interact with these items before their procedure.
This prospective randomized controlled pilot study will include participants aged 3-6 years who present to the pediatric dental clinic for restorative treatment. Participants included will be American Society of Anesthesiologists (ASA) Physical Status I or II and have no pre-existing behavioral or neurological conditions that could influence anxiety or cooperation.
Participants will be randomly assigned in a 1:1 ratio to one of two groups: an intervention group receiving a pre-appointment dental play session with a Child Life Specialist, and a control group receiving standard care without play intervention.
Previous research in medical settings demonstrates that play-based interventions can reduce anxiety and enhance patient understanding of healthcare procedures. However, limited evidence exists regarding the effectiveness of such interventions in dentistry. This study aims to explore the feasibility and preliminary impact of dental play interventions on pediatric patient behavior during restorative treatment.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Participants with no neurodivergent diagnosis
- Patients who at previous NP or hygiene visit has restorative needs that require administration of local anesthesia
- Patients who are within a score of 2-5 on the Houpt Scale
Exclusion Criteria:
- Patients with a diagnosed neurodivergent syndrome
- Patients who do not need restorative work
- Patients who are either score 1 or 6 on the Houpt Scale, to focus on patients with mild to moderate behavior challenges who may benefit most from the intervention.
- Patients with complex medical history that affect behavior and cooperation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Ingen indgriben: Control Group
Participants will proceed with their restorative appointment as scheduled, without any dental play intervention.
|
|
|
Eksperimentel: Intervention Group
Participants will arrive 30 minutes prior to their scheduled appointment and engage in a structured 30-minute dental play session with a Certified Child Life Specialist.
The session will involve safe, non-functional dental materials such as white coats, gloves, mirrors, typodonts, and empty acid etch containers, allowing children to explore and interact with these items in a supportive environment.
|
Participants will arrive 30 minutes prior to their scheduled appointment and engage in a structured 30-minute dental play session with a Certified Child Life Specialist.
The session will involve safe, non-functional dental materials such as white coats, gloves, mirrors, typodonts, and empty acid etch containers, allowing children to explore and interact with these items in a supportive environment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Measure the impact on play therapy for dental patients
Tidsramme: 1.5 hours
|
To understand the impact on play therapy for dental patients according to the quantitative Houpt Behavior rating scale.
|
1.5 hours
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Gayatri Malik, DMD, PhD, Geisinger Clinic
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- 2026-0547
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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Kliniske forsøg med Tandlægeskræk hos børn
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