- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07719205
Tactile Pre-Visit Imagery
Tactile Pre-Visit Imagery Effect on Behavior of Children During Dental Procedures
In pediatric dentistry, our primary goals are to prevent dental caries and, when necessary, provide treatment in a safe and comforting environment that minimizes anxiety for young patients. By familiarizing young patients with the steps involved in common dental procedures, tactile pre-visit imagery booklets can reduce the fear of the unknown.
Study Objective/Purpose: The purpose of this study is to determine whether tactile pre-visit imagery could reduce dental anxiety and fear in pediatric patients prior to their first restorative procedure. An additional aspect of this study entails assessing the patient's behavior and determining if it improves with the use of a tactile pre-visit imagery booklet.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
California
-
Los Angeles, California, Forenede Stater, 90089
- Rekruttering
- USC Herman Ostrow School of Dentistry - Pediatric Dental Clinic
-
Kontakt:
- Catherine Pham
- Telefonnummer: 213-740-0412
- E-mail: cmpham@usc.edu
-
Santa Ana, California, Forenede Stater, 92704
- Rekruttering
- Altamed Dental Clinic
-
Kontakt:
- Alyssa Nowlen
- Telefonnummer: 888-499-9303
- E-mail: annowlen@usc.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Children aged 4-10 years
- ASA I or II
- Patients who have NOT had dental treatment before
- Patients needing at least ONE composite filling or stainless steel crown [CP1] with nitrous oxide and local anesthesia (composite filling must be done at the first treatment visit)
- Parents and children must speak English or Spanish
Exclusion Criteria:
- Children with developmental delays or cognitive impairments that may impact their ability to participate in pre-visit imagery activities
- Patients with visual or tactile disabilities associated for a particular medical condition or as reported on their medical history form
- Patients who refuse to wear nitrous hood
- Emergency dental appointments
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Tactile Previsit Imagery
Receives tactile previsit imagery booklet
|
Physical Booklet that walks patient through all materials used during the dental treatmne and contains physical items that are going to be used so that patient can touch and feel.
|
|
Ingen indgriben: No Tactile Previsit Imagery
No additional previsit imagery
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dental Anxiety
Tidsramme: At baseline (pre-intervention) and immediately after treatment (post-intervention)
|
Change in dental anxiety before and after treatment.
The Venham Picture test is used to measure the child's anxiety.
The scores from the Venham Picture test will be compared between pre- and post- treatment to determine changes in dental anxiety.
|
At baseline (pre-intervention) and immediately after treatment (post-intervention)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Behavior
Tidsramme: At baseline (preintervention) and immediately after treatment (post-intervention)
|
Change in behavior/cooperation of patient before and after treatment.
Child's behavior will be measured using the Frankl Behavior score.
The Frankl score will be recorded pre- and post-treatment to determine a change in behavior.
|
At baseline (preintervention) and immediately after treatment (post-intervention)
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
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
- HS-25-00212
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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