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Impact van therapiehonden op de angst en het gedrag van kinderen tijdens lokale anesthesie voor tandheelkundige ingrepen

7 november 2026 bijgewerkt door: James R. Boynton, University of Michigan

Impact van therapiehonden op angst en gedrag van pediatrische tandheelkundige patiënten tijdens lokale anesthesie: een gerandomiseerde gecontroleerde studie

Therapy dogs in dental offices might help anxious children during dental care. Therapy dogs might help children during injection of local anesthetic, when we inject numbing medication before working on the teeth. The goal of this study is to learn if having a therapy dog with a child during the injection of numbing medication helps children to be more comfortable at the dentist's office. This study is of children who need dental care using local anesthesia. Study participant's behavioral reactions and heart rate during injection of local anesthetic with and without having a therapy dog present will be recorded and children and their guardians will be asked a few short questions about the injection and therapy dog after injection.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Children undergoing dental restorative or surgical procedures require injection of local anesthetic. The injection procedure is often the most anxiety-producing stimulus for children during dental care, when children demonstrate the highest level of emotional distress. Several studies have investigated various interventions, such as distraction, hypnosis, and cognitive behavioral therapy to ease this stress. Animal-assisted therapy (e.g. the presence of a therapy dog) may be a promising strategy for managing anxiety in young dental patients. However, no studies have explored the potential benefits of using therapy dogs specifically during the administration of local anesthesia in pediatric dental patients. The objective of this randomized controlled trial is to investigate the effects of therapy dogs on pediatric dental patients during local anesthesia administration.

Studietype

Ingrijpend

Inschrijving (Geschat)

25

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Michigan
      • Ann Arbor, Michigan, Verenigde Staten, 48109
        • Werving
        • University of Michigan School of Dentistry Children's Clinic
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

4 jaar tot 12 jaar (Kind)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

Inclusion Criteria:

  • Age range: children aged 4- to 12-years
  • Health status: healthy children without significant medical conditions (ASA I or ASA II)
  • Dental procedure: children scheduled for at least two dental procedures requiring local anesthesia
  • Consent: written informed consent from the parent or legal guardian
  • Verbal assent from potential subjects age 4-9 years; written assent for children age 10-12 years

Exclusion Criteria:

  • Allergies: children with known allergies to dogs or animal dander
  • Children with a fear or phobia of dogs
  • Children with a behavioral disorder which may negatively impact response to the presence of a therapy dog
  • Previous exposure: children who have previously undergone dental procedures with local anesthesia in the presence of a therapy dog
  • Medical conditions: children with medical conditions that might affect their vital signs independently of the dental procedure (e.g., heart conditions)
  • Parental discomfort: cases where parents are uncomfortable with the presence of a therapy dog during the procedure
  • Advanced behavior guidance is indicated: children whose behavior for dental examination is classified as "Definitely Negative" (Frankl 1)

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Crossover-opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Control

Standard-of-care basic behavior guidance during local anesthesia
Gedragsmatig: Standard-of-care basic behavior guidance

Basic behavior guidance as defined by the American Academy of Pediatric Dentistry includes strategies to help children cope through potentially stressful dental procedures. These strategies include tell-show-do, positive reinforcement, parental presence, and nitrous oxide/oxygen analgesia, among others.
Experimenteel: Therapy dog presence

Therapy dog present during local anesthesia administration
Gedragsmatig: Therapy dog presence

A trained therapy dog will be present during the child's dental appointment. The dog will be in the operatory as the child enters the room and will lie on the child during injection of local anesthesia.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
Tijdsspanne: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia

The subject's behavior from entry into the operatory through one minute following administration of local anesthesia will be evaluated and recorded using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, with each category scored from 0 to 2. The higher the total score, which ranges from 0 to 10, indicates more distress.
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Heart rate
Tijdsspanne: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia

The subject's heart rate will be monitored and recorded every 30 seconds from entry into the operatory through one minute following administration of local anesthesia.
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)
Tijdsspanne: Upon entering the operatory and after administration of local anesthesia

The subject will be asked to complete an anxiety assessment using the revised modified faces version of the modified child dental anxiety scale (MCDASF). This questionnaire has two questions which are each answered on a five-point scale (range 1-5 for each question for a total range of 2-10). Higher values represent more distress.
Upon entering the operatory and after administration of local anesthesia
Parent questionnaire
Tijdsspanne: Following injection of local anesthetic

The subject's parent will be asked four questions regarding their child's anxiety and the therapy dog (if present). These four questions are not scaled. The questions are: Do you think your child was anxious for local anesthesia? Y/N; Do you think the therapy dog reduced your child's dental anxiety during local anesthesia? Yes/No; Would you want a therapy dog present for future dental treatment appointments? Yes/No; How do you think your child fees post-local anesthesia? Very Anxious/Anxious/Neutral/Calm/Very Calm.
Following injection of local anesthetic

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Michigan

Onderzoekers

  • Hoofdonderzoeker: James R. Boynton, DDS, MS, University of Michigan

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 november 2024

Primaire voltooiing (Geschat)

10 november 2026

Studie voltooiing (Geschat)

1 juli 2027

Studieregistratiedata

Eerst ingediend

5 december 2024

Eerst ingediend dat voldeed aan de QC-criteria

5 december 2024

Eerst geplaatst (Werkelijk)

10 december 2024

Updates van studierecords

Laatste update geplaatst (Werkelijk)

10 november 2026

Laatste update ingediend die voldeed aan QC-criteria

7 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • HUM00260476

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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