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Virkning av terapihunder på barns angst og atferd under lokalbedøvelse for tannprosedyrer

7. november 2026 oppdatert av: James R. Boynton, University of Michigan

Virkning av terapihunder på angst og atferd hos pediatriske tannpasienter under lokalbedøvelse: en randomisert kontrollert prøvelse

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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Intervensjonell

Registrering (Antatt)

25

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • Michigan
      • Ann Arbor, Michigan, Forente stater, 48109
        • Rekruttering
        • University of Michigan School of Dentistry Children's Clinic
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

4 år til 12 år (Barn)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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)

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Control

Standard-of-care basic behavior guidance during local anesthesia
Atferdsmessig: 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.
Eksperimentell: Therapy dog presence

Therapy dog present during local anesthesia administration
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Heart rate
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of Michigan

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. november 2024

Primær fullføring (Antatt)

10. november 2026

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

5. desember 2024

Først innsendt som oppfylte QC-kriteriene

5. desember 2024

Først lagt ut (Faktiske)

10. desember 2024

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

10. november 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

7. november 2026

Sist bekreftet

1. november 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • HUM00260476

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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