Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorUniversity of Michigan
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
Therapy dog presence
BehavioralA 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.
Standard-of-care basic behavior guidance
BehavioralBasic 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.
Treatment groups
25 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: Therapy dog presenceExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
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.
Time frame
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesiaSecondary outcomes
1
Heart rate
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.
Time frame
Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia2
Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)
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.
Time frame
Upon entering the operatory and after administration of local anesthesia3
Parent questionnaire
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.
Time frame
Following injection of local anestheticSponsors and contacts
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Source ClinicalTrials.gov