Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
Situational Anxiety · Behavior
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- 4 years - 12 years
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 25 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Read the full description
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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)
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- No masking
Control
Standard-of-care basic behavior guidance during local anesthesia
Behavioral: Standard-of-care basic behavior guidance
Therapy dog presence
Therapy dog present during local anesthesia administration
Behavioral: Therapy dog presence
Therapy dog presence BEHAVIORAL
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.
Standard-of-care basic behavior guidance BEHAVIORAL
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.
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Behavior (Face, Legs, Activity, Cry, and Consolability scale)
Time frame: 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.
Secondary measures
Heart rate
Time frame: 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.
Anxiety assessment (Modified Faces version of the Modified Child Dental Anxiety scale)
Time frame: 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.
Parent questionnaire
Time frame: 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.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
University of Michigan School of Dentistry Children's ClinicAnn Arbor, Michigan, United StatesRecruiting
Study team and timeline
- Lead sponsor
- University of Michigan
- Study start
- Nov 1, 2024 Actual
- Primary completion
- Nov 10, 2026 Estimated
- Study completion
- 2027-07 Estimated
- First posted
- Dec 10, 2024 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
Official study title
Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026