Situational AnxietyNCT06725134
Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures
A study testing Therapy dog presence and Standard-of-care basic behavior guidance in people with Situational Anxiety and Behavior, run by University of Michigan at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Situational Anxiety, Behavior
- What is being tested?
- Therapy dog presence and Standard-of-care basic behavior guidance
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2024to Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan School of Dentistry Children's Clinic
Ann Arbor, Michigan, 48109
James R Boynton, DDS, MS, 734-764-1523, jboynton@umich.edu
About this study
Official title: Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled 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.
Read the detailed 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.
- Conditions
- Situational Anxiety, Behavior
- Being tested
- Therapy dog presence, Standard-of-care basic behavior guidance
- Keywords
- Animal assisted therapy, Pediatric dentistry, Local anesthesia
- Medical subject headings
- Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy dog presenceBehavioural
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 guidanceBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Standard-of-care basic behavior guidance during local anesthesia Receives: Behavioral: Standard-of-care basic behavior guidance |
| Therapy dog presence | Experimental | Therapy dog present during local anesthesia administration Receives: Behavioral: Therapy dog presence |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Every 30 seconds from entry into the operatory through one-minute following injection of local anesthesia
Secondary outcomes (3)
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.
Measured: 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)
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.
Measured: Upon entering the operatory and after administration of local anesthesia
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.
Measured: Following injection of local anesthetic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Nov 2024
- Primary completionNov 2026 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Situational AnxietyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James R. Boynton, University of Michigan
- Investigators
- James R. Boynton, DDS, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725134
- Sponsor's protocol ID
- HUM00260476
- Status last verified
- Nov 2025
- First submitted
- 5 Dec 2024
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06725134
- Acronym / sponsor ID
- HUM00260476
- Conditions
- Situational Anxiety, Behavior
- Keywords
- Animal assisted therapy, Pediatric dentistry, Local anesthesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Standard-of-care basic behavior guidanceStandard-of-care basic behavior guidance during local anesthesia |
| Therapy dog presence | Experimental | Behavioral: Therapy dog presenceTherapy dog present during local anesthesia administration |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapy dog presenceA 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. | Behavioural | Therapy dog presence |
| Standard-of-care basic behavior guidanceBasic 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. | Behavioural | Control |
Primary outcome
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.
3 secondary outcomes
Heart rate
Time frame: 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)
Time frame: Upon entering the operatory and after administration of local anesthesia
Parent questionnaire
Time frame: Following injection of local anesthetic
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James R. Boynton, DDS, MS principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapy dog presence and Standard-of-care basic behavior guidance in people with Situational Anxiety and Behavior, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James R Boynton, DDS, MS (734-764-1523, jboynton@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.