Therapy AnimalsNCT06057090
Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?
A study testing Therapy Dog in people with Therapy Animals and Dental Anxiety, run by Medical University of South Carolina at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients. Read more about this study
- Who is it for?
- Ages 3 to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Therapy Animals, Dental Anxiety, Child Behavior
- What is being tested?
- Therapy Dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Sep 2023to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 3 to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 3-7
- Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
- Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
- Children whose parents/guardians are willing to consent to the child participating in the study
- Availability of parent to be present during treatment
- Children who require further care that includes the injection of a local anesthetic and whose procedure will take less than one hour
Who cannot join
- Patients whose cases are considered emergencies
- Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
- If patient's medical status has worsened since initial evaluation
- Known allergy to dogs or other animals
- Past history of dental trauma
- Past history of animal bites or traumatic experience with a dog
- Emotional or developmental delays
- If, on the day of the treatment, patient presents with fever or other illness
Trial locations and contacts
1 site in 1 country.
United States1 site
Medical University of South Carolina Pediatric Dental Clinic
Charleston, South Carolina, 29425
About this study
Official title: Do Certified Therapy Dogs Improve Behavior and Reduce Anxiety in Children Who Receive Administration of a Local Anesthetic for Dental Procedures? A Randomized Controlled Trial
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.
The main questions it aims to answer are:
Read more
- Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
- How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
- Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?
All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.
- Conditions
- Therapy Animals, Dental Anxiety, Child Behavior, Anesthesia, Local
- Being tested
- Therapy Dog
- Medical subject headings
- Child Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy DogBehavioural
Certified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients.
| Study group | Role | What they receive |
|---|---|---|
| Therapy Dog | Experimental | This group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure. Receives: Behavioral: Therapy Dog |
| Control | No intervention | The control group receives standard of care and does not have a therapy dog present in the room during their treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measure, using the Frankl score
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
Measured: This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Secondary outcomes (4)
Parent survey responses
Parents will be given a short survey about their child's participation in the study. Each arm of the study has its own survey. The survey for the control group is 4 multiple choice questions and one open-ended question. The survey for the experimental group contains 3 multiple choice questions and 1 open-ended question.
Measured: The surveys will be administered immediately after the procedure.
Microbial concentration
In the experimental arm, the dental operatory will be swabbed prior to the arrival of the therapy dog and again after the therapy dog as left. For the control group, the operatory will be swabbed.
Measured: Experimental group: prior to arrival of therapy dog, and after departure of therapy dog. Control group: prior to arrival of participant, after departure of participant
Anxiety measure, heart rate
The participant's heart rate will be recorded, using a finger pulse oximeter
Measured: The heart rate will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Anxiety measure, oxygen saturation
The participant's oxygen saturation will be recorded, using a finger pulse oximeter
Measured: Oxygen saturation will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2023
- Study start13 Sep 2023
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Why it stopped: We could not recruit enough participants.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Therapy AnimalsStudies of the same condition, open and under way.
- More trials run by Medical University of South CarolinaThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of South Carolina
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie L Marshall, PhD, Principal investigator, James B. Edwards College of Dental Medicine, Medical University of South Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06057090
- Sponsor's protocol ID
- Pro00129098
- Status last verified
- Apr 2026
- First submitted
- 9 Aug 2023
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paryab M, Arab Z. The effect of Filmed modeling on the anxious and cooperative behavior of 4-6 years old children during dental treatment: A randomized clinical trial study. Dent Res J (Isfahan). 2014 Jul;11(4):502-7. doi: 10.4103/1735-3327.139426.
PubMed 25225565Vincent A, Easton S, Sterman J, Farkas K, Heima M. Acceptability and Demand of Therapy Dog Support Among Oral Health Care Providers and Caregivers of Pediatric Patients. Pediatr Dent. 2020 Jan 15;42(1):16-21.
PubMed 32075705Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.
PubMed 24731910Casamassimo PS, Seale NS, Rutkauskas Ii JS, Rutkauskas JS. Are U.S. Dentists Adequately Trained to Care for Children? Pediatr Dent. 2018 Mar 15;40(2):93-97.
PubMed 29663907Stern J, Agarwal A, Pozun A. Pediatric Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/
PubMed 34283466Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
PubMed 20332509
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Do Certified Therapy Dogs Improve Behavior and Reduce Anxiety in Children Who Receive Administration of a Local Anesthetic for Dental Procedures? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06057090
- Acronym / sponsor ID
- Pro00129098
- Conditions
- Therapy Animals, Dental Anxiety, Child Behavior, Anesthesia, Local
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: We could not recruit enough participants.
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of South CarolinaUniversity, hospital or other
- Study start
- 13 Sep 2023 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 28 Sep 2023 (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.
The goal of this clinical trial is to assess whether the presence of a certified therapy dog during dental procedures that require an injection reduces anxiety and improves behavior in pediatric dental patients.
The main questions it aims to answer are:
- Does the presence of a certified therapy dog during dental procedure requiring an injection reduce anxiety and improve behavior in pediatric dental patients?
- How do the parents of pediatric dental patients who participate in the study view the use of a certified therapy dog in their child's treatment?
- Does the presence of a certified therapy dog result in different concentrations of microbes in the treatment room?
All participants will receive standard of care. Researchers will compare the group with a therapy dog present to a group who does not have a therapy dog present to see if heart rate, oxygen saturation, percentage of nitrous oxide administered, and Frankl scores differ between the groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy Dog | Experimental | Behavioral: Therapy DogThis group will have a certified therapy dog present in the treatment room throughout the procedure. Prior to the procedure, the participant will be briefly introduced to the therapy dog and handler, who will remain in the room until the end of the procedure. |
| Control | No intervention | –The control group receives standard of care and does not have a therapy dog present in the room during their treatment. |
Who may qualify
- Ages
- 3 to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Age 3-7
- Children who are patients at the Medical University of South Carolina Department of Pediatric Dentistry
- Children classified as category 1 or 2 according to the American Society of Anesthesiologists Physical Status Classification
- Children whose parents/guardians are willing to consent to the child participating in the study
- Availability of parent to be present during treatment
Key exclusion criteria (8 listed)
- Patients whose cases are considered emergencies
- Patients who are classified as category 3 or higher according to the American Society of Anesthesiologists Physical Status Classification (6)
- If patient's medical status has worsened since initial evaluation
- Known allergy to dogs or other animals
- Past history of dental trauma
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 DogCertified, volunteer therapy dogs and their handlers will be present in the room during procedures in the experimental arm to see if their presence reduces anxiety and improves behavior in pediatric dental patients. | Behavioural | Therapy Dog |
Primary outcome
Behavioral measure, using the Frankl score
Time frame: This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)
4 secondary outcomes
Parent survey responses
Time frame: The surveys will be administered immediately after the procedure.
Microbial concentration
Time frame: Experimental group: prior to arrival of therapy dog, and after departure of therapy dog. Control group: prior to arrival of participant, after departure of participant
Anxiety measure, heart rate
Time frame: The heart rate will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Anxiety measure, oxygen saturation
Time frame: Oxygen saturation will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure
Results and safety
The study was stopped early (reason given: We could not recruit enough participants.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
- Background: PubMed 25225565Paryab M, Arab Z. The effect of Filmed modeling on the anxious and cooperative behavior of 4-6 years old children during dental treatment: A randomized clinical trial study. Dent Res J (Isfahan). 2014 Jul;11(4):502-7. doi: 10.4103/1735-3327.139426.
- Background: PubMed 32075705Vincent A, Easton S, Sterman J, Farkas K, Heima M. Acceptability and Demand of Therapy Dog Support Among Oral Health Care Providers and Caregivers of Pediatric Patients. Pediatr Dent. 2020 Jan 15;42(1):16-21.
- Background: PubMed 24731910Kamioka H, Okada S, Tsutani K, Park H, Okuizumi H, Handa S, Oshio T, Park SJ, Kitayuguchi J, Abe T, Honda T, Mutoh Y. Effectiveness of animal-assisted therapy: A systematic review of randomized controlled trials. Complement Ther Med. 2014 Apr;22(2):371-90. doi: 10.1016/j.ctim.2013.12.016. Epub 2014 Jan 6.
- Background: PubMed 29663907Casamassimo PS, Seale NS, Rutkauskas Ii JS, Rutkauskas JS. Are U.S. Dentists Adequately Trained to Care for Children? Pediatr Dent. 2018 Mar 15;40(2):93-97.
- Background: PubMed 34283466Stern J, Agarwal A, Pozun A. Pediatric Procedural Sedation. 2025 Mar 22. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK572100/
- Background: PubMed 20332509Schulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010 Mar 23;340:c332. doi: 10.1136/bmj.c332.
- 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. This study is not recruiting at the moment.
Julie L Marshall, PhD principal investigator
James B. Edwards College of Dental Medicine, Medical University of South Carolina
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 in people with Therapy Animals and Dental Anxiety, run by Medical University of South Carolina 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 4 May 2026. 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?
The study was stopped early (reason given: We could not recruit enough participants.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Behavioral measure, using the Frankl score (time frame: This behavior measure will be recorded at four timepoints: 1) immediately before the procedure, 2) during the procedure 3) during the procedure, and 4) immediately after the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06057090, which also lists 6 linked publications.
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 4 May 2026.