ClinicalTrials.gg
TerminatedNCT06057090Updated May 4, 2026

Do Therapy Dogs Improve Behavior and Reduce Anxiety in Pediatric Dental Patients?

An interventional study of Therapy Dog in Therapy Animals, Dental Anxiety and Child Behavior, sponsored by Medical University of South Carolina. Terminated at 1 site in United States. Open to participants aged 3 Years to 7 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-05-04.

Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Other

Why this study was terminated
We could not recruit enough participants.
Phase
Not applicable
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
3 Years to 7 Years
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Therapy Animals
  • Dental Anxiety
  • Child Behavior
  • Anesthesia, Local

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03

In context

Child Behavior

224 studies on the registry are indexed under Child Behavior; 41 are open to participants now.

This study's enrollment of 41 is below the median of 140 across 197 interventional studies indexed under Child Behavior.

Browse Child Behavior studies →

Lead sponsor

Medical University of South Carolina is the lead sponsor of 874 studies on the registry; 166 are open to participants now.

Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 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

Exclusion criteria

Exclusion Criteria:

  • Patients whose cases are considered emergencies
  • Patients who are classified as category 3 or higher according to the 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

ASA physical status

The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.

05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Therapy Dog

    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.

    Behavioral: Therapy Dog

  • No intervention
    Control

    The control group receives standard of care and does not have a therapy dog present in the room during their treatment.

Interventions

  • BehavioralTherapy Dog

    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.

06

What researchers measure

Primary outcomes

  1. Behavioral measure, using the Frankl score

    Behavior will be recorded using the Frankl score, which ranges from 1 (definitely negative) to 4 (definitely positive)

    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

Secondary outcomes

  1. 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.

    Time frame: The surveys will be administered immediately after the procedure.

  2. 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.

    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

  3. Anxiety measure, heart rate

    The participant's heart rate will be recorded, using a finger pulse oximeter

    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

  4. Anxiety measure, oxygen saturation

    The participant's oxygen saturation will be recorded, using a finger pulse oximeter

    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

07

Study locations

1 site
  • Medical University of South Carolina Pediatric Dental Clinic
    Charleston, South Carolina 29425, United States
08

References and documents

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 25225565 ↗
  • Vincent 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 32075705 ↗
  • Kamioka 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 24731910 ↗
  • Casamassimo 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 29663907 ↗
  • Stern 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 34283466 ↗
  • Schulz 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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06057090
Responsible party
Sponsor
First posted
Sep 28, 2023
Start date
Sep 13, 2023
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026
Last update
May 4, 2026

Study contacts

Julie L Marshall, PhD
principal investigator · James B. Edwards College of Dental Medicine, Medical University of South Carolina

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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