Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06725134

Impact of Therapy Dogs on Child Anxiety and Behavior During Local Anesthesia for Dental Procedures

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Situational Anxiety Behavior

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Michigan School of Dentistry Children's Clinic

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

James R Boynton, DDS, MS

CONTACT

[email protected]

734-764-1523

About this study

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 can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

James R Boynton, DDS, MS

CONTACT

[email protected]

734-764-1523

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Impact of Therapy Dogs on Anxiety and Behavior of Pediatric Dental Patients During Local Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 10, 2024
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.