Animal Assisted Therapy

NCT07448714 | Completed

• 1 other identifier: 2310153977
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to evaluate whether treatment assisted by companion dogs, as a behavior management technique during dental treatment in pediatric patients, is effective, in children between 4 and 12 years old. The main question it aims to answer is:

1. 1.First visit: without the therapy dog
2. 2.Second visit: with the therapy dog present In both visits, the child will receive the same dental treatment required in their treatment plan.

Conditions

Dental Fear and Anxiety; Animal Assisted Therapy; Dental Treatment

Keywords

Animal Assisted Therapy; behavior management; dental fear and anxiety

Outcome Measures

Primary Outcomes (1)

• Frankl Scale

  Frankl Scale 1. --) Definitely negative. Refusal of treatment, forceful crying, fearfulness, or any other overt evidence of extreme negativism. 2. -) Negative. Reluctance to accept treatment, uncooperative, some evidence of negative attitude but no pronounced (sullen, withdrawn) 3. +) Positive. Acceptance of treatment, cautious behavior at times, willingness to comply with the dentist, at times with reservation, but patient follows the dentist's directions cooperatively. 4. -) Definitely positive. Good rapport with the dentist, interest in the dental procedure, laughter and enjoyment. A Frankl behavior scale (FBR) scale will be recorded during the anesthetic procedure and during the operative/surgical procedure. Two dental visits of 1 hour each will be scheduled to perform dental treatments of similar complexity. One visit without a dog and a second visit with a therapy dog. The Frankl scale will be done by an external evaluator, not the dental operator performing the dental treatment.

  through study completion, an average of 1 year

Study Arms (2)

With a therapy dog

EXPERIMENTAL

The second dental treatment visit, in the presence of a therapy dog. The Frankel scale will be used by an external evaluator not the dental operator performing the dental treatment.

Other: animal assisted therapy

Without a therapy dog

NO INTERVENTION

The first dental treatment visit without the presence of a therapy dog, following general treatment procedure guidelines. The Frankel scale will be used by an external evaluator (not the dental operator) performing the dental treatment.

Interventions

animal assisted therapy OTHER

Presence of a therapy dog during the dental treatment procedure visit

With a therapy dog

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients with ages between 4-12 years old
• Patients who presents history of uncooperativeness during dental treatments and fear/anxiety in the dental setting, according to the parents.
• Patients must have at least two quadrants of dental interventions of similar complexity available

You may not qualify if:

• Children will be excluded if immunocompromised.
• Children with a had a medical history of allergies and/or phobias to dogs.

Sponsors & Collaborators

• University of Puerto Rico: lead

Study Sites (1)

University of Puerto Rico - School of Dental Medicine

San Juan, PR, 00936, Puerto Rico

Location

Related Publications (19)

• Ribeiro CDPV, Alves JB, Kominami PA, Takeshita EM, Bezerra ACB, Massignan C. Does use of animal therapy during dental care help to reduce anxiety in children and adolescents? A systematic review. Int J Paediatr Dent. 2023 Mar;33(2):181-195. doi: 10.1111/ipd.13033. Epub 2022 Nov 10.

  PMID: 36208050 BACKGROUND

• Garrocho-Rangel A, Rosales-Berber M, Rios-Mendez D, Flores-Velazquez J, Trejo-Herbert D, Pozos-Guillen F, Pozos-Guillen A. Dog-Assisted Therapy (DAT) for the management of anxiety during paediatric dental care. A scoping review. Eur J Paediatr Dent. 2024 Jun 3;25(2):120-125. doi: 10.23804/ejpd.2024.2001. Epub 2024 Mar 1.

  PMID: 38501910 BACKGROUND

• Guram JS, Williams DS, Marshall JL. Considerations for Utilizationof Animal-Assisted Therapy in Pediatric Dentistry Practice. J Dent Child (Chic). 2023 May 15;90(2):70-75.

  PMID: 37621045 BACKGROUND

• Prado IM, Carcavalli L, Abreu LG, Serra-Negra JM, Paiva SM, Martins CC. Use of distraction techniques for the management of anxiety and fear in paediatric dental practice: A systematic review of randomized controlled trials. Int J Paediatr Dent. 2019 Sep;29(5):650-668. doi: 10.1111/ipd.12499. Epub 2019 Apr 25.

  PMID: 30908775 BACKGROUND

• Kamatham R, Anchala K, Kanagaluru C, Vinnakota DN. Effectiveness of Animal-Assisted Activity on Pain Perception and Anxiety of Children Undergoing Intraoral Local Anesthetic Administration. J Dent Child (Chic). 2024 Jan 15;91(1):31-37.

  PMID: 38671571 BACKGROUND

• Pinheiro SL, Silva C, Luiz L, Silva N, Fonseca R, Velasquez T, Grandizoli DR. Dog-assisted therapy for control of anxiety in pediatric dentistry. J Clin Pediatr Dent. 2023 Nov;47(6):38-43. doi: 10.22514/jocpd.2023.080. Epub 2023 Nov 3.

  PMID: 37997233 BACKGROUND

• Cruz-Fierro N, Vanegas-Farfano M, Gonzalez-Ramirez MT. Dog-Assisted Therapy and Dental Anxiety: A Pilot Study. Animals (Basel). 2019 Jul 31;9(8):512. doi: 10.3390/ani9080512.

  PMID: 31370328 BACKGROUND

• Khogeer LN, Sabbagh HJ, Felemban OM, Farsi NM. Puppet play therapy in emergency pediatric dental clinic. A randomized clinical trial. BMC Pediatr. 2025 Jul 2;25(1):503. doi: 10.1186/s12887-025-05849-5.

  PMID: 40604606 BACKGROUND

• Gussgard AM, Carlstedt K, Meirik M. Intraoral clinical examinations of pediatric patients with anticipatory anxiety and situational fear facilitated by therapy dog assistance: A pilot RCT. Clin Exp Dent Res. 2023 Feb;9(1):122-133. doi: 10.1002/cre2.679. Epub 2022 Oct 19.

  PMID: 36259429 BACKGROUND

• Massouda J, Ghaltakhchyan N, Judd J, Bocklage C, Selden R, TumSuden O, Nanney E, Lee J, Ginnis J, Strauman T, Sawicki C, Hodges EA, Graves C, Divaris K, Jacox L. Evaluating effects of animal-assisted therapy on pediatric dental care patients: A pilot clinical trial. J Am Dent Assoc. 2025 Jun;156(6):447-457.e14. doi: 10.1016/j.adaj.2025.03.006.

  PMID: 40467121 BACKGROUND

• Kapov G, Linton K, Gatewood C, Liu C, Strauman T, Hodges E, Graves C, Sawicki C, Wu D, Divaris K, Jacox LA. Effects of animal-assisted therapy on dental anxiety, behavior, and perceptions in young pediatric patients: a blinded randomized controlled trial. Trials. 2025 Aug 7;26(1):279. doi: 10.1186/s13063-025-08970-z.

  PMID: 40775655 BACKGROUND

• Sahebalam R, Rafieinezhad R, Boskabad M. Comparison of the Efficacy of Jilo Animation Approach versus Conventional Tell-Show-Do (TSD) Technique on Cooperation and Anxiety Levels of Children during Dental Practice: A Randomized Controlled Clinical Trials. J Dent (Shiraz). 2020 Dec;21(4):284-291. doi: 10.30476/dentjods.2020.81897.1001.

  PMID: 33344678 BACKGROUND

• Odendaal JS. Animal-assisted therapy - magic or medicine? J Psychosom Res. 2000 Oct;49(4):275-80. doi: 10.1016/s0022-3999(00)00183-5.

  PMID: 11119784 BACKGROUND

• American Academy of Pediatric Dentistry. Behavior guidance for the pediatric dental patient. The Reference Manual of Pediatric Dentistry. Chicago, Ill,: American Academy of Pediatric Dentistry; 2022:321-39

  BACKGROUND

• Nammalwar RB, Rangeeth P. A bite out of anxiety: Evaluation of animal-assisted activity on anxiety in children attending a pediatric dental outpatient unit. J Indian Soc Pedod Prev Dent. 2018 Apr-Jun;36(2):181-184. doi: 10.4103/JISPPD.JISPPD_54_18.

  PMID: 29970636 BACKGROUND

• Cajares C, Rutledge C, Haney T. Animal Assisted Therapy in a Special Needs Dental Practice: An Interprofessional Model for Anxiety Reduction. Journal of Intellectual Disability- Diagnosis and Treatment, 2016; 4:25-28.

  BACKGROUND

• Charowski M, Wells MH, Dormois L, Fernandez JA, Scarbecz M, Maclin M. A Randomized Controlled Pilot Study Examining Effects of Animal Assisted Therapy in Children Undergoing Sealant Placement. Pediatr Dent. 2021 Jan 15;43(1):10-16.

  PMID: 33662243 BACKGROUND

• Thakkar TK, Naik SN, Dixit UB. Assessment of dental anxiety in children between 5 and 10 years of age in the presence of a therapy dog: a randomized controlled clinical study. Eur Arch Paediatr Dent. 2021 Jun;22(3):459-467. doi: 10.1007/s40368-020-00583-1. Epub 2020 Nov 27.

  PMID: 33245525 BACKGROUND

• Nalini B, Kumar C. Animal-assisted therapy as a potential tool for management of dental anxiety in children: A questionnaire-based cross-sectional study. Journal of Clinical and Diagnostic Research. 2022;16(2):ZC30-ZC34.

  BACKGROUND

Related Links

• Wong-Baker FACES Foundation. Wong-Baker FACES Pain Rating Scale. Wong-Baker FACES Foundation, 2016.

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Animal Assisted Therapy

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Psychotherapy; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 4, 2026
• Study Start: December 13, 2023
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

PR (1)