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Dog-Assisted Therapy in Dentistry

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ClinicalTrials.gov Identifier: NCT03324347
Recruitment Status : Recruiting
First Posted : October 27, 2017
Last Update Posted : October 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Tromso

Brief Summary:

Dog-assisted therapy (DAT) is used in several contexts within various areas of health care. One documented effect is that the proximity of a dog may lower anxiety in perceived stressful situations. Many individuals are afraid to visit the dentist, and someone to the extent that they need medication or anesthesia in order to complete their dental treatment. Based on the literature and own empirical observations, the investigators believe that dog-assisted therapy in connection with dental care may have a positive effect on children with dental anxiety or children that avoid dental care. It is desirable to restrict the use of drugs for these patients because of associated risk and side effects.

The purpose of this pilot study is to evaluate whether using a specially trained therapy dog can have a positive effect on children who are afraid in a dental care setting. Eligible participants (n=16) will meet twice at the dental clinic; one treatment session with a therapy dog in the dental clinic and one without. The therapy dog will be accompanied by a certified dog handler. The investigators will measure physiological variations before, during and after the treatment session. The guardian will complete validated questionnaires portraying the participant's experience of previous dental care. The participant and their guardian will also complete validated questionnaires describing their reactions from the two treatment sessions. A descriptive log for each session will be completed by the investigators.


Condition or disease Intervention/treatment Phase
Dental Anxiety Pediatric Dentistry Animal Assisted Therapy Procedure: Therapydog Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dog-Assisted Therapy in Dental Care Settings
Actual Study Start Date : October 31, 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Therapydog
A certified therapydog (together with a certified dog-handler) will be present in the dental clinic while the child will undergo a clinical dental examination by licenced pediatric dentist.
Procedure: Therapydog
Presence of a therapydog during a clinical examination in a dental clinic

No Intervention: No therapydog
No therapydog will be present in the dental clinic while the child will undergo a clinical dental examination by licenced pediatric dentist.



Primary Outcome Measures :
  1. Examination achieved; Yes or No [ Time Frame: up to 8 weeks ]
    Whether the child complied or not, so that a clinical oral examination could be accomplished within 30 minutes


Secondary Outcome Measures :
  1. Child satisfaction [ Time Frame: up to 8 weeks ]
    The child will describe his/her feelings by marking one of 6 different emoticon-style facial expressions where number 1 illustrate the most happy face and number 6 illustrates not happy at all.

  2. Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule) [ Time Frame: up to 8 weeks ]
    The parent/guardian will describe the child's dental fear on a five point scale where 1 is no fear and 5 is the worst fear.

  3. Salivary cortisol level [ Time Frame: up to 8 weeks ]
    Measurement of cortisol from participant's saliva sample to assess if dog-assisted therapy (DAT) minimizes stress and anxiety

  4. Heart rate variability [ Time Frame: up to 8 weeks ]
    Heart rate will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software)

  5. Skin conductance (Electrodermal activity) [ Time Frame: up to 8 weeks ]
    Skin conductance will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software)



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Children who are afraid of visiting the dental office / children who avoid dental treatment,
  • Children who accept the presence of a dog,
  • Parents or guardians who accept the presence of a dog

Exclusion Criteria:

  • Children or parent/guardian that are afraid of dogs,
  • Children or parent/guardian with known dog allergy,
  • Children who are immunocompromised,
  • Children who cannot understand or complete the patient-questionnaire

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03324347


Contacts
Contact: Anne M Gussgard, DDS,MSc,PhD +47 77649150 anne.m.gussgard@uit.no

Locations
Norway
Department of Clinical Dentistry, UiT The Arctic University of Norway Recruiting
Tromsø, Norway, N-9037
Contact: Anne M Gussgard, DDS,MSc,PhD         
Sponsors and Collaborators
University of Tromso
Investigators
Principal Investigator: Anne M Gussgard, DDS,MSc,PhD Department of Clinical Dentistry, UiT The Arctic University of Norway

Responsible Party: University of Tromso
ClinicalTrials.gov Identifier: NCT03324347     History of Changes
Other Study ID Numbers: 2017/1078 (REK)
First Posted: October 27, 2017    Key Record Dates
Last Update Posted: October 31, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Tromso:
Animal-Assisted Intervention
Dog-Assisted Intervention
Dental Care
Questionnaire
Pilot Project
Dental Clinic