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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03324347
Other study ID # 2017/1078 (REK)
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 31, 2017
Est. completion date June 5, 2019

Study information

Verified date October 2018
Source University of Tromso
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 5, 2019
Est. primary completion date June 5, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years to 12 Years
Eligibility 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

Study Design


Intervention

Procedure:
Therapydog
Presence of a therapydog during a clinical examination in a dental clinic

Locations

Country Name City State
Norway Department of Clinical Dentistry, UiT The Arctic University of Norway Tromsø

Sponsors (1)

Lead Sponsor Collaborator
University of Tromso

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary Examination achieved; Yes or No Whether the child complied or not, so that a clinical oral examination could be accomplished within 30 minutes up to 8 weeks
Secondary Child satisfaction 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. up to 8 weeks
Secondary Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule) 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. up to 8 weeks
Secondary Salivary cortisol level Measurement of cortisol from participant's saliva sample to assess if dog-assisted therapy (DAT) minimizes stress and anxiety up to 8 weeks
Secondary Heart rate variability Heart rate will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software) up to 8 weeks
Secondary Skin conductance (Electrodermal activity) Skin conductance will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software) up to 8 weeks
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