- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03324347
Dog-Assisted Therapy in Dentistry
Dog-Assisted Therapy in Dental Care Settings
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Tromsø, Norway, N-9037
- Department of Clinical Dentistry, UiT The Arctic University of Norway
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: SINGLE
Arms and Interventions
Participant Group / 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.
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Presence of a therapydog during a clinical examination in a dental clinic
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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up to 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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up to 8 weeks
|
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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.
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up to 8 weeks
|
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Salivary cortisol level
Time Frame: up to 8 weeks
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Measurement of cortisol from participant's saliva sample to assess if dog-assisted therapy (DAT) minimizes stress and anxiety
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up to 8 weeks
|
|
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)
|
up to 8 weeks
|
|
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)
|
up to 8 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne M Gussgard, DDS,MSc,PhD, Department of Clinical Dentistry, UiT The Arctic University of Norway
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2017/1078 (REK)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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