NCT03324347

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2017

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 27, 2017

Completed
4 days until next milestone

Study Start

First participant enrolled

October 31, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2019

Completed
Last Updated

July 31, 2019

Status Verified

October 1, 2018

Enrollment Period

1.6 years

First QC Date

October 11, 2017

Last Update Submit

July 30, 2019

Conditions

Keywords

Animal-Assisted InterventionDog-Assisted InterventionDental CareQuestionnairePilot ProjectDental Clinic

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Child satisfaction

    up to 8 weeks

  • Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule)

    up to 8 weeks

  • Salivary cortisol level

    up to 8 weeks

  • Heart rate variability

    up to 8 weeks

  • Skin conductance (Electrodermal activity)

    up to 8 weeks

Study Arms (2)

Therapydog

EXPERIMENTAL

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

No therapydog

NO INTERVENTION

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

Interventions

TherapydogPROCEDURE

Presence of a therapydog during a clinical examination in a dental clinic

Therapydog

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Clinical Dentistry, UiT The Arctic University of Norway

Tromsø, N-9037, Norway

Location

Study Officials

  • Anne M Gussgard, DDS,MSc,PhD

    Department of Clinical Dentistry, UiT The Arctic University of Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2017

First Posted

October 27, 2017

Study Start

October 31, 2017

Primary Completion

June 5, 2019

Study Completion

June 5, 2019

Last Updated

July 31, 2019

Record last verified: 2018-10

Locations