Dental AnxietyNCT03324347
Dog-Assisted Therapy in Dentistry
A study testing Therapydog in people with Dental Anxiety and Pediatric Dentistry, run by University of Tromso at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Dental Anxiety, Pediatric Dentistry, Animal Assisted Therapy
- What is being tested?
- Therapydog
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteNorway
- Study dates
- 31 Oct 2017to 5 Jun 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Clinical Dentistry, UiT The Arctic University of Norway
Tromsø, N-9037
About this study
Official title: 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.
- Conditions
- Dental Anxiety, Pediatric Dentistry, Animal Assisted Therapy
- Being tested
- Therapydog
- Keywords
- Animal-Assisted Intervention, Dog-Assisted Intervention, Dental Care, Questionnaire, Pilot Project, Dental Clinic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapydogProcedure or surgery
Presence of a therapydog during a clinical examination in a dental clinic
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Examination achieved; Yes or No
Whether the child complied or not, so that a clinical oral examination could be accomplished within 30 minutes
Measured: up to 8 weeks
Secondary outcomes (5)
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.
Measured: up to 8 weeks
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.
Measured: up to 8 weeks
Salivary cortisol level
Measurement of cortisol from participant's saliva sample to assess if dog-assisted therapy (DAT) minimizes stress and anxiety
Measured: up to 8 weeks
Heart rate variability
Heart rate will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software)
Measured: up to 8 weeks
Skin conductance (Electrodermal activity)
Skin conductance will be measured to assess if dog-assisted therapy (DAT) minimizes stress and anxiety. (Biopac Systems software)
Measured: up to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start31 Oct 2017
- Primary completion5 Jun 2019
- Study completion5 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Tromso
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne M Gussgard, DDS,MSc,PhD, Principal investigator, Department of Clinical Dentistry, UiT The Arctic University of Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324347
- Sponsor's protocol ID
- 2017/1078 (REK)
- Status last verified
- Oct 2018
- First submitted
- 11 Oct 2017
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dog-Assisted Therapy in Dental Care Settings
- ClinicalTrials.gov ID
- NCT03324347
- Acronym / sponsor ID
- 2017/1078 (REK)
- Conditions
- Dental Anxiety, Pediatric Dentistry, Animal Assisted Therapy
- Keywords
- Animal-Assisted Intervention, Dog-Assisted Intervention, Dental Care, Questionnaire, Pilot Project, Dental Clinic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of TromsoUniversity, hospital or other
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 5 Jun 2019 (actual)
- Study completion
- 5 Jun 2019 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapydog | Experimental | Procedure: TherapydogA 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. |
| 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. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TherapydogPresence of a therapydog during a clinical examination in a dental clinic | Procedure or surgery | Therapydog |
Primary outcome
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
5 secondary outcomes
Child satisfaction
Time frame: up to 8 weeks
Measurement of anxiety through the CFSS-DS scale (Dental subscale of Children's Fear Survey Schedule)
Time frame: up to 8 weeks
Salivary cortisol level
Time frame: up to 8 weeks
Heart rate variability
Time frame: up to 8 weeks
Skin conductance (Electrodermal activity)
Time frame: up to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne M Gussgard, DDS,MSc,PhD principal investigator
Department of Clinical Dentistry, UiT The Arctic University of Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapydog in people with Dental Anxiety and Pediatric Dentistry, run by University of Tromso at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Examination achieved; Yes or No (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2019.