- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06713928
Effectiveness of Dog-Assisted Therapy on Compliance and Home Oral Hygiene Activities in Disabled Patients
February 19, 2025 updated by: Jacopo Lanzetti, University of Turin, Italy
Recent scientific studies have shown how interaction with an animal can alleviate particular conditions of stress and conflict, thus representing a solid support for minor patients with social behavior problems or with physical or mental disabilities.
In this co-therapy, a fundamental role is played by the relationship that is established between the human being and the animal, a very particular relationship capable of bringing about positive changes, in both members, but especially in the man who, benefiting from this push for change, can improve his own situation, whatever it is, and follow with greater interest and involvement the actual therapy activities proposed by the team that is following him.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Torino, Italy, 10126
- AOU Città della Salute e della Scienza
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients had to be between 5 and 16 years old;
- Patients with disability;
- Non-collaborating or with limited collaboration (Frankl Scale 1 or 2);
- Patients with a Plaque Control Record (PCR) of 40% or more;
- Patients with partial autonomy in home oral hygiene procedures.
Exclusion Criteria:
- Patients with fear of dogs;
- Patients with dog hair allergy;
- Patients with infectious disease;
- Tetraplegic and visually impaired subjects.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Oral hygiene with dog therapy
use the DAT to support the oral hygiene procedures provided.
|
The DAT session is divided into two phases: a pre-sitting phase in which the patient could interact with the dog, touching, caressing and playing with him, under the supervision of the dog-trainer.
This phase lasted about 15 minutes.
The second phase was a during-sitting phase in which the dog was in the chair, next to the patient, during the entire oral hygiene procedure, under the supervision of the dog-trainer.
|
|
No Intervention: Oral hygiene without dog therapy
make oral hygiene without any type of support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Plaque Control Record (PCR)
Time Frame: 1 month
|
PCR values the presence of dental plaque on the teeth
|
1 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional record
Time Frame: 1 month
|
the patient's perception was recorded using a graphic card that represents the moods of the moment of oral hygiene session
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2024
Primary Completion (Actual)
February 1, 2025
Study Completion (Actual)
February 15, 2025
Study Registration Dates
First Submitted
November 27, 2024
First Submitted That Met QC Criteria
November 27, 2024
First Posted (Actual)
December 3, 2024
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 19, 2025
Last Verified
February 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 0000793
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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