Anxiety Clinical Trial
— AATOfficial title:
Animal Assisted Therapy's Effects on Young Dental Patients
NCT number | NCT05464888 |
Other study ID # | 22-1454 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | February 2, 2023 |
Est. completion date | February 2027 |
A prospective randomized trial measuring physiologic biometrics and perceptions of stress during a pediatric dental exam, cleaning, and simulated radiographs with or without a therapy dog present.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | February 2027 |
Est. primary completion date | February 2027 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 4 Years to 8 Years |
Eligibility | Inclusion Criteria: Subjects must meet all of the following inclusion criteria to be eligible for enrollment in the study: - 4-8 years of age - English speaking - Qualifies for a dental exam and prophylaxis (cleaning) by having not received a dental prophylaxis or oral exam in the past 3 months - Stable physical health, decided at the discretion of the study coordinator and PI - Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based on research site personnel's assessment - Evidence of a personally signed and dated informed assent form from the child and legal guardian's consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial and all of their questions have been answered Exclusion Criteria: Subjects presenting with any of the following will not be included in the study: - Patients <4yo and >8yo - Non-English speakers - Patients unwilling to assent/participate or parental/guardian consent was not given - Self-report or parental report of patient suffering current dental pain - Known allergies or significant adverse reactions following exposure to dogs or the use of oral hygiene products (toothpastes, mouth rinses), and all ingredients in prophy paste - Children who are afraid of dogs or had a prior negative experience with dogs as reported by the parent or child - Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this trial - Developmental/cognitive disability such that patient cannot self-assent, comprehend and follow the requirements of the study based on research site personnel's assessment |
Country | Name | City | State |
---|---|---|---|
United States | General & Oral Health Center | Chapel Hill | North Carolina |
Lead Sponsor | Collaborator |
---|---|
University of North Carolina, Chapel Hill |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Heart Rate during Dental Exam | Beats per minute during dental exam. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental exam, approximately 2- 5 minutes. | |
Primary | Mean Heart Rate during Dental Cleaning | Beats per minute during dental cleaning. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental cleaning, approximately 2- 5 minutes. | |
Primary | Mean Heart Rate during Dental Radiograph Simulation | Beats per minute during dental radiograph simulation. Heart rate measured using wrist-worn Shimmer heart rate tracking device. | During dental radiograph simulation, approximately 2- 5 minutes. | |
Primary | Salivary Cortisol during Dental Exam | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental exam, approximately 1-2 minutes. | |
Primary | Salivary Cortisol during Dental Cleaning | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental cleaning, approximately 1-2 minutes. | |
Primary | Salivary Cortisol during Dental Radiograph Simulation | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental radiograph simulation, approximately 1-2 minutes. | |
Primary | Salivary Amylase during Dental Exam | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental exam, approximately 1-2 minutes. | |
Primary | Salivary Amylase during Dental Cleaning | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental cleaning, approximately 1-2 minutes. | |
Primary | Salivary Amylase during Dental Radiograph Simulation | To measure stress levels salivette swab will be placed in child's cheek to absorb saliva. Swabs are spun down for extraction and saliva sample will undergo ELISA assay to measure cortisol level. | During dental radiograph simulation, approximately 1-2 minutes. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT05777044 -
The Effect of Hatha Yoga on Mental Health
|
N/A | |
Recruiting |
NCT04680611 -
Severe Asthma, MepolizumaB and Affect: SAMBA Study
|
||
Completed |
NCT04512768 -
Treating Comorbid Insomnia in Transdiagnostic Internet-Delivered Cognitive Behaviour Therapy
|
N/A | |
Completed |
NCT04748367 -
Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care
|
N/A | |
Recruiting |
NCT05563805 -
Exploring Virtual Reality Adventure Training Exergaming
|
N/A | |
Completed |
NCT04579354 -
Virtual Reality (VR) Tour to Reduce Preoperative Anxiety Before Anaesthesia
|
N/A | |
Completed |
NCT03457714 -
Guided Internet Delivered Cognitive-Behaviour Therapy for Persons With Spinal Cord Injury: A Feasibility Trial
|
||
Completed |
NCT03535805 -
Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances
|
N/A | |
Recruiting |
NCT05956912 -
Implementing Group Metacognitive Therapy in Cardiac Rehabilitation Services (PATHWAY-Beacons)
|
||
Active, not recruiting |
NCT05302167 -
Molehill Mountain Feasibility Study.
|
N/A | |
Completed |
NCT05881681 -
A Mindfulness Approach to UA for Afro-descendants
|
N/A | |
Completed |
NCT05588622 -
Meru Health Program for Cancer Patients With Depression and Anxiety
|
N/A | |
Active, not recruiting |
NCT04961112 -
Evaluating the Efficacy of Cranial Electrotherapy Stimulation in Mitigating Anxiety-induced Cognitive Deficits
|
N/A | |
Terminated |
NCT04612491 -
Pre-operative Consultation on Patient Anxiety and First-time Mohs Micrographic Surgery
|
||
Completed |
NCT05980845 -
The Effect Nature Sounds and Music on Hemodialysis Patients
|
N/A | |
Recruiting |
NCT05449002 -
Digital Single Session Intervention for Youth Mental Health
|
N/A | |
Completed |
NCT05585749 -
Virtual Reality Application on Pain Intensity and Anxiety Level in Endoscopy Patients
|
N/A | |
Terminated |
NCT03272555 -
WILD 5 Wellness: A 30-Day Intervention
|
N/A | |
Recruiting |
NCT05997849 -
Development of a Multiplatform Mental Health Mobile Tool
|
N/A | |
Completed |
NCT06421233 -
The Effect of Endorphin Massage Applied to Postpartum Women on Anxiety and Fatigue Levels
|
N/A |