- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03852264
Oxytocin Pathways and the Health Effects of Human-Animal Interaction
November 4, 2022 updated by: University of Arizona
This study investigates the roles of oxytocin and vasopressin in human-animal interaction.
Children will participate in three conditions involving friendly interactions with dogs, or play with toys at a university laboratory.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Oxytocin (OT) and arginine vasopressin (AVP) are neuropeptides that play critical roles in social behavior, cognition, stress physiology, and physical health.
OT is released in adult humans and dogs during affiliative forms of human-animal interaction (HAI), and HAI attenuates AVP release in dogs.
Thus, HAI may provide a safe and effective approach for stimulating endogenous OT release, and inhibiting endogenous AVP activity.
The investigators will recruit a sample of typically developing 8-10 year old children who will engage in structured HAI sessions with a familiar companion dog or unfamiliar dog, compared to a nonsocial control condition.
Study Type
Interventional
Enrollment (Actual)
30
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
-
-
Arizona
-
Tucson, Arizona, United States, 85721
- University of Arizona
-
-
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
8 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants in this study will include typically-developing children between 8-10 years. Enrollment will be limited to individuals who self-identify as white and not Hispanic or Latino for reasons related to the epigenetic analyses
Exclusion Criteria:
- known medical diseases or injuries involving the central nervous or endocrine systems, major physical abnormalities, seizures, and significant sensory, cognitive, or motor impairments
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: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Concentration of salivary oxytocin (pg/mL)
Time Frame: 15 minutes
|
Concentration of salivary oxytocin measured by immunoassay (pg/mL)
|
15 minutes
|
Concentration of salivary vasopressin (pg/mL)
Time Frame: 15 minutes
|
Concentration of salivary vasopressin measured by immunoassay (pg/mL)
|
15 minutes
|
Concentration of urinary oxytocin (pg/mL)
Time Frame: 50 minutes
|
Concentration of urinary oxytocin measured by immunoassay (pg/mL)
|
50 minutes
|
Concentration of urinary vasopressin (pg/mL)
Time Frame: 50 minutes
|
Concentration of urinary vasopressin measured by immunoassay (pg/mL)
|
50 minutes
|
Concentration of salivary cortisol (ug/dL)
Time Frame: 50 minutes
|
Concentration of salivary cortisol measured by immunoassay (ug/dL)
|
50 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Principal component score reflecting positive affect
Time Frame: 30 minutes
|
Principal component score from frequency and duration of positive affect indicators (smiling, laughing) coded by ethogram.
Frequency and duration of smiling and laughing will be combined to report positive affect in an aggregate principal component score.
|
30 minutes
|
Principal component score reflecting affiliative social behavior
Time Frame: 30 minutes
|
Principal component score from frequency and duration of affiliative behaviors (physical contact, eye gaze, dog-directed speech) coded by ethogram.
Frequency and duration of physical contact, eye gaze, and dog-directed speech will be combined to report affiliative behavior in an aggregate principal component score.
|
30 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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)
March 8, 2019
Primary Completion (Actual)
January 10, 2022
Study Completion (Actual)
January 10, 2022
Study Registration Dates
First Submitted
February 19, 2019
First Submitted That Met QC Criteria
February 21, 2019
First Posted (Actual)
February 25, 2019
Study Record Updates
Last Update Posted (Actual)
November 8, 2022
Last Update Submitted That Met QC Criteria
November 4, 2022
Last Verified
September 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 1808883345
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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