- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01226017
A Possible Effect of Oxytocin During Interaction Between Humans and Animals (Oxytocin2010)
November 22, 2011 updated by: Gunn Pedersen, Norwegian University of Life Sciences
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals and filling in instruments measuring anxiety and stress.
Study Type
Interventional
Enrollment (Actual)
18
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
-
-
-
Aas, Norway, 1432
- Norwegian University of Life Sciences
-
-
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
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- woman
- age 20-30 years old
- physical capable of being in a farm environment and have contact with cows
Exclusion Criteria:
- pregnancy
- breastfeeding
- anxiety for blood sampling
- anxiety for animals
- allergies
- psychiatric diagnoses
- medication
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: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the possible change in Oxytocin level in human blood during intervention with farm animals.
Time Frame: Start medio October 2010, and end December 2011 (14 months)
|
Blood sampling will be drawn at baseline, before intervention starts, and 5 minutes after start.
3rd sample will be drawn 15 minutes after start.
Total time of intervention is 15 minutes.
|
Start medio October 2010, and end December 2011 (14 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self evaluation of anxiety and coping strategies.
Time Frame: Start medio October 2010, and end December 2011 (14 months)
|
Spielberger State Anxiety Inventory (SSAI) (Spielberger et al, 1979)and Coping Strategies Scale of the Pressure Management Indicator (Williams & Cooper, 1998.
|
Start medio October 2010, and end December 2011 (14 months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bente Berget, PhD, Norwegian University of Life Sciences
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
October 1, 2010
Primary Completion (Actual)
November 1, 2011
Study Completion (Actual)
November 1, 2011
Study Registration Dates
First Submitted
October 20, 2010
First Submitted That Met QC Criteria
October 20, 2010
First Posted (Estimate)
October 21, 2010
Study Record Updates
Last Update Posted (Estimate)
November 23, 2011
Last Update Submitted That Met QC Criteria
November 22, 2011
Last Verified
November 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010/1589
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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