Animal Assisted TherapyOxytocin2010NCT01226017
A Possible Effect of Oxytocin During Interaction Between Humans and Animals
A study testing Measuring oxytocin level in blood in people with Animal Assisted Therapy, run by Norwegian University of Life Sciences at 1 site in Norway.
Trial summary
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals. Read more about this study
- Who is it for?
- Ages 20 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Animal Assisted Therapy
- What is being tested?
- Measuring oxytocin level in blood
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2010to Nov 2011
- 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 20 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- woman
- age 20-30 years old
- physical capable of being in a farm environment and have contact with cows
Who cannot join
- pregnancy
- breastfeeding
- anxiety for blood sampling
- anxiety for animals
- allergies
- psychiatric diagnoses
- medication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.
Read the 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.
- Conditions
- Animal Assisted Therapy
- Being tested
- Measuring oxytocin level in blood
- Keywords
- Oxytocin, Animal Assisted therapy, Farm animals, Healthy nursing students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measuring oxytocin level in bloodOther
Also called Oxytocin
Blood sampling and instruments measuring anxiety and stress
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring the possible change in Oxytocin level in human blood during intervention with farm animals.
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.
Measured: Start medio October 2010, and end December 2011 (14 months)
Secondary outcomes (1)
Self evaluation of anxiety and coping strategies.
Spielberger State Anxiety Inventory (SSAI) (Spielberger et al, 1979)and Coping Strategies Scale of the Pressure Management Indicator (Williams \& Cooper, 1998.
Measured: Start medio October 2010, and end December 2011 (14 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionNov 2011
- Study completionNov 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Animal Assisted TherapyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Life Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gunn Pedersen, Norwegian University of Life Sciences
- Investigators
- Bente Berget, PhD, Principal investigator, Norwegian University of Life Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226017
- Sponsor's protocol ID
- 2010/1589
- Acronym
- Oxytocin2010
- Status last verified
- Nov 2011
- First submitted
- 20 Oct 2010
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Possible Effect of Oxytocin During Interaction Between Humans and Animals
- ClinicalTrials.gov ID
- NCT01226017
- Acronym / sponsor ID
- Oxytocin2010 / 2010/1589
- Conditions
- Animal Assisted Therapy
- Keywords
- Oxytocin, Animal Assisted therapy, Farm animals, Healthy nursing students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Norwegian University of Life SciencesUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 21 Oct 2010 (estimated)
- 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.
The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- woman
- age 20-30 years old
- physical capable of being in a farm environment and have contact with cows
Key exclusion criteria (7 listed)
- pregnancy
- breastfeeding
- anxiety for blood sampling
- anxiety for animals
- allergies
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 |
|---|---|---|
| Measuring oxytocin level in bloodAlso: OxytocinBlood sampling and instruments measuring anxiety and stress | Other | – |
Primary outcome
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.
1 secondary outcome
Self evaluation of anxiety and coping strategies.
Time frame: Start medio October 2010, and end December 2011 (14 months)
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 23 Nov 2011.
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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.
Bente Berget, PhD principal investigator
Norwegian University of Life Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Measuring oxytocin level in blood in people with Animal Assisted Therapy, run by Norwegian University of Life Sciences 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 7 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 23 Nov 2011. 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?
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)). 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 23 Nov 2011.