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A Possible Effect of Oxytocin During Interaction Between Humans and Animals

Plain-language guide to NCT01226017: not phased interventional trial of Oxytocin, 18 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT01226017
Phase
not phased
Status
completed
Start
2010-10
Completion (planned or actual)
2011-11
Participants
18 (actual)
Design
na, open label (everyone knows who gets what), basic_science
Conditions studied
Animal Assisted Therapy
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

The trial (not phased) is built around Oxytocin.

The purpose of this pilot study is to investigate the possible change of Oxytocin level in human blood after positive interaction with farm animals.

The registry classes the interventions as other.

More on the Plan

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.

Who Took Part

The registry lists 18 actual participants took part.

It was open to women only aged from 20 years up to 30 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Age 20-30 years old. Physical capable of being in a farm environment and have contact with cows.

The full record lists 3 inclusion and 7 exclusion criteria; among the exclusions: anxiety for blood sampling; anxiety for animals; psychiatric diagnoses.

How the Study Was Run

It was run as a single-group and open-label study.

Everyone knew when Oxytocin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2010-10 with completion listed for 2011-11.

It ran at 1 site in Norway.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (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)).

It also tracked 1 secondary outcome, for example Self evaluation of anxiety and coping strategies.

What This Means in Plain Language

Put simply, this is a not phased trial of Oxytocin in 18 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Oxytocin compound page, all human trials.

Our Notes on the Compound

Oxytocin: A peptide hormone with established obstetric medical uses and a less settled role in research on behavior, sexual function and appetite.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.