Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy

May 15, 2024 updated by: Uppsala University

There has been growing interest in animal-assisted therapy (AAT) in recent decades due to increasing reports indicating its health benefits for adult patients. These benefits are partly attributed to changes, usually increased levels of the neuropeptide oxytocin.

Aim: To investigate changes in oxytocin levels in hospitalized children during animal-assisted therapy sessions with a certified hospital dog.

Method: Urine samples were collected from 35 hospitalized children (3-17 years) before and after each participant had a session with the hospital dog. Oxytocin levels were analysed with an acetylcholinesterase (AChE) competitive enzyme-linked immunosorbent assay (ELISA). Creatinine levels were measured to determine the subject's fluid intake and then divided by the hormonal concentration (uOT pg/mg).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Hospitalized children

Exclusion Criteria:

  • Multiresistent bacteria
  • Immunosuppressed
  • Large burns

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: The children played with the hospital dog and then by themselves.
Behavioral: Hospital dog
The hospital dog always has a well educated dog instructor beside.
Other Names:
  • The children played with the hospital dog in about 40 minutes.
Experimental: The children played by themselves and then with the hospital dog.
Behavioral: Hospital dog
The hospital dog always has a well educated dog instructor beside.
Other Names:
  • The children played with the hospital dog in about 40 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in oxytocin levels
Time Frame: Day of enrollment
Concentration of oxytocin (pg/mg) in urine samples measured by ELISA.
Day of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

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)

February 2, 2016

Primary Completion (Actual)

May 24, 2017

Study Completion (Actual)

May 24, 2017

Study Registration Dates

First Submitted

May 3, 2024

First Submitted That Met QC Criteria

May 13, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 15, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UOLinCRAAT_Uppsala University

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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