NCT06414876

Brief Summary

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2017

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

May 3, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 16, 2024

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

1.3 years

First QC Date

May 3, 2024

Last Update Submit

May 15, 2024

Conditions

Keywords

ChildrenHospitalOxytocin

Outcome Measures

Primary Outcomes (1)

  • Change in oxytocin levels

    Concentration of oxytocin (pg/mg) in urine samples measured by ELISA.

    Day of enrollment

Study Arms (2)

The children played with the hospital dog and then by themselves.

EXPERIMENTAL
Behavioral: Hospital dog

The children played by themselves and then with the hospital dog.

EXPERIMENTAL
Behavioral: Hospital dog

Interventions

Hospital dogBEHAVIORAL

The hospital dog always has a well educated dog instructor beside.

Also known as: The children played with the hospital dog in about 40 minutes.
The children played by themselves and then with the hospital dog.The children played with the hospital dog and then by themselves.

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Hospitalized children

You may not qualify if:

  • Multiresistent bacteria
  • Immunosuppressed
  • Large burns

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2024

First Posted

May 16, 2024

Study Start

February 2, 2016

Primary Completion

May 24, 2017

Study Completion

May 24, 2017

Last Updated

May 16, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share