Animal Assisted TherapyNCT06414876
Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy
A study testing Hospital dog in people with Animal Assisted Therapy, run by Uppsala University.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Animal Assisted Therapy
- What is being tested?
- Hospital dog
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 2 Feb 2016to 24 May 2017
- 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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalized children
Who cannot join
- Multiresistent bacteria
- Immunosuppressed
- Large burns
About this study
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).
- Conditions
- Animal Assisted Therapy
- Being tested
- Hospital dog
- Keywords
- Children, Hospital, Oxytocin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hospital dogBehavioural
Also called The children played with the hospital dog in about 40 minutes.
The hospital dog always has a well educated dog instructor beside.
| Study group | Role | What they receive |
|---|---|---|
| The children played with the hospital dog and then by themselves. | Experimental | Not described Receives: Behavioral: Hospital dog |
| The children played by themselves and then with the hospital dog. | Experimental | Not described Receives: Behavioral: Hospital dog |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in oxytocin levels
Concentration of oxytocin (pg/mg) in urine samples measured by ELISA.
Measured: Day of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start2 Feb 2016
- Primary completion24 May 2017
- Study completion24 May 2017
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.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414876
- Sponsor's protocol ID
- UOLinCRAAT_Uppsala University
- Status last verified
- May 2024
- First submitted
- 3 May 2024
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Title: Urinary Oxytocin Levels in Children Receiving Animal-Assisted Therapy
- ClinicalTrials.gov ID
- NCT06414876
- Acronym / sponsor ID
- UOLinCRAAT_Uppsala University
- Conditions
- Animal Assisted Therapy
- Keywords
- Children, Hospital, Oxytocin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- 24 May 2017 (actual)
- Study completion
- 24 May 2017 (actual)
- First posted
- 16 May 2024 (actual)
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Hospitalized children
Key exclusion criteria (3 listed)
- Multiresistent bacteria
- Immunosuppressed
- Large burns
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 |
|---|---|---|
| Hospital dogAlso: The children played with the hospital dog in about 40 minutes.The hospital dog always has a well educated dog instructor beside. | Behavioural | The children played by themselves and then with the hospital dog., The children played with the hospital dog and then by themselves. |
Primary outcome
Change in oxytocin levels
Time frame: Day of enrollment
Concentration of oxytocin (pg/mg) in urine samples measured by ELISA.
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 16 May 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hospital dog in people with Animal Assisted Therapy, run by Uppsala University.
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 1 inclusion and 3 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 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Change in oxytocin levels (time frame: Day of enrollment). 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 16 May 2024.