## Protocol Section
### Identification Module
**NCT ID:** NCT06414876

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

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

#### Organization Study ID Info
**ID:** UOLinCRAAT_Uppsala University
#### Organization
**Class:** OTHER
**Full Name:** Uppsala University
### Status Module
#### Completion Date
**Date:** 2017-05-24

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2017-05-24

**Type:** ACTUAL

#### Start Date
**Date:** 2016-02-02

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-03
**Study First Submit QC Date:** 2024-05-13
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Uppsala University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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).

### Conditions Module

**Conditions:**

- Animal Assisted Therapy

**Keywords:**

- Children

- Hospital

- Oxytocin

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** CROSSOVER

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 50

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Hospital dog

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

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Hospital dog

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

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

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

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

**Description:** The hospital dog always has a well educated dog instructor beside.

**Name:** Hospital dog

**Other Names:**

- The children played with the hospital dog in about 40 minutes.

**Type:** BEHAVIORAL

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Change in oxytocin levels

**Time Frame:** Day of enrollment

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Hospitalized children

Exclusion Criteria:

* Multiresistent bacteria
* Immunosuppressed
* Large burns

**Maximum Age:** 17 Years

**Minimum Age:** 3 Years

**Sex:** ALL

**Standard Ages:**

- CHILD

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: Repr

- Name: Reproductive Control Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13041

- Name: Oxytocin

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
