The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children

Study Overview
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Brief Summary
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The aim of this research is to study the effect of an animal-assisted activity (AAA) on the stress level of hospitalized children.

Detailed Description
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A hospitalization is a major stressor in a child's life, which can have negative effects on recovery. It is assumed that animal-assisted interventions can have a positive effect on the level of stress, but this has not yet been sufficiently researched. This study aims to measure a possible effect. Children who are hospitalized will receive an animal-assisted activity. A normal afternoon in their hospital room counts as a control activity. The stress level is measured through saliva cortisol, blood pressure, heart rhythm variability and a visual analogue stress scale.

Official Title
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The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children: a Randomized Trial

Conditions
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Hospitalization in Children

Intervention / Treatment
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* Behavioral: Animal-assisted activity
* Other: Control intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: hospitalized in the Universitair Ziekenhuis Brussel dutch and/or french speaking. Exclusion Criteria: decreased immunity multi-resistant germs disturbed diabetes fever of unknown origin fear of animals dogs or cats allergy cognitive impairment

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AB arm<br>Animal-assisted activity intervention on 2nd day of hospitalization, control intervention on the 4th day of hospitalization. | Behavioral: Animal-assisted activity<br>* The intervention is an animal-assisted activity consisting of a visit to Villa Samson (a place on the campus of the hospital specifically intended for patients to meet pets), where the child will work with a therapy dog for 1 hour. Under supervision, the animal is stroked and combed by the child, they play games together, the child feeds the animal, etc.<br>Other: Control intervention<br>* The control intervention reenacts a normal stay in the hospital, so the child spends one hour in the hospital room where the child can play, watch tv, etc.<br>|
| Other: BA arm<br>Control intervention on 2nd day of hospitalization, animal-assisted activity intervention on the 4th day of hospitalization. | Behavioral: Animal-assisted activity<br>* The intervention is an animal-assisted activity consisting of a visit to Villa Samson (a place on the campus of the hospital specifically intended for patients to meet pets), where the child will work with a therapy dog for 1 hour. Under supervision, the animal is stroked and combed by the child, they play games together, the child feeds the animal, etc.<br>Other: Control intervention<br>* The control intervention reenacts a normal stay in the hospital, so the child spends one hour in the hospital room where the child can play, watch tv, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate variability (HVR) | A marker of the activity of the sympathetic nervous system. | 1 hour | 
| Change in systolic and diastolic blood pressure | A marker of the activity of the sympathetic nervous system. | 1 hour | 
| Change in saliva cortisol | A marker of the activity of the hypothalamic - pituitary - adrenal axis. | 1 hour | 
| Change in visual analogue stress scale | A 10-point scale for patient self-reporting of stress. The scale ranges from 0-10 where 0 indicates a better and 10 indicates a worse outcome. | 1 hour |