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Completed

NCT Number: NCT04663815

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

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

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Key information

Conditions

Hospitalization in Children

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UZ Brussel

Jette, 1090, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Animal-assisted activity

Behavioral

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.

Control intervention

Other

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.

Primary outcomes

  1. Change in heart rate variability (HVR)

    Time frame: 1 hour

    A marker of the activity of the sympathetic nervous system.

  2. Change in systolic and diastolic blood pressure

    Time frame: 1 hour

    A marker of the activity of the sympathetic nervous system.

  3. Change in saliva cortisol

    Time frame: 1 hour

    A marker of the activity of the hypothalamic - pituitary - adrenal axis.

  4. Change in visual analogue stress scale

    Time frame: 1 hour

    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.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Oct 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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