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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04663815
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : October 7, 2021
Sponsor:
Information provided by (Responsible Party):
Universitair Ziekenhuis Brussel

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

Condition or disease Intervention/treatment Phase
Hospitalization in Children Behavioral: Animal-assisted activity Other: Control intervention Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Randomized clinical trial.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children: a Randomized Trial
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : May 30, 2021
Actual Study Completion Date : June 30, 2021

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Arms and Interventions
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Arm Intervention/treatment
AB arm
Animal-assisted activity intervention on 2nd day of hospitalization, control intervention on the 4th day of hospitalization.
 Behavioral: Animal-assisted activity
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.

Other: Control intervention
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.
BA arm
Control intervention on 2nd day of hospitalization, animal-assisted activity intervention on the 4th day of hospitalization.
 Behavioral: Animal-assisted activity
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.

Other: Control intervention
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.


Outcome Measures
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Primary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04663815


Locations
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Belgium
UZ Brussel
Jette, Belgium, 1090
Sponsors and Collaborators
Universitair Ziekenhuis Brussel
Investigators
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Principal Investigator: Edward Campforts, MD, PhD
More Information
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Publications:

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Responsible Party: Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT04663815    
Other Study ID Numbers: Stress-HC-VS
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: October 7, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No