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

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

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

Study Overview

• Status: Completed
• Conditions: Hospitalization in Children
• Intervention / Treatment: Behavioral: Animal-assisted activity; Other: Control intervention

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Jette, Belgium, 1090
    • UZ Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: Edward Campforts, MD, PhD

Publications and helpful links

General Publications

• Hellhammer DH, Wust S, Kudielka BM. Salivary cortisol as a biomarker in stress research. Psychoneuroendocrinology. 2009 Feb;34(2):163-171. doi: 10.1016/j.psyneuen.2008.10.026. Epub 2008 Dec 18.
• Gamelin FX, Baquet G, Berthoin S, Bosquet L. Validity of the polar S810 to measure R-R intervals in children. Int J Sports Med. 2008 Feb;29(2):134-8. doi: 10.1055/s-2007-964995. Epub 2007 Jul 5.
• Lesage FX, Berjot S, Deschamps F. Clinical stress assessment using a visual analogue scale. Occup Med (Lond). 2012 Dec;62(8):600-5. doi: 10.1093/occmed/kqs140. Epub 2012 Sep 10.
• Al-Yateem NS, Banni Issa W, Rossiter R. Childhood stress in healthcare settings: awareness and suggested interventions. Issues Compr Pediatr Nurs. 2015 Jun;38(2):136-53. doi: 10.3109/01460862.2015.1035465. Epub 2015 Apr 28.
• Ursin H, Eriksen HR. The cognitive activation theory of stress. Psychoneuroendocrinology. 2004 Jun;29(5):567-92. doi: 10.1016/S0306-4530(03)00091-X.
• Nassau JH, Tien K, Fritz GK. Review of the literature: integrating psychoneuroimmunology into pediatric chronic illness interventions. J Pediatr Psychol. 2008 Mar;33(2):195-207. doi: 10.1093/jpepsy/jsm076. Epub 2007 Sep 10.
• Michels N, Sioen I, Clays E, De Buyzere M, Ahrens W, Huybrechts I, Vanaelst B, De Henauw S. Children's heart rate variability as stress indicator: association with reported stress and cortisol. Biol Psychol. 2013 Oct;94(2):433-40. doi: 10.1016/j.biopsycho.2013.08.005. Epub 2013 Sep 2.
• Vessey JA. Children's psychological responses to hospitalization. Annu Rev Nurs Res. 2003;21:173-201.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): May 30, 2021
• Study Completion (Actual): June 30, 2021

Study Registration Dates

• First Submitted: December 2, 2020
• First Submitted That Met QC Criteria: December 10, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 7, 2021
• Last Update Submitted That Met QC Criteria: October 6, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Stress-HC-VS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No