Clinical trial NCT04663815: The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children
Official title: The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children: a Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hospitalization in Children
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-12-11
Enrollment: 14
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized clinical trial.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in heart rate variability (HVR)
timeFrame: 1 hour
measure: Change in systolic and diastolic blood pressure
timeFrame: 1 hour
measure: Change in saliva cortisol
timeFrame: 1 hour
measure: Change in visual analogue stress scale
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: UZ Brussel
Study officials:
name: Edward Campforts, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Vessey JA. Children's psychological responses to hospitalization. Annu Rev Nurs Res. 2003;21:173-201.