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

Hospitalization in Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04663815
• Other study ID #: Stress-HC-VS
• Status: Completed
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2021
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Hospitalization in Children

Intervention

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.

Locations

Country	Name	City	State
Belgium	UZ Brussel	Jette

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

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. — View 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. Epub 2007 Jul 5. — View Citation

Hellhammer DH, Wüst 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. Review. — View 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. — View 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. — View 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. Epub 2007 Sep 10. Review. — View Citation

Ursin H, Eriksen HR. The cognitive activation theory of stress. Psychoneuroendocrinology. 2004 Jun;29(5):567-92. Review. — View Citation

Vessey JA. Children's psychological responses to hospitalization. Annu Rev Nurs Res. 2003;21:173-201. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in heart rate variability (HVR)	A marker of the activity of the sympathetic nervous system.	1 hour
Primary	Change in systolic and diastolic blood pressure	A marker of the activity of the sympathetic nervous system.	1 hour
Primary	Change in saliva cortisol	A marker of the activity of the hypothalamic - pituitary - adrenal axis.	1 hour
Primary	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