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

NCT ID: NCT04663815

Last Updated: 2021-10-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2021-06-30

Brief Summary

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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

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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.

Conditions

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Hospitalization in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Randomized clinical trial.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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AB arm

Animal-assisted activity intervention on 2nd day of hospitalization, control intervention on the 4th day of hospitalization.

Group Type OTHER

Animal-assisted activity

Intervention Type 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

Intervention Type 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.

BA arm

Control intervention on 2nd day of hospitalization, animal-assisted activity intervention on the 4th day of hospitalization.

Group Type OTHER

Animal-assisted activity

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Edward Campforts, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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UZ Brussel

Jette, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type BACKGROUND
PMID: 19095358 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17614016 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22965867 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25919580 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15041082 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17848391 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24007813 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12858697 (View on PubMed)

Other Identifiers

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Stress-HC-VS

Identifier Type: -

Identifier Source: org_study_id

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