NCT04663815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 2, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

October 7, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

December 2, 2020

Last Update Submit

October 6, 2021

Conditions

Hospitalization in Children

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

AB arm

OTHER

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

Behavioral: Animal-assisted activityOther: Control intervention

BA arm

OTHER

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

Behavioral: Animal-assisted activityOther: Control intervention

Interventions

Animal-assisted activityBEHAVIORAL

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.

AB armBA arm
Control interventionOTHER

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.

AB armBA arm

Eligibility Criteria

Age6 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • hospitalized in the Universitair Ziekenhuis Brussel
  • dutch and/or french speaking.

You may not qualify if:

  • decreased immunity
  • multi-resistant germs
  • disturbed diabetes
  • fever of unknown origin
  • fear of animals
  • dogs or cats allergy
  • cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Jette, 1090, Belgium

Location

Related Publications (8)

  • 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.

    PMID: 19095358BACKGROUND

  • 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.

    PMID: 17614016BACKGROUND

  • 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.

    PMID: 22965867BACKGROUND

  • 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.

    PMID: 25919580BACKGROUND

  • 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.

    PMID: 15041082BACKGROUND

  • 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.

    PMID: 17848391BACKGROUND

  • 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.

    PMID: 24007813BACKGROUND

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

    PMID: 12858697BACKGROUND

Study Officials

  • Edward Campforts, MD, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Randomized clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 11, 2020

Study Start

April 1, 2021

Primary Completion

May 30, 2021

Study Completion

June 30, 2021

Last Updated

October 7, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)