Hospitalization in ChildrenNCT04663815
The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children
A study testing Animal-assisted activity in people with Hospitalization in Children, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Hospitalization in Children
- What is being tested?
- Animal-assisted activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2021to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- hospitalized in the Universitair Ziekenhuis Brussel
- dutch and/or french speaking.
Who cannot join
- decreased immunity
- multi-resistant germs
- disturbed diabetes
- fever of unknown origin
- fear of animals
- dogs or cats allergy
- cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Hospitalization in Children
- Being tested
- Animal-assisted activity, Control intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Animal-assisted activityBehavioural
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 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.
| Study group | Role | What they receive |
|---|---|---|
| AB arm | Other | Animal-assisted activity intervention on 2nd day of hospitalization, control intervention on the 4th day of hospitalization. Receives: Behavioral: Animal-assisted activity; Other: Control intervention |
| BA arm | Other | Control intervention on 2nd day of hospitalization, animal-assisted activity intervention on the 4th day of hospitalization. Receives: Behavioral: Animal-assisted activity; Other: Control intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in heart rate variability (HVR)
A marker of the activity of the sympathetic nervous system.
Measured: 1 hour
Change in systolic and diastolic blood pressure
A marker of the activity of the sympathetic nervous system.
Measured: 1 hour
Change in saliva cortisol
A marker of the activity of the hypothalamic - pituitary - adrenal axis.
Measured: 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.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Apr 2021
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Hospitalization in ChildrenStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Edward Campforts, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04663815
- Sponsor's protocol ID
- Stress-HC-VS
- Status last verified
- Oct 2021
- First submitted
- 2 Dec 2020
- Last updated
- 7 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19095358Gamelin 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.
PubMed 17614016Lesage 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.
PubMed 22965867Al-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.
PubMed 25919580Ursin H, Eriksen HR. The cognitive activation theory of stress. Psychoneuroendocrinology. 2004 Jun;29(5):567-92. doi: 10.1016/S0306-4530(03)00091-X.
PubMed 15041082Nassau 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.
PubMed 17848391Michels 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.
PubMed 24007813Vessey JA. Children's psychological responses to hospitalization. Annu Rev Nurs Res. 2003;21:173-201.
PubMed 12858697
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Animal-assisted Activity on the Stress Level of Hospitalized Children: a Randomized Trial
- ClinicalTrials.gov ID
- NCT04663815
- Acronym / sponsor ID
- Stress-HC-VS
- Conditions
- Hospitalization in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| AB arm | Other | Behavioral: Animal-assisted activity, Other: Control interventionAnimal-assisted activity intervention on 2nd day of hospitalization, control intervention on the 4th day of hospitalization. |
| BA arm | Other | Behavioral: Animal-assisted activity, Other: Control interventionControl intervention on 2nd day of hospitalization, animal-assisted activity intervention on the 4th day of hospitalization. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- hospitalized in the Universitair Ziekenhuis Brussel
- dutch and/or french speaking.
Key exclusion criteria (7 listed)
- decreased immunity
- multi-resistant germs
- disturbed diabetes
- fever of unknown origin
- fear of animals
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Animal-assisted activityThe 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. | Behavioural | AB arm, BA arm |
| Control interventionThe 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 | AB arm, BA arm |
Primary outcome
Change in heart rate variability (HVR)
Time frame: 1 hour
A marker of the activity of the sympathetic nervous system.
Change in systolic and diastolic blood pressure
Time frame: 1 hour
A marker of the activity of the sympathetic nervous system.
Change in saliva cortisol
Time frame: 1 hour
A marker of the activity of the hypothalamic - pituitary - adrenal axis.
Change in visual analogue stress scale
Time frame: 1 hour
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2021.
- Background: PubMed 19095358Hellhammer 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.
- Background: PubMed 17614016Gamelin 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.
- Background: PubMed 22965867Lesage 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.
- Background: PubMed 25919580Al-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.
- Background: PubMed 15041082Ursin H, Eriksen HR. The cognitive activation theory of stress. Psychoneuroendocrinology. 2004 Jun;29(5):567-92. doi: 10.1016/S0306-4530(03)00091-X.
- Background: PubMed 17848391Nassau 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.
- Background: PubMed 24007813Michels 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.
- Background: PubMed 12858697Vessey JA. Children's psychological responses to hospitalization. Annu Rev Nurs Res. 2003;21:173-201.
- Individual participant dataSharing planned: No
Related trials for Hospitalization in Children
Active, not recruiting
Acute Non-severe Osteomyelitis in Children - Outpatient Management Strategy With Oral Antibiotic Therapy Compared to a Standard Strategy With Conventional Hospitalization and Intravenous Antibiotic Therapy: a Randomized Open-label Non-inferiority Study With Bayesian and Medical-economic Analyses.
Osteomyelitis
RecruitingObservational study
Pneumonia and Pleuropneumonia in Hospitalized Children
Pneumonia, Pleural Effusion
Not yet recruitingObservational study
Severe Pediatric Respiratory Syncytial Virus Infections Occurring in the Era of Antiviral Prophylaxis
Children <24 Months Hospitalized for RSV-related Lower Respiratory Tract Infection
RecruitingObservational study
Validation of the D-TAP Parental Questionnaire for Early Screening of Pediatric Feeding Disorder in Hospitalized Children Aged 8 to 18 Months
Pediatric Feeding Disorder, Feeding Difficulties in Infants and Young Children
Enrolling by invitationObservational study
Whole Genome-Based Surveillance of Nasopharyngeal Pneumococcal Carriage in Vietnamese Children
Streptococcus Pneumoniae Carriage, Pneumococcal Colonization
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Campforts, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Animal-assisted activity in people with Hospitalization in Children, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in heart rate variability (HVR) (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04663815, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Oct 2021.