Community-Acquired Pneumonia (CAP)NCT06750029
How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia
A study testing Medical clown visits in people with Community-Acquired Pneumonia (CAP), run by Carmel Medical Center at 1 site in Israel.
Trial summary
Background and Objectives: Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child's well-being, vital signs, need for parenteral treatments, and development of complications. Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Community-Acquired Pneumonia (CAP)
- What is being tested?
- Medical clown visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteIsrael
- Study dates
- 30 Oct 2018to 7 Nov 2023
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of pneumonia.
- Ages 2-18 years.
Who cannot join
- Hemodynamically unstable patients.
- Other systemic comorbidities or chronic respiratory diseases
- Children from families unable to comprehend and sign an informed consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Background and Objectives: Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child's well-being, vital signs, need for parenteral treatments, and development of complications. Medical clowns (MCs) are known to assist in reducing pain and alleviating anxiety and have been integrated into many aspects of hospital treatment routines. The aim of this study is to evaluate the effect of MC intervention on length of hospitalization in children admitted with CAP.
- Conditions
- Community-Acquired Pneumonia (CAP)
- Being tested
- Medical clown visits
- Keywords
- Medical clowns, Community-Acquired Pneumonia (CAP)
- Medical subject headings
- Community-Acquired Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical clown visitsOther
Also called Medical Clown
The intervention is 15-minute visits from MCs twice daily during the first two days of admission. The clowns use various techniques to relax the patients (e.g. music, singing, playing, humor, guided imagination) and helpe encourage children to begin drinking and eating on their own.
| Study group | Role | What they receive |
|---|---|---|
| Investigation Group | Experimental | Investigation group will be receiving standard care plus 15-minute MC visits twice daily during the first 48 hours of hospitalization Receives: Other: Medical clown visits |
| Control Group | No intervention | Control Group will be receiving standard care without MC visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The length of hospitalization in hours
The length of hospitalization in hours is determined by the duration between admission and discharge from the pediatric department.
Measured: Immediately after the intervention
Secondary outcomes (1)
Duration of IV treatment
Duration of IV treatment in hours.
Measured: Immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start30 Oct 2018
- Primary completion7 Nov 2023
- Study completion7 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Community-Acquired Pneumonia (CAP)Studies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Yaakobi Bianu, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750029
- Sponsor's protocol ID
- CMC-0170-16
- Status last verified
- Dec 2024
- First submitted
- 6 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Khoury L, Shwartz Naddam I, Paz Tzruia M, Shehadeh S, Konopnicki M, Hamad Saied M, Meiri N, Livnat G, Yaacoby-Bianu K. Medical clown intervention shortens length of hospitalization in children with pneumonia. Sci Rep. 2025 Jun 4;15(1):19498. doi: 10.1038/s41598-025-04706-w.
PubMed 40461561
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia
- ClinicalTrials.gov ID
- NCT06750029
- Acronym / sponsor ID
- CMC-0170-16
- Conditions
- Community-Acquired Pneumonia (CAP)
- Keywords
- Medical clowns, Community-Acquired Pneumonia (CAP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 30 Oct 2018 (actual)
- Primary completion
- 7 Nov 2023 (actual)
- Study completion
- 7 Nov 2023 (actual)
- First posted
- 27 Dec 2024 (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.
Background and Objectives: Community-acquired pneumonia (CAP) is a leading cause of hospitalization in children. The hospitalization duration depends on factors as child's well-being, vital signs, need for parenteral treatments, and development of complications. Medical clowns (MCs) are known to assist in reducing pain and alleviating anxiety and have been integrated into many aspects of hospital treatment routines. The aim of this study is to evaluate the effect of MC intervention on length of hospitalization in children admitted with CAP.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigation Group | Experimental | Other: Medical clown visitsInvestigation group will be receiving standard care plus 15-minute MC visits twice daily during the first 48 hours of hospitalization |
| Control Group | No intervention | –Control Group will be receiving standard care without MC visits. |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of pneumonia.
- Ages 2-18 years.
Key exclusion criteria (3 listed)
- Hemodynamically unstable patients.
- Other systemic comorbidities or chronic respiratory diseases
- Children from families unable to comprehend and sign an informed consent form.
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 |
|---|---|---|
| Medical clown visitsAlso: Medical ClownThe intervention is 15-minute visits from MCs twice daily during the first two days of admission. The clowns use various techniques to relax the patients (e.g. music, singing, playing, humor, guided imagination) and helpe encourage children to begin drinking and eating on their own. | Other | Investigation Group |
Primary outcome
The length of hospitalization in hours
Time frame: Immediately after the intervention
The length of hospitalization in hours is determined by the duration between admission and discharge from the pediatric department.
1 secondary outcome
Duration of IV treatment
Time frame: Immediately after the intervention
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 27 Dec 2024.
- Derived from this study: PubMed 40461561Khoury L, Shwartz Naddam I, Paz Tzruia M, Shehadeh S, Konopnicki M, Hamad Saied M, Meiri N, Livnat G, Yaacoby-Bianu K. Medical clown intervention shortens length of hospitalization in children with pneumonia. Sci Rep. 2025 Jun 4;15(1):19498. doi: 10.1038/s41598-025-04706-w.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical clown visits in people with Community-Acquired Pneumonia (CAP), run by Carmel Medical Center at 1 site in Israel.
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 3 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 27 Dec 2024. 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 Israel. 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?
The length of hospitalization in hours (time frame: Immediately after the intervention). 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 NCT06750029, which also lists 1 linked publication.
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 27 Dec 2024.