- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06750029
How Does Medical Clown Intervention Affect the Length of Hospitalization in Children With Pneumonia
December 19, 2024 updated by: Karin Yaakobi Bianu, Carmel Medical Center
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
51
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Haifa, Israel
- Carmel Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Clinical diagnosis of pneumonia.
- Ages 2-18 years.
Exclusion Criteria:
- Hemodynamically unstable patients.
- Other systemic comorbidities or chronic respiratory diseases
- Children from families unable to comprehend and sign an informed consent form.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Investigation Group
Investigation group will be receiving standard care plus 15-minute MC visits twice daily during the first 48 hours of hospitalization
|
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.
Other Names:
|
|
No Intervention: Control Group
Control Group will be receiving standard care without MC visits.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Immediately after the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of IV treatment
Time Frame: Immediately after the intervention
|
Duration of IV treatment in hours.
|
Immediately after the intervention
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in well-being scores as reported by both the parent and the treating physician.
Time Frame: Immediately after the intervention
|
Changes in well-being scores as reported by both the parent and the treating physician, and alterations in vital signs and laboratory results.
|
Immediately after the intervention
|
|
Alterations in Heart rate
Time Frame: Immediately after the intervention
|
Alterations in Heart rate
|
Immediately after the intervention
|
|
Alterations in body temperature
Time Frame: Immediately after the intervention
|
Alterations in body temperature
|
Immediately after the intervention
|
|
Alterations in Respiratory rate
Time Frame: Immediately after the intervention
|
Alterations in Respiratory rate
|
Immediately after the intervention
|
|
Alterations in oxygen saturation
Time Frame: Immediately after the intervention
|
Alterations in oxygen saturation
|
Immediately after the intervention
|
|
Alterations in white blood cell count
Time Frame: Immediately after the intervention
|
Alterations in white blood cell count
|
Immediately after the intervention
|
|
Alterations in absolute neutrophil count
Time Frame: Immediately after the intervention
|
Alterations in absolute neutrophil count
|
Immediately after the intervention
|
|
Alterations in C-reactive protein levels
Time Frame: Immediately after the intervention
|
Alterations in C-reactive protein levels
|
Immediately after the intervention
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 30, 2018
Primary Completion (Actual)
November 7, 2023
Study Completion (Actual)
November 7, 2023
Study Registration Dates
First Submitted
December 6, 2024
First Submitted That Met QC Criteria
December 19, 2024
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 19, 2024
Last Verified
December 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMC-0170-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Community-Acquired Pneumonia (CAP)
-
University of Maryland, BaltimoreNot yet recruitingCommunity Acquired Pneumonia (CAP)United States
-
Capital Medical UniversityChina-Japan Friendship Hospital; Beijing Municipal Health CommissionNot yet recruitingCommunity Acquired Pneumonia (CAP)China
-
National Research Institute of Chinese Medicine...StatPlus,Inc.Not yet recruitingCommunity-Acquired Pneumonia (CAP) | Intravenous | Antibiotic Therapy | Hospitalisation | Mild to ModerateTaiwan
-
Ann & Robert H Lurie Children's Hospital of ChicagoPatient-Centered Outcomes Research InstituteRecruitingCommunity Acquired Pneumonia | Community Acquired Pneumonia (CAP)United States
-
Copenhagen Respiratory ResearchRecruitingCommunity Acquired Pneumonia (CAP)Denmark
-
PfizerActive, not recruitingCommunity-Acquired Pneumonia (CAP)United States
-
Societa Italiana di PneumologiaRecruitingCommunity Acquired Pneumonia (CAP)Italy
-
Jeffrey PernicaRecruitingPneumonia | Community-Acquired Pneumonia (CAP)Canada
-
Azienda Ospedaliero-Universitaria CareggiCompletedPneumonia | Community Acquired Pneumonia | Emergency | Community Acquired Pneumonia (CAP) | Multi Drug Resistant Organisms | Pneumonia - Bacterial | Community Acquired Pneumonia, Severe | Multi Drug ResistantItaly
-
Children's Hospital of PhiladelphiaPatient-Centered Outcomes Research InstituteActive, not recruitingSinusitis | Community Acquired Pneumonia (CAP) | Acute Otitis Media (AOM) | Strep PharyngitisUnited States
Clinical Trials on Medical clown visits
-
University of ViennaRED NOSES Clowndoctors AustriaNot yet recruitingPhysiological Stress | Subjective Stress | Mood States
-
Meir Medical CenterTerminatedVelopharyngeal Insufficiency
-
Hillel Yaffe Medical CenterUnknown
-
Meir Medical CenterUnknownChildren Referred to the Pediatric Emergency DepartmentIsrael
-
Bnai Zion Medical CenterRecruitingChild, Only | EEG With Periodic AbnormalitiesIsrael
-
Hillel Yaffe Medical CenterUnknown
-
Soroka University Medical CenterCompletedInguinal Hernia | Umbilical HerniaIsrael
-
The Baruch Padeh Medical Center, PoriyaUnknownLabor Pain | Mental Status Change
-
National Institute of Medical Sciences and Nutrition...CompletedImpact of a Hybrid Medical Care Model in the Rheumatoid Arthritis Patient-reported-outcomes MeasuresRheumatoid Arthritis | TelehealthMexico
-
University of ManitobaRecruitingMental Health Care | Pilot Study | Anxiety and DepressionCanada