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

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:
  • Medical Clown
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.

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

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.

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