NCT06750029

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 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

Study Start

First participant enrolled

October 30, 2018

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 7, 2023

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
Last Updated

December 27, 2024

Status Verified

December 1, 2024

Enrollment Period

5 years

First QC Date

December 6, 2024

Last Update Submit

December 19, 2024

Conditions

Keywords

Medical clownsCommunity-Acquired Pneumonia (CAP)

Outcome Measures

Primary Outcomes (1)

  • 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.

    Immediately after the intervention

Secondary Outcomes (1)

  • Duration of IV treatment

    Immediately after the intervention

Other Outcomes (8)

  • Changes in well-being scores as reported by both the parent and the treating physician.

    Immediately after the intervention

  • Alterations in Heart rate

    Immediately after the intervention

  • Alterations in body temperature

    Immediately after the intervention

  • +5 more other outcomes

Study Arms (2)

Investigation Group

EXPERIMENTAL

Investigation group will be receiving standard care plus 15-minute MC visits twice daily during the first 48 hours of hospitalization

Other: Medical clown visits

Control Group

NO INTERVENTION

Control Group will be receiving standard care without MC visits.

Interventions

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.

Also known as: Medical Clown
Investigation Group

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Clinical diagnosis of pneumonia.
  • Ages 2-18 years.

You may not qualify if:

  • Hemodynamically unstable patients.
  • Other systemic comorbidities or chronic respiratory diseases
  • Children from families unable to comprehend and sign an informed consent form.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carmel Medical Center

Haifa, Israel

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

Community-Acquired InfectionsInfectionsPneumoniaRespiratory Tract InfectionsRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 6, 2024

First Posted

December 27, 2024

Study Start

October 30, 2018

Primary Completion

November 7, 2023

Study Completion

November 7, 2023

Last Updated

December 27, 2024

Record last verified: 2024-12

Locations