Medical Clowning and Patient Experiences in a Children's Hospital

Measuring Patient Experiences in a Children's Hospital With a Medical Clowning Intervention: A Case-Control Study

A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children aged 4-17 years coming for a minor operative procedure including pre-operative cannula insertion will be included. Part of the patients will be exposed to medical clowning intervention and the reference group will be treated preoperatively as routinely without clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will be monitored during the day. A survey on the emotions and expectations of the parents will be done.

Study Overview

• Status: Completed
• Conditions: Day Surgery
• Intervention / Treatment: Behavioral: Medical clowning

Detailed Description

This study aims to measure experiences of children and their parents during day-surgery in hospital setting.

A case-control study is conducted in Helsinki Children's hospital. Altogether 70 children aged 4-17 years coming for a minor operative procedure including pre-operative cannula insertion will be included. Part of the patients will be exposed to medical clowning intervention and the reference group will be treated preoperatively as routinely without clowns. Emotions, anxiety levels, pain caused by the cannula insertion of the children will be monitored during the day. A survey on the emotions and expectations of the parents will be done.

A novel digital survey tool will be used to measure patient experiences before and after the insertion of a venous cannula needed for anaesthesia.

The research questions are as follows:

How does engagement with a medical clown during pre-operative cannulation impact on children and their parents' patient experience? How feasible is a novel data collection tool for measuring patient experience and the impact of an intervention on the patient experience of families?

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00290
    • Helsinki Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• a patient coming for a day surgery (any) procedure in Helsinki Children's Hospital
• understands the Finnish language,
• between 4 and 17 years of age and
• the procedure includes the insertion of a venous cannula.

Exclusion Criteria:

• does not understand the Finnish language
• the child is under 4 years old or 18 years or older
• the procedure does not include the insertion of a cannula but for example mask anaesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medical clowning; Preoperative medical clown exposure	Behavioral: Medical clowning; Medical clowning
No Intervention: Control; Normal preop care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional status	Self reported emotions selected from a list of 11 emotional items. Assessment at baseline and after recovering from anesthesia.	Baseline and 2 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in anxiety status	Self reported anxiety at a scale 1-5. (1=none,..5=very much). Assessment at baseline and after recovering from anesthesia.	Baseline and 2 hours

Collaborators and Investigators

• Sponsor: Helsinki University Central Hospital
• Collaborators: Aalto University
• Investigators: Study Director: Pekka Lahdenne, MD, PhD, Helsinki University Central Hospital

Publications and helpful links

General Publications

• Karisalmi N, Maenpaa K, Kaipio J, Lahdenne P. Measuring patient experiences in a Children's hospital with a medical clowning intervention: a case-control study. BMC Health Serv Res. 2020 Apr 26;20(1):360. doi: 10.1186/s12913-020-05128-2.

Study record dates

Study Major Dates

• Study Start (Actual): May 14, 2018
• Primary Completion (Actual): June 30, 2018
• Study Completion (Actual): June 30, 2018

Study Registration Dates

• First Submitted: March 12, 2020
• First Submitted That Met QC Criteria: March 16, 2020
• First Posted (Actual): March 18, 2020

Study Record Updates

• Last Update Posted (Actual): March 18, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: patient experience; medical clowning
• Other Study ID Numbers: 164/13/03/03/2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No