Medical Clowning and Patient Experiences in a Children's Hospital

Day Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04312217
• Other study ID #: 164/13/03/03/2015
• Status: Completed
• Phase: N/A
• Start date: May 14, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: March 2020
• Source: Helsinki University Central Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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?

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: June 30, 2018
• Est. primary completion date: June 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Day Surgery

Intervention

Behavioral:
• Medical clowning
Medical clowning

Locations

Country	Name	City	State
Finland	Helsinki Children's Hospital	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
Helsinki University Central Hospital	Aalto University

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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