Medical Clowning and Patient Experiences in a Children's Hospital

Study Overview
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Brief Summary
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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.

Detailed Description
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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?

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

Conditions
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Day Surgery

Intervention / Treatment
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* Behavioral: Medical clowning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Children and their parents entering day surgery are pre-operatively exposed to medical clowning (N=38) or normal pre-operative care (N=32)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical clowning<br>Preoperative medical clown exposure | Behavioral: Medical clowning<br>* Medical clowning<br>|
| No Intervention: Control<br>Normal preop care | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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patient experience, medical clowning