Clinical trial NCT04312217: Medical Clowning and Patient Experiences in a Children's Hospital
Official title: Measuring Patient Experiences in a Children's Hospital With a Medical Clowning Intervention: A Case-Control Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Day Surgery
Keywords: patient experience
medical clowning
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
Collaborators: name: Aalto University
First posted: 2020-03-18
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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?

Eligibility criteria: 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

Primary outcomes:
measure: Change in emotional status
timeFrame: Baseline and 2 hours
Secondary outcomes:
measure: Change in anxiety status
timeFrame: Baseline and 2 hours
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki Children's Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Pekka Lahdenne, MD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.