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Completed

NCT Number: NCT04312217

Medical Clowning and Patient Experiences in a Children's Hospital

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.

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Key information

Conditions

Day Surgery

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helsinki Children's Hospital

Helsinki, 00290, Finland

About this study

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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Medical clowning

Behavioral

Medical clowning

Primary outcomes

  1. Change in emotional status

    Time frame: Baseline and 2 hours

    Self reported emotions selected from a list of 11 emotional items. Assessment at baseline and after recovering from anesthesia.

Secondary outcomes

  1. Change in anxiety status

    Time frame: Baseline and 2 hours

    Self reported anxiety at a scale 1-5. (1=none,..5=very much). Assessment at baseline and after recovering from anesthesia.

Sponsors and collaborators

Lead sponsor

Helsinki University Central Hospital

Other

Collaborators

  • Aalto University

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Mar 18, 2020
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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