Medical Clowning and Patient Experiences in a Children's... | NCT04312217

Studies
Medical Clowning and Patient Experiences in a Children's Hospital

NCT04312217

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Mar 18, 2020Actual

Enrollment

70Actual

Phase

Not Applicable

Conditions

Day Surgery

Interventions

Medical clowning

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 14, 2018Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Mar 12, 2020

First Submission Date that Met QC Criteria

Mar 16, 2020

First Posted Date

Mar 18, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 16, 2020

Last Update Posted Date

Mar 18, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pekka Lahdenne, Head of Digital Services, Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
Aalto University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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?

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Medical clowning	Active Comparator	Preoperative medical clown exposure	Behavioral: Medical clowning
Control	No Intervention	Normal preop care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Medical clowning	Behavioral	Medical clowning	Medical clowning

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 Years

Maximum Age

17 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pekka Lahdenne, MD, PhD	Helsinki University Central Hospital	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki Children's Hospital		Helsinki		00290	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32336267	Derived	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.