Medical Clowning and Patient Experiences in a Children's Hospital

NCT04312217 | Completed

• 1 other identifier: 164/13/03/03/2015
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Day Surgery

Keywords

patient experience; medical clowning

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Change in anxiety status

  Baseline and 2 hours

Study Arms (2)

Medical clowning

ACTIVE COMPARATOR

Preoperative medical clown exposure

Behavioral: Medical clowning

Control

NO INTERVENTION

Normal preop care

Interventions

Medical clowning BEHAVIORAL

Medical clowning

Medical clowning

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Helsinki University Central Hospital: lead
• Aalto University: collaborator

Study Sites (1)

Helsinki Children's Hospital

Helsinki, 00290, Finland

Location

Related Publications (1)

• 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.

  PMID: 32336267 DERIVED

Study Officials

• Pekka Lahdenne, MD, PhD

  Helsinki University Central Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Digital Services

Model Details: Children and their parents entering day surgery are pre-operatively exposed to medical clowning (N=38) or normal pre-operative care (N=32)

Study Record Dates

• First Submitted: March 12, 2020
• First Posted: March 18, 2020
• Study Start: May 14, 2018
• Primary Completion: June 30, 2018
• Study Completion: June 30, 2018
• Last Updated: March 18, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)