Day SurgeryNCT04312217
Medical Clowning and Patient Experiences in a Children's Hospital
A study testing Medical clowning in people with Day Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 17 years
- Conditions the study is for
- Day Surgery
- What is being tested?
- Medical clowning
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteFinland
- Study dates
- 14 May 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Measuring Patient Experiences in a Children's Hospital With a Medical Clowning Intervention: A Case-Control Study
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.
Read the 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?
- Conditions
- Day Surgery
- Being tested
- Medical clowning
- Keywords
- patient experience, medical clowning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medical clowningBehavioural
Medical clowning
| Study group | Role | What they receive |
|---|---|---|
| Medical clowning | Active comparator | Preoperative medical clown exposure Receives: Behavioral: Medical clowning |
| Control | No intervention | Normal preop care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emotional status
Self reported emotions selected from a list of 11 emotional items. Assessment at baseline and after recovering from anesthesia.
Measured: Baseline and 2 hours
Secondary outcomes (1)
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.
Measured: Baseline and 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start14 May 2018
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Day SurgeryStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Aalto University
- Responsible party
- Principal investigator, Pekka Lahdenne, Helsinki University Central Hospital
- Investigators
- Pekka Lahdenne, MD, PhD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312217
- Sponsor's protocol ID
- 164/13/03/03/2015
- Status last verified
- Mar 2020
- First submitted
- 12 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32336267
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measuring Patient Experiences in a Children's Hospital With a Medical Clowning Intervention: A Case-Control Study
- ClinicalTrials.gov ID
- NCT04312217
- Acronym / sponsor ID
- 164/13/03/03/2015
- Conditions
- Day Surgery
- Keywords
- patient experience, medical clowning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Aalto University
- Study start
- 14 May 2018 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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)
| Arm | Type | Receives |
|---|---|---|
| Medical clowning | Active comparator | Behavioral: Medical clowningPreoperative medical clown exposure |
| Control | No intervention | –Normal preop care |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medical clowningMedical clowning | Behavioural | Medical clowning |
Primary outcome
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.
1 secondary outcome
Change in anxiety status
Time frame: Baseline and 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Derived from this study: PubMed 32336267Karisalmi 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pekka Lahdenne, MD, PhD study director
Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medical clowning in people with Day Surgery, run by Helsinki University Central Hospital at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in emotional status (time frame: Baseline and 2 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04312217, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.