PainNCT01396876
The Effects of Medical Clowns in Children Undergoing Blood Tests
A study testing clown in people with Pain and Anxiety, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- What is being tested?
- clown
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2011to Dec 2012
- 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 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children needing venous blood sampling or the insertion of an intravenous canula
Who cannot join
- Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
- Absence of a parent during the procedure
- Abnormal development according to parents
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial
The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.
Read the detailed description
Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.
- Being tested
- clown
- Keywords
- Medical clown, Pediatric emergency medicine, Emergency procedures
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clownBehavioural
a distraction technique is performed by a clown during venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Clown | Active comparator | A clown is present during venipuncture Receives: Behavioral: clown |
| No clown | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
recorded by the child
Measured: at the end of the procedure
Secondary outcomes (3)
Parental anxiety level
recorded by the parent
Measured: at the end of the procedure
Procedure's success rate
recorded by the nurse
Measured: at the end of the procedure
Overall report of procedure's comfort
recorded by the nurse
Measured: at the end of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ayelet Rimon, MD, Principal investigator, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01396876
- Sponsor's protocol ID
- TASMC-11-SR-525-CTIL
- Status last verified
- Jun 2014
- First submitted
- 17 Jul 2011
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Hospital Clown's Performance in the Procedure Room of a Pediatric Emergency Department: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01396876
- Acronym / sponsor ID
- TASMC-11-SR-525-CTIL
- Keywords
- Medical clown, Pediatric emergency medicine, Emergency procedures
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jul 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 19 Jul 2011 (estimated)
- 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.
The investigators hypothesized that the participation of therapeutic clowns in the pediatric emergency department procedure room would reduce anxiety, improve the level of cooperation children can provide and avoid some of the adverse effects.
Detailed description
Research has demonstrated that cognitive psychological techniques, including distraction, can increase pain tolerance. Humor can be an important intervention, able to reduce stress to both the child and the parent. In the last decade there has been a rapid growth in the presence of therapeutic clowns in hospital, particularly in pediatric settings. If therapeutic clowns are shown to positively affect any of the parameters being measured in this study, they should be included as aprt of the standard of care in the pediatric emergency setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clown | Active comparator | Behavioral: clownA clown is present during venipuncture |
| No clown | No intervention | – |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children needing venous blood sampling or the insertion of an intravenous canula
Key exclusion criteria (3 listed)
- Children whose blood work or intravenous line must be accomplished rapidly for therapeutic reasons
- Absence of a parent during the procedure
- Abnormal development according to parents
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 |
|---|---|---|
| clowna distraction technique is performed by a clown during venipuncture | Behavioural | Clown |
Primary outcome
Pain score
Time frame: at the end of the procedure
recorded by the child
3 secondary outcomes
Parental anxiety level
Time frame: at the end of the procedure
Procedure's success rate
Time frame: at the end of the procedure
Overall report of procedure's comfort
Time frame: at the end of the procedure
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 19 Jun 2014.
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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.
Ayelet Rimon, MD principal investigator
Tel-Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing clown in people with Pain and Anxiety, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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 1 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 19 Jun 2014. 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 Israel. 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?
Pain score (time frame: at the end of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Jun 2014.