Stress, PhysiologicalNCT02168998
Cortisol Measurement During Intravenous Access With a Medical Clown
A study testing Clown in people with Stress, Physiological, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood. Read more about this study
- Who is it for?
- Ages 1 year to 10 years
- Conditions the study is for
- Stress, Physiological
- 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
- 55 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2014to Apr 2016
- 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 1 year to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients needing venous blood sampling or insertion of an intravenous canula
- Normal development according to parents
Who cannot join
- Critically ill children (e.g. shock, respiratory distress or failure)
- Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
- Known adrenal or pituitary disease
- Children who have received glucocorticoids during the preceeding six weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study
The purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.
- Conditions
- Stress, Physiological
- Being tested
- Clown
- Keywords
- Medical clown, Pediatric emergency medicine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClownBehavioural
Comparison of routine venipuncture with a distraction technique by a medical clown
| Study group | Role | What they receive |
|---|---|---|
| No clown | No intervention | Routine venipuncture without distraction |
| Clown | Active comparator | A medical clown is present in the procedure room during venipuncture Receives: Behavioral: Clown |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood Cortisol level
Measured: During intravenous cannulation or blood sampling
Secondary outcomes (1)
Vital signs (heart rate, respiratory rate, blood pressure)
Measured: During intravenous cannulation or blood sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PhysiologicalStudies 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
- 55 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 CenterMiguel Glatstein, MD, Study director, Tel-Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168998
- Sponsor's protocol ID
- 0261-14-TLV
- Status last verified
- Apr 2016
- First submitted
- 18 Jun 2014
- Last updated
- 26 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study
- ClinicalTrials.gov ID
- NCT02168998
- Acronym / sponsor ID
- 0261-14-TLV
- Conditions
- Stress, Physiological
- Keywords
- Medical clown, Pediatric emergency medicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 20 Jun 2014 (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 purpose of this study is to determine whether the presence of a medical clown in a pediatric emergency department procedure room would reduce children's anxiety. The investigators hypothesize that this positive influence will be expressed as lower levels of the stress hormone (Cortisol) in the blood.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No clown | No intervention | –Routine venipuncture without distraction |
| Clown | Active comparator | Behavioral: ClownA medical clown is present in the procedure room during venipuncture |
Who may qualify
- Ages
- 1 year to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Patients needing venous blood sampling or insertion of an intravenous canula
- Normal development according to parents
Key exclusion criteria (4 listed)
- Critically ill children (e.g. shock, respiratory distress or failure)
- Children whose blood work or intravenous canula must be obtained rapidly for therapeutic reasons (e.g. antibiotic administration in a patient with severe bacterial infections)
- Known adrenal or pituitary disease
- Children who have received glucocorticoids during the preceeding six weeks
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 |
|---|---|---|
| ClownComparison of routine venipuncture with a distraction technique by a medical clown | Behavioural | Clown |
Primary outcome
Blood Cortisol level
Time frame: During intravenous cannulation or blood sampling
1 secondary outcome
Vital signs (heart rate, respiratory rate, blood pressure)
Time frame: During intravenous cannulation or blood sampling
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 26 Jul 2018.
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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
Miguel Glatstein, MD study director
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 Stress, Physiological, 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 2 inclusion and 4 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 26 Jul 2018. 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?
Blood Cortisol level (time frame: During intravenous cannulation or blood sampling). 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 26 Jul 2018.