Cortisol Measurement During Intravenous Access With a Med... | NCT02168998

Studies
Cortisol Measurement During Intravenous Access With a Medical Clown

NCT02168998

Sponsor

Tel-Aviv Sourasky Medical Center

Status

Completed

Last Update Posted

Jul 26, 2018Actual

Enrollment

55Actual

Phase

Not Applicable

Conditions

Stress, Physiological

Interventions

Clown

Countries

Israel

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

Apr 2016

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

Aug 2014

Primary Completion Date

Apr 2016Actual

Completion Date

Apr 2016Actual

First Submitted Date

Jun 18, 2014

First Submission Date that Met QC Criteria

Jun 19, 2014

First Posted Date

Jun 20, 2014Estimated

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

Jul 25, 2018

Last Update Posted Date

Jul 26, 2018Actual

Description Module

Brief 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.

Detailed Description

Not provided

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

55Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
No clown	No Intervention	Routine venipuncture without distraction
Clown	Active Comparator	A medical clown is present in the procedure room during venipuncture	Behavioral: Clown

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Clown	Behavioral	Comparison of routine venipuncture with a distraction technique by a medical clown	Clown

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood Cortisol level		During intravenous cannulation or blood sampling

Secondary Outcomes

Measure	Description	Time Frame
Vital signs (heart rate, respiratory rate, blood pressure)		During intravenous cannulation or blood sampling

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients needing venous blood sampling or insertion of an intravenous canula
Normal development according to parents

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayelet Rimon, MD	Tel-Aviv Sourasky Medical Center	Principal Investigator
Miguel Glatstein, MD	Tel-Aviv Sourasky Medical Center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Tel Aviv Sourasky Medical Center		Tel Aviv		64239	Israel

Intervention Browse Module

MeSH Terms

ID	Term
D027641	Laughter Therapy

Ancestor Terms

ID	Term
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics

Browse Leaves

Not provided

Browse Branches

Not provided