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OpenTrials
Completed

NCT Number: NCT02168998

Cortisol Measurement During Intravenous Access With a Medical Clown

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.

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Key information

Conditions

Stress, Physiological

Age range

1 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

clown

Behavioral

Comparison of routine venipuncture with a distraction technique by a medical clown

Primary outcomes

  1. Blood Cortisol level

    Time frame: During intravenous cannulation or blood sampling

Secondary outcomes

  1. Vital signs (heart rate, respiratory rate, blood pressure)

    Time frame: During intravenous cannulation or blood sampling

Sponsors and collaborators

Lead sponsor

Tel-Aviv Sourasky Medical Center

Other Gov

Registry information

Official study title

Level of Cortisol in Stress Response During Intravenous Access in the Pediatric Emergency Department With a Medical Clown: a Randomized Prospective Pilot Study

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 20, 2014
Registry last updated
Jul 26, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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