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Preoperative Preparation for Children

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2013 by University of Wisconsin, Madison.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: October 1, 2015
Last verified: August 2013
Children scheduled for elective surgery are randomized into a control and intervention group. Children in the intervention group receive a CD and booklet of relaxation and distraction stories to listen to/read during the preoperative period. Preoperative anxiety is assessed by the child life specialist in the preoperative holding area. Ease of induction and emergence from anesthesia are rated by the anesthesia care provider. Post-hospital behaviors are reported by the parents one week after discharge. It is hypothesized that children receiving the intervention will have less anxiety, easier induction and emergence from anesthesia, and fewer changes in post-hospital behaviors than children in the control group.

Condition Intervention
Elective Surgery
Behavioral: Healing images, relaxation and distraction materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Preparation for Children: Use of Relaxation and Distraction

Resource links provided by NLM:

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • do children who receive the intervention have less anxiety, easier induction and emergence from anesthesia

Secondary Outcome Measures:
  • do children who receive the intervention have fewer changes in post-hospital behaviors

Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   4 Years to 12 Years   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Children between 4-12 years of age scheduled for elective surgery

Exclusion Criteria:

  • Children < 4 years of age or > 12 years of age
  Contacts and Locations
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Please refer to this study by its identifier: NCT00205244

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Joel R Wish University of Wisconsin, Madison
  More Information

Responsible Party: University of Wisconsin, Madison Identifier: NCT00205244     History of Changes
Other Study ID Numbers: M-2003-0495 
Study First Received: September 13, 2005
Last Updated: October 1, 2015
Health Authority: United States: Institutional Review Board processed this record on December 02, 2016