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Preoperative Preparation for Children
This study is currently recruiting participants.
Verified by University of Wisconsin, Madison, September 2005
Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205244
  Purpose

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
Anxiety
Behavioral: Healing images, relaxation and distraction materials

MedlinePlus related topics: Anesthesia Anxiety
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
Official Title: Preoperative Preparation for Children: Use of Relaxation and Distraction

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

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00205244

Contacts
Contact: Joel R Wish 608-262-2032 jr.wish@hosp.wisc.edu

Locations
United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53792
Contact: Joel R Wish     608-262-2032     jr.wish@hosp.wisc.edu    
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Joel R Wish University of Wisconsin, Madison
  More Information

Study ID Numbers: M-2003-0495
Study First Received: September 13, 2005
Last Updated: October 24, 2007
ClinicalTrials.gov Identifier: NCT00205244  
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on January 16, 2009