Preoperative Preparation for Children

This study is currently recruiting participants.
Verified August 2013 by University of Wisconsin, Madison
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00205244
First received: September 13, 2005
Last updated: August 16, 2013
Last verified: August 2013
  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

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)
  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

No publications provided

ClinicalTrials.gov Identifier: NCT00205244     History of Changes
Other Study ID Numbers: M-2003-0495
Study First Received: September 13, 2005
Last Updated: August 16, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014