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Preoperative Preparation for Children

This study is currently recruiting participants.
Verified March 2017 by University of Wisconsin, Madison
Sponsor:
ClinicalTrials.gov Identifier:
NCT00205244
First Posted: September 20, 2005
Last Update Posted: March 31, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Wisconsin, Madison
  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
Intervention Model: Single Group Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00205244     History of Changes
Other Study ID Numbers: M-2003-0495
First Submitted: September 13, 2005
First Posted: September 20, 2005
Last Update Posted: March 31, 2017
Last Verified: March 2017