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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00205244
Other study ID # M-2003-0495
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 17, 2004
Est. completion date August 16, 2007

Study information

Verified date March 2019
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date August 16, 2007
Est. primary completion date August 16, 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 4 Years to 12 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Healing images, relaxation and distraction materials


Locations

Country Name City State
United States University of Wisconsin Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary do children who receive the intervention have less anxiety, easier induction and emergence from anesthesia
Secondary do children who receive the intervention have fewer changes in post-hospital behaviors
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