Preoperative Preparation for Children

Anxiety Clinical Trial

Official title:

Preoperative Preparation for Children: Use of Relaxation and Distraction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00205244
• Other study ID #: M-2003-0495
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Elective Surgery

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