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OpenTrials
Completed

NCT Number: NCT00205244

Preoperative Preparation for Children

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.

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Key information

Conditions

Elective Surgery Anxiety Anxiety Disorders Mental Disorders

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Healing images, relaxation and distraction materials

Behavioral

Primary outcomes

  1. do children who receive the intervention have less anxiety, easier induction and emergence from anesthesia

Secondary outcomes

  1. do children who receive the intervention have fewer changes in post-hospital behaviors

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Preoperative Preparation for Children: Use of Relaxation and Distraction

Important dates

Study start
2004
Primary completion
2007
Study completion
2007
First posted
Sep 20, 2005
Registry last updated
Mar 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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