NCT00205244

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 17, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2007

Completed
Last Updated

March 12, 2019

Status Verified

March 1, 2019

Enrollment Period

3.5 years

First QC Date

September 13, 2005

Last Update Submit

March 8, 2019

Conditions

Elective SurgeryAnxiety

Outcome Measures

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

Interventions

Healing images, relaxation and distraction materialsBEHAVIORAL

Eligibility Criteria

Age4 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children between 4-12 years of age scheduled for elective surgery

You may not qualify if:

  • Children \< 4 years of age or \> 12 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Joel R Wish

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

February 17, 2004

Primary Completion

August 16, 2007

Study Completion

August 16, 2007

Last Updated

March 12, 2019

Record last verified: 2019-03

Locations

US(1)