Preoperative Preparation for Children

NCT ID: NCT00205244

Last Updated: 2019-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-17

Study Completion Date

2007-08-16

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elective Surgery Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Healing images, relaxation and distraction materials

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Wisconsin, Madison

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joel R Wish

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Wisconsin

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

M-2003-0495

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mindfulness Surgical Pain Outcomes
NCT05838443 COMPLETED NA
Stress and Sleep Study
NCT05218109 COMPLETED NA