Effects of Providing Preprint Preoperative Anesthetic Risk Information

March 10, 2011 updated by: Mahidol University
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

103

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10700
        • Faculty of Medicine, Siriraj Hospital, Mahidol Unversity

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
  • Low to moderate risk surgery

Exclusion Criteria:

  • Patient's refusal
  • Patients scheduled for cardiovascular surgery and neurosurgery
  • Patients with consciousness change following surgery
  • Emergency case
  • CNS or psychological diseases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 1
Routine anesthetic risk information
Other: preprint preoperative anesthetic risk information
preprint preoperative anesthetic risk information
Active Comparator: 2
Preprint preoperative risk information
Other: preprint preoperative anesthetic risk information
preprint preoperative anesthetic risk information

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Spielberger State Trait Anxiety Inventory Scale
Time Frame: 5 days
5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Investigators

  • Principal Investigator: Suwannee Suraseranivongse, Department of Anesthesiology, Siriraj Hospital
  • Principal Investigator: Suwannee Suraseranivongse, MD, Department of Anesthesiology, Siriraj Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 1, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (Estimate)

January 5, 2009

Study Record Updates

Last Update Posted (Estimate)

March 11, 2011

Last Update Submitted That Met QC Criteria

March 10, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Si325/2008

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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