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Effects of Providing Preprint Preoperative Anesthetic Risk Information

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00816699
First Posted: January 5, 2009
Last Update Posted: March 11, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Mahidol University
  Purpose
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group

Condition Intervention Phase
Preoperative Anxiety Other: preprint preoperative anesthetic risk information Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Providing Preprint Preoperative Anesthetic Risk Information

Resource links provided by NLM:


Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • Spielberger State Trait Anxiety Inventory Scale [ Time Frame: 5 days ]

Secondary Outcome Measures:
  • Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia [ Time Frame: 5 days ]

Enrollment: 103
Study Start Date: December 2008
Study Completion Date: September 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00816699


Locations
Thailand
Faculty of Medicine, Siriraj Hospital, Mahidol Unversity
Bangkok, Thailand, 10700
Sponsors and Collaborators
Mahidol University
Investigators
Principal Investigator: Suwannee Suraseranivongse Department of Anesthesiology, Siriraj Hospital
Principal Investigator: Suwannee Suraseranivongse, MD Department of Anesthesiology, Siriraj Hospital
  More Information

Additional Information:
Responsible Party: Effects of providing preprint preoperative anesthetic-risk information, Faculty of Medicine Siriraj hospital, Mahidol University
ClinicalTrials.gov Identifier: NCT00816699     History of Changes
Other Study ID Numbers: Si325/2008
First Submitted: January 1, 2009
First Posted: January 5, 2009
Last Update Posted: March 11, 2011
Last Verified: March 2011

Keywords provided by Mahidol University:
Anxiety
preprint anesthetic risk information

Additional relevant MeSH terms:
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs