Effects of Providing Preprint Preoperative Anesthetic Risk Information

This study has been completed.
Sponsor:
Information provided by:
Mahidol University
ClinicalTrials.gov Identifier:
NCT00816699
First received: January 1, 2009
Last updated: March 10, 2011
Last verified: March 2011
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia [ Time Frame: 5 days ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   16 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

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
Study First Received: January 1, 2009
Last Updated: March 10, 2011
Health Authority: Thailand: Ethical Committee

Keywords provided by Mahidol University:
Anxiety
preprint anesthetic risk information

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014