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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014