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NCT00816699 Clinical Trial

Effects of Providing Preprint Preoperative Anesthetic Risk Information

Preoperative Anxiety Clinical Trial

Official title:
Effects of Providing Preprint Preoperative Anesthetic Risk Information

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00816699
Other study ID # Si325/2008
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 1, 2009
Last updated March 10, 2011
Start date December 2008
Est. completion date September 2010

Study information
Verified date March 2011
Source Mahidol University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group

Recruitment information / eligibility
Status Completed
Enrollment 103
Est. completion date September 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• preprint preoperative anesthetic risk information
preprint preoperative anesthetic risk information

Locations
Country Name City State
Thailand Faculty of Medicine, Siriraj Hospital, Mahidol Unversity Bangkok

Sponsors (1)
Lead Sponsor Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome
Type Measure Description Time frame Safety issue
Primary Spielberger State Trait Anxiety Inventory Scale 5 days No
Secondary Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia 5 days No
See also
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Completed NCT03880942 - The Effect of Reading Book on Preoperative Anxiety N/A
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