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CompletedNCT00816699Updated Mar 11, 2011

Effects of Providing Preprint Preoperative Anesthetic Risk Information

A Phase 1/2 interventional study of preprint preoperative anesthetic risk information in Preoperative Anxiety, sponsored by Mahidol University. Completed at 1 site in Thailand. Open to participants aged 16 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-03-11.

Sponsored by Mahidol University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
103
Allocation
Randomized
Ages
16 Years to 80 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Preoperative Anxiety

Keywords

  • Anxiety
  • preprint anesthetic risk information
03

In context

Lead sponsor

Mahidol University is the lead sponsor of 730 studies on the registry; 118 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Patient's refusal
  • Patients scheduled for cardiovascular surgery and neurosurgery
  • Patients with consciousness change following surgery
  • Emergency case
  • CNS or psychological diseases
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • Placebo comparator
    1

    Routine anesthetic risk information

    Other: preprint preoperative anesthetic risk information

  • Active comparator
    2

    Preprint preoperative risk information

    Other: preprint preoperative anesthetic risk information

Interventions

  • Otherpreprint preoperative anesthetic risk information

    preprint preoperative anesthetic risk information

06

What researchers measure

Primary outcomes

  1. Spielberger State Trait Anxiety Inventory Scale

    Time frame: 5 days

Secondary outcomes

  1. Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia

    Time frame: 5 days

07

Study locations

1 site
  • Faculty of Medicine, Siriraj Hospital, Mahidol Unversity
    Bangkok, 10700, Thailand
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00816699
Lead sponsor
Mahidol University
First posted
Jan 5, 2009
Start date
Dec 2008
Primary completion
Aug 2010
Completion
Sep 2010
Last update
Mar 11, 2011

Study contacts

Suwannee Suraseranivongse
principal investigator · Department of Anesthesiology, Siriraj Hospital
Suwannee Suraseranivongse, MD
principal investigator · Department of Anesthesiology, Siriraj Hospital

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2011. You cannot join it, but the record below documents what was studied.

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