Preoperative AnxietyPhase 1/2NCT00816699
Effects of Providing Preprint Preoperative Anesthetic Risk Information
A Phase 1/2 study testing preprint preoperative anesthetic risk information in people with Preoperative Anxiety, run by Mahidol University at 1 site in Thailand.
Trial summary
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Preoperative Anxiety
- What is being tested?
- preprint preoperative anesthetic risk information
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2008to Sep 2010
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
- Low to moderate risk surgery
Who cannot join
- Patient's refusal
- Patients scheduled for cardiovascular surgery and neurosurgery
- Patients with consciousness change following surgery
- Emergency case
- CNS or psychological diseases
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Siriraj Hospital, Mahidol Unversity
Bangkok, 10700
About this study
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group
- Conditions
- Preoperative Anxiety
- Being tested
- preprint preoperative anesthetic risk information
- Keywords
- Anxiety, preprint anesthetic risk information
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preprint preoperative anesthetic risk informationOther
preprint preoperative anesthetic risk information
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Routine anesthetic risk information Receives: Other: preprint preoperative anesthetic risk information |
| 2 | Active comparator | Preprint preoperative risk information Receives: Other: preprint preoperative anesthetic risk information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spielberger State Trait Anxiety Inventory Scale
Measured: 5 days
Secondary outcomes (1)
Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preoperative AnxietyStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Investigators
- Suwannee Suraseranivongse, Principal investigator, Department of Anesthesiology, Siriraj HospitalSuwannee Suraseranivongse, MD, Principal investigator, Department of Anesthesiology, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00816699
- Sponsor's protocol ID
- Si325/2008
- Status last verified
- Mar 2011
- First submitted
- 1 Jan 2009
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Providing Preprint Preoperative Anesthetic Risk Information
- ClinicalTrials.gov ID
- NCT00816699
- Acronym / sponsor ID
- Si325/2008
- Conditions
- Preoperative Anxiety
- Keywords
- Anxiety, preprint anesthetic risk information
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 5 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Proportion of patients in study group(preprint preoperative anesthetic risk should have more anxiety, more knowledge, and more cancellation than controlled group
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: preprint preoperative anesthetic risk informationRoutine anesthetic risk information |
| 2 | Active comparator | Other: preprint preoperative anesthetic risk informationPreprint preoperative risk information |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Inpatients scheduled for surgery under general anesthesia with or without regional anesthesia
- Low to moderate risk surgery
Key exclusion criteria (5 listed)
- Patient's refusal
- Patients scheduled for cardiovascular surgery and neurosurgery
- Patients with consciousness change following surgery
- Emergency case
- CNS or psychological diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preprint preoperative anesthetic risk informationpreprint preoperative anesthetic risk information | Other | 1, 2 |
Primary outcome
Spielberger State Trait Anxiety Inventory Scale
Time frame: 5 days
1 secondary outcome
Knowledge, proportion of patients who cancel surgery, proportion who refuse regional anesthesia
Time frame: 5 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suwannee Suraseranivongse principal investigator
Department of Anesthesiology, Siriraj Hospital
Suwannee Suraseranivongse, MD principal investigator
Department of Anesthesiology, Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing preprint preoperative anesthetic risk information in people with Preoperative Anxiety, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Spielberger State Trait Anxiety Inventory Scale (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2011.