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StressstressNCT01500291

A Study Survey of Stress in Anesthesia Personnel

An observational study of Stress and Anxiety, run by Mahidol University at 1 site in Thailand.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

It is inevitable that nearly both anesthesiologist and nurse anesthetist take a zero tolerance approach to avoidable safety problems in the provision of anesthesia. We would like to study the stress upon anesthesia personnel by using Suanprung Stress Test (SST) - a well-documented, psychological stress test, and… Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Stress, Anxiety, Depression
What is being tested?
2 courseware databases.
How many people
639 participants
Where
1 siteThailand
Study dates
Apr 2012to Apr 2016
Phase
Observational
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Study population: Two hundred and eighty six out of 1,000 anesthesiologists and three hundred and fifty three out of 3,000 nurse anesthetists are qualified as the final study group.

Who may be able to join

  • Anesthesiologists and nurse anesthetists who are currently working in the operating rooms.

Who cannot join

  • unwilling to join the study

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Faculty of Medicine Siriraj Hospital

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

Official title: Principal Investigator

It is inevitable that nearly both anesthesiologist and nurse anesthetist take a zero tolerance approach to avoidable safety problems in the provision of anesthesia.

We would like to study the stress upon anesthesia personnel by using Suanprung Stress Test (SST) - a well-documented, psychological stress test, and Siriraj Anesthesia-related Stress Test (SAST) - a new developed open-ended opinion poll, to scrutinize the daily rounds stress and yield the solution to eradicate or alleviate those worries as well as improve both physical and mental health to handle the situation of difficulties.

Read the detailed description

This is a prospective study to survey the stress upon anesthesia personnel and verify causes and risk factors to their stress. A message of persuading is conducted among the anesthesia personnel in university, municipal and private hospitals. We ask participants to voluntarily response all items in questionnaires of the SST and SAST.

We launch a communication channel with the anesthesia personnel at www.nmac.in.th and require that qualified participants register and express their intention to join this research project. Each registered participant receives an identification number and a log-in password to the website containing the SST and SAST courseware database. The program is interactive, with personal files for each participant on each test along with other details like code, password, date-month-year, test scores, and log-in periods and time.

We introduced the 20 questionnaires of the SST courseware, to the developed system via http://www.dmh.go.th/test/stress/ before performing it under the research approach via www.nmac.in.th website. The findings revealed that the system operating units were flexible to participants' interactive behavior, instruction and responsiveness. Access to the system through the website provided ready access to the information, was user-friendly, and was stable. In addition, the tools were objective, covered complete details, and were clear, with elements of the subject content in proper order.

  1. SST courseware comprises of 60 questionnaires with scoring through five choices: most stressful (5), highly stressful (4), moderately stressful (3), mildly stressful (2), and no stressful (1). In addition, the tests underwent verification for content validity and had index of item objective congruence (IOC) determined by experts; with > 0.8 in Cronbach's alpha reliability coefficient; r > 0.27 in concurrent validity through calculation of Pearson Product moment correlation against an electromyogram biofeedback.
  2. SAST courseware comprises of 6 sections with scoring through visual analog scale and allowing open-ended opinions. The questionnaires had undergone quality analysis and verification for conciseness, accuracy, and clarity, as well as content and structural validity by three doctorate educational experts with at least a decade of teaching experience. The questionnaires' IOC was 0.79. The open-ended questionnaire is composed of the following sections: (1) background data: age, gender, experience in anesthesia; (2) working data: working time, overnight job, numbers of call; (3) personal data: sleeping time; (4) patient safety issues: frequency of various situations involving unsafe actions, occurrence of operating room events; (5) attitudes toward production pressure: depression, fatigue, confusion, tension/anxiety, and anger; and (6) ratings of sources of production pressure.

We ask participants to voluntarily response all items in the SST and SAST. However, they have rights not to answer any questions that put them in an awkward position.

Target group: Providing the data approximates to 1,000 anesthesiologists and 3,000 nurse anesthetists who have formally performed patient care. Participation is voluntary, without any honorarium, their only benefit is self-awareness of stress. Whether or not they participated does not affect their careers in any way.

Target group size: Two hundred and eighty six out of 1,000 anesthesiologists and three hundred and fifty three out of 3,000 nurse anesthetists are qualified as the final study group.

Procedure: After participants log in with their codes and passwords given to them, they then study the www.nmac.in.th website at their leisure for the content of the SST and SAST designed through questionnaires. Their scores are immediately provided with the completion of a testing courseware and their individual profiles updated as well. Those feeling overwhelmed by the conditions are allowed to withdraw from the project anytime.

During this research, we are willing to answer queries about the project procedure and monitor individual participants' progress through the website while keeping confidential the data about individual participants.

Information analysis:

  1. A psychologist assesses the individual stress, which expressed as mean and standard deviation. All associated factors are compared by the chi-square test. Statistical significance is defined as p < 0.05.
  2. Information from an open-ended questionnaire: This information yields mean and standard deviation values along with content analysis for use in our subsequent discussion.
Being tested
2 courseware databases.
Keywords
anesthesia stress
Medical subject headings
Anxiety Disorders, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 2 courseware databases.Other

    Also called group A, group B

    All participant voluntarily response all items in the SST and SAST courseware database.

Study groups in NCT01500291
Study groupRoleWhat they receive
AnesthesiologistNot described
Receives: Other: 2 courseware databases.
Nurse anesthetistNot described
Receives: Other: 2 courseware databases.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. scores

    A psychologist not directly involves in participants recruitment or contact and locates at a different site performs the interpretation and assessment of the individual stress.

    Measured: 2 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2011 (estimated)
  2. Study startApr 2012
  3. Primary completionOct 2015
  4. Study completionApr 2016 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
639 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01500291
Sponsor's protocol ID
315/2554(EC3)
Other IDs
Si445/2011
Acronym
stress
Status last verified
Mar 2016
First submitted
22 Dec 2011
Last updated
16 Mar 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stress and 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 16 Mar 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

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?

scores (time frame: 2 months). 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 16 Mar 2016.

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