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.
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
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.
- 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.
- 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:
- 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.
- Information from an open-ended questionnaire: This information yields mean and standard deviation values along with content analysis for use in our subsequent discussion.
- Conditions
- Stress, Anxiety, Depression
- 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 group | Role | What they receive |
|---|---|---|
| Anesthesiologist | Not described Receives: Other: 2 courseware databases. | |
| Nurse anesthetist | Not described Receives: Other: 2 courseware databases. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
- First posted28 Dec 2011 (estimated)
- Study startApr 2012
- Primary completionOct 2015
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 639 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phongthara Vichitvejpaisal", Mahidol University
- Investigators
- Phongthara Vichitvejpaisal, M.D., Ph.D., Principal investigator, Siriraj Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Principal Investigator
- ClinicalTrials.gov ID
- NCT01500291
- Acronym / sponsor ID
- stress / 315/2554(EC3)
- Conditions
- Stress, Anxiety, Depression
- Keywords
- anesthesia stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 639 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Apr 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Apr 2016 (estimated)
- First posted
- 28 Dec 2011 (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.
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.
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.
- 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.
- 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:
- 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.
- Information from an open-ended questionnaire: This information yields mean and standard deviation values along with content analysis for use in our subsequent discussion.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anesthesiologist | – | Other: 2 courseware databases. |
| Nurse anesthetist | – | Other: 2 courseware databases. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Anesthesiologists and nurse anesthetists who are currently working in the operating rooms.
Key exclusion criteria (1 listed)
- unwilling to join the study
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 |
|---|---|---|
| 2 courseware databases.Also: group A, group BAll participant voluntarily response all items in the SST and SAST courseware database. | Other | Anesthesiologist, Nurse anesthetist |
Primary outcome
scores
Time frame: 2 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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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.
Phongthara Vichitvejpaisal, M.D., Ph.D. principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
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.