Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of IndonesiaNCT04279353
Effectiveness of Mindfulness Based Intervention in Reducing Stress Levels of Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
A study testing Mindfulness Based Intervention in people with Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
This study was conducted to determine the effectiveness of MBI technique in reducing the stress level of anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
- What is being tested?
- Mindfulness Based Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIndonesia
- Study dates
- 25 Jul 2019to 31 Aug 2019
- Phase
- Interventional
- 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
The inclusion criteria for participation were being anesthesiology and intensive therapy resident stationed in Cipto Mangunkusumo Hospital, having a PSS-10 score ≥ 14, and agreeing to fully participate in the study.
The exclusion criteria for this study were: (1) residents who used narcotic/psychotropic drugs during the study period and (2) residents who were not able to complete the study or attend the formal face-to-face training as scheduled due to conflicting work schedule.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official title: Effectiveness of Mindfulness Based Intervention (MBI) Technique in Reducing Stress Levels of Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
This study was conducted to determine the effectiveness of MBI technique in reducing the stress level of anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia.
Read the detailed description
This research was an experimental study with paired one group design. The research subjects were anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia in 2019. The MBI program lasted four weeks, consisted of one formal face-to-face training and informal training through homework carried out every day for four weeks. 13 study subjects met the inclusion criteria and did not enter the exclusion criteria. 1 study subject must be excluded because it did not complete the informal training. Data collection on the Perceived Stress Scale 10 Item (PSS-10) was conducted in July and August 2019.
- Conditions
- Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
- Being tested
- Mindfulness Based Intervention
- Keywords
- Stress, Resident, Anesthesiologist, Mindfulness, Medical, Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Based InterventionOther
this intervention is a 4 weeks program with logbook and follow up during intervention
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Participants was asked to answer PSS-10 questionnaire to measure their stress level, then they received Mindfulness Based Intervention program for 4 weeks and did the PSS-10 test again after 4 weeks. Receives: Other: Mindfulness Based Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
PSS-10 test
this is a test to measure stress level
Measured: 30 minutes test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start25 Jul 2019
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of IndonesiaStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amir S Madjid, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04279353
- Sponsor's protocol ID
- IndonesiaUAnes 045
- Status last verified
- Feb 2020
- First submitted
- 19 Feb 2020
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gurman GM, Klein M, Weksler N. Professional stress in anesthesiology: a review. J Clin Monit Comput. 2012 Aug;26(4):329-35. doi: 10.1007/s10877-011-9328-7. Epub 2011 Dec 17.
PubMed 22180163Alexander BH, Checkoway H, Nagahama SI, Domino KB. Cause-specific mortality risks of anesthesiologists. Anesthesiology. 2000 Oct;93(4):922-30. doi: 10.1097/00000542-200010000-00008.
PubMed 11020740De Hert S. Burnout Among Anesthesiologists: It׳s Time for Action! J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2467-2468. doi: 10.1053/j.jvca.2018.06.010. Epub 2018 Jun 19. No abstract available.
PubMed 30093191Hutchinson TA, Haase S, French S, McFarlane TA. Stress, Burnout and Coping among Emergency Physicians at a Major Hospital in Kingston, Jamaica. West Indian Med J. 2014 Jun;63(3):262-6. doi: 10.7727/wimj.2013.330. Epub 2014 Jun 12.
PubMed 25314285West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
PubMed 27692469
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness Based Intervention (MBI) Technique in Reducing Stress Levels of Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
- ClinicalTrials.gov ID
- NCT04279353
- Acronym / sponsor ID
- IndonesiaUAnes 045
- Conditions
- Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia
- Keywords
- Stress, Resident, Anesthesiologist, Mindfulness, Medical, Education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 25 Jul 2019 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 21 Feb 2020 (actual)
- 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.
This study was conducted to determine the effectiveness of MBI technique in reducing the stress level of anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia.
Detailed description
This research was an experimental study with paired one group design. The research subjects were anesthesiology and intensive therapy residents at the Faculty of Medicine, University of Indonesia in 2019. The MBI program lasted four weeks, consisted of one formal face-to-face training and informal training through homework carried out every day for four weeks. 13 study subjects met the inclusion criteria and did not enter the exclusion criteria. 1 study subject must be excluded because it did not complete the informal training. Data collection on the Perceived Stress Scale 10 Item (PSS-10) was conducted in July and August 2019.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Based Intervention | Experimental | Other: Mindfulness Based InterventionParticipants was asked to answer PSS-10 questionnaire to measure their stress level, then they received Mindfulness Based Intervention program for 4 weeks and did the PSS-10 test again after 4 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 |
|---|---|---|
| Mindfulness Based Interventionthis intervention is a 4 weeks program with logbook and follow up during intervention | Other | Mindfulness Based Intervention |
Primary outcome
PSS-10 test
Time frame: 30 minutes test
this is a test to measure stress level
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 21 Feb 2020.
- Results publication: PubMed 22180163Gurman GM, Klein M, Weksler N. Professional stress in anesthesiology: a review. J Clin Monit Comput. 2012 Aug;26(4):329-35. doi: 10.1007/s10877-011-9328-7. Epub 2011 Dec 17.
- Results publication: PubMed 11020740Alexander BH, Checkoway H, Nagahama SI, Domino KB. Cause-specific mortality risks of anesthesiologists. Anesthesiology. 2000 Oct;93(4):922-30. doi: 10.1097/00000542-200010000-00008.
- Results publication: PubMed 30093191De Hert S. Burnout Among Anesthesiologists: It׳s Time for Action! J Cardiothorac Vasc Anesth. 2018 Dec;32(6):2467-2468. doi: 10.1053/j.jvca.2018.06.010. Epub 2018 Jun 19. No abstract available.
- Results publication: PubMed 25314285Hutchinson TA, Haase S, French S, McFarlane TA. Stress, Burnout and Coping among Emergency Physicians at a Major Hospital in Kingston, Jamaica. West Indian Med J. 2014 Jun;63(3):262-6. doi: 10.7727/wimj.2013.330. Epub 2014 Jun 12.
- Results publication: PubMed 27692469West CP, Dyrbye LN, Erwin PJ, Shanafelt TD. Interventions to prevent and reduce physician burnout: a systematic review and meta-analysis. Lancet. 2016 Nov 5;388(10057):2272-2281. doi: 10.1016/S0140-6736(16)31279-X. Epub 2016 Sep 28.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Based Intervention in people with Anesthesiology and Intensive Therapy Residents at the Faculty of Medicine, University of Indonesia, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2020. 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 Indonesia. 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?
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?
PSS-10 test (time frame: 30 minutes test). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04279353, which also lists 5 linked publications.
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 21 Feb 2020.