StressSAFTNCT04626648
Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
A study testing Pause with a sugar containing drink in people with Stress, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Intraoperative stress among the surgical team can be a threat to patient safety and good teamwork. During surgery, surgeons often work under stressful conditions. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Pause with a sugar containing drink
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jun 2019to 1 Sep 2020
- 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
Who may be able to join
- Surgeon within five years of specialization with basic laparoscopic skills, able to perform an appendectomy
Who cannot join
- diabetes
- Addison's disease
- medication with steroids or medication that affect heart rate (beta-blockers, calcium antagonists, antiarrhythmics, and digitalis) Smoking
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept. of Surgery, Sahlgrenska University Hospital/Ostra
Gothenburg, SE 416 85
About this study
Intraoperative stress among the surgical team can be a threat to patient safety and good teamwork. During surgery, surgeons often work under stressful conditions. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. Based on the hypothesis that an intraoperative pause including a sugar-containing drink would decrease surgeon's stress levels, the aim of this study is to compare stress levels, in relation to intraoperative stress and how this is affected by a pause including a sugar-containing drink in simulated operations.
Read the detailed description
A randomized controlled cross-over trial was conducted in a simulator environment. Primary endpoint was intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink. Secondary endpoints were change in heart rate, change in self-perceived stress measured by the State Trait Anxiety Inventory (STAI), and experience of the intraoperative pause.
- Conditions
- Stress
- Being tested
- Pause with a sugar containing drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pause with a sugar containing drinkBehavioural
Three-minute long intraoperative pause, including a sugar-containing drink
| Study group | Role | What they receive |
|---|---|---|
| Surgery without intraoperative pause | No intervention | Surgical procedure without pause |
| Surgery with intraoperative pause | Experimental | Three-minute long intraoperative pause, including a sugar-containing drink Receives: Behavioral: Pause with a sugar containing drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary cortisol
Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.
Measured: 10 minutes
Secondary outcomes (3)
Heart rate
Change in heart rate during surgery
Measured: 3 hours
self-perceived stress
measured by the State Trait Anxiety Inventory (STAI) Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for ten S-Anxiety items and eleven T-Anxiety items. A high rating indicates the absence of anxiety for the remaining ten S-Anxiety items and nine T-Anxiety items.
Measured: 10 minutes
Experience of the intraoperative pause.
Questionnaire with self-experience questions - no scale
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start1 Jun 2019
- Primary completion1 Dec 2019
- Study completion1 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- More trials run by Sahlgrenska University HospitalThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized controlled cross-over trial was conducted in a simulator environment
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Angenete, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04626648
- Sponsor's protocol ID
- SAFT
- Acronym
- SAFT
- Status last verified
- Nov 2020
- First submitted
- 6 Nov 2020
- Last updated
- 17 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Erestam S, Bock D, Andersson AE, Haglind E, Park J, Angenete E. The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers. Patient Saf Surg. 2021 May 29;15(1):23. doi: 10.1186/s13037-021-00294-6.
PubMed 34051829
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
- ClinicalTrials.gov ID
- NCT04626648
- Acronym / sponsor ID
- SAFT / SAFT
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 12 Nov 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.
Intraoperative stress among the surgical team can be a threat to patient safety and good teamwork. During surgery, surgeons often work under stressful conditions. Reducing intraoperative stress for surgeons could benefit surgeons and subsequently patients. Based on the hypothesis that an intraoperative pause including a sugar-containing drink would decrease surgeon's stress levels, the aim of this study is to compare stress levels, in relation to intraoperative stress and how this is affected by a pause including a sugar-containing drink in simulated operations.
Detailed description
A randomized controlled cross-over trial was conducted in a simulator environment. Primary endpoint was intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink. Secondary endpoints were change in heart rate, change in self-perceived stress measured by the State Trait Anxiety Inventory (STAI), and experience of the intraoperative pause.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled cross-over trial was conducted in a simulator environment
| Arm | Type | Receives |
|---|---|---|
| Surgery without intraoperative pause | No intervention | –Surgical procedure without pause |
| Surgery with intraoperative pause | Experimental | Behavioral: Pause with a sugar containing drinkThree-minute long intraoperative pause, including a sugar-containing drink |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Surgeon within five years of specialization with basic laparoscopic skills, able to perform an appendectomy
Key exclusion criteria (3 listed)
- diabetes
- Addison's disease
- medication with steroids or medication that affect heart rate (beta-blockers, calcium antagonists, antiarrhythmics, and digitalis) Smoking
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 |
|---|---|---|
| Pause with a sugar containing drinkThree-minute long intraoperative pause, including a sugar-containing drink | Behavioural | Surgery with intraoperative pause |
Primary outcome
Salivary cortisol
Time frame: 10 minutes
Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.
3 secondary outcomes
Heart rate
Time frame: 3 hours
self-perceived stress
Time frame: 10 minutes
Experience of the intraoperative pause.
Time frame: 10 minutes
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 17 Nov 2020.
- Derived from this study: PubMed 34051829Erestam S, Bock D, Andersson AE, Haglind E, Park J, Angenete E. The perceived benefit of intraoperative stress modifiers for surgeons: an experimental simulation study in volunteers. Patient Saf Surg. 2021 May 29;15(1):23. doi: 10.1186/s13037-021-00294-6.
- Individual participant dataSharing planned: Undecided
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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.
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 Pause with a sugar containing drink in people with Stress, run by Sahlgrenska University Hospital at 1 site in Sweden.
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 3 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 17 Nov 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 Sweden. 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?
Salivary cortisol (time frame: 10 minutes). 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 NCT04626648, which also lists 1 linked publication.
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 17 Nov 2020.