Stress Clinical Trial
— SAFTOfficial title:
Intraoperative Pauses in Relation to Stress Assessment Among Surgeons
NCT number | NCT04626648 |
Other study ID # | SAFT |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 1, 2019 |
Est. completion date | September 1, 2020 |
Verified date | November 2020 |
Source | Sahlgrenska University Hospital, Sweden |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 17 |
Est. completion date | September 1, 2020 |
Est. primary completion date | December 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Surgeon within five years of specialization with basic laparoscopic skills, able to perform an appendectomy Exclusion Criteria: - diabetes - Addison's disease - medication with steroids or medication that affect heart rate (beta-blockers, calcium antagonists, antiarrhythmics, and digitalis) Smoking |
Country | Name | City | State |
---|---|---|---|
Sweden | Dept. of Surgery, Sahlgrenska University Hospital/Ostra | Gothenburg |
Lead Sponsor | Collaborator |
---|---|
Sahlgrenska University Hospital, Sweden |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Salivary cortisol | Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink. | 10 minutes | |
Secondary | Heart rate | Change in heart rate during surgery | 3 hours | |
Secondary | 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. | 10 minutes | |
Secondary | Experience of the intraoperative pause. | Questionnaire with self-experience questions - no scale | 10 minutes |
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