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Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04626648
Acronym
SAFT
Enrollment
17
Registered
2020-11-12
Start date
2019-06-01
Completion date
2020-09-01
Last updated
2020-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

Brief 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. 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.

Interventions

BEHAVIORALPause with a sugar containing drink

Three-minute long intraoperative pause, including a sugar-containing drink

Sponsors

Sahlgrenska University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

A randomized controlled cross-over trial was conducted in a simulator environment

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Salivary cortisol10 minutesIntra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.

Secondary

MeasureTime frameDescription
Heart rate3 hoursChange in heart rate during surgery
self-perceived stress10 minutesmeasured 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.
Experience of the intraoperative pause.10 minutesQuestionnaire with self-experience questions - no scale

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026