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Completed

NCT Number: NCT04626648

Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

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.

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Key information

Conditions

Stress

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pause with a sugar containing drink

Behavioral

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

Primary outcomes

  1. Salivary cortisol

    Time frame: 10 minutes

    Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.

Secondary outcomes

  1. Heart rate

    Time frame: 3 hours

    Change in heart rate during surgery

  2. self-perceived stress

    Time frame: 10 minutes

    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.

  3. Experience of the intraoperative pause.

    Time frame: 10 minutes

    Questionnaire with self-experience questions - no scale

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Acronym: SAFT

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Nov 12, 2020
Registry last updated
Nov 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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