Intraoperative Pauses in Relation to Stress Assessment Among Surgeons (SAFT)

November 13, 2020 updated by: Eva Angenete, Sahlgrenska University Hospital, Sweden
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden, SE 416 85
        • Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Surgery without intraoperative pause
Surgical procedure without pause
Experimental: Surgery with intraoperative pause
Three-minute long intraoperative pause, including a sugar-containing drink
Behavioral: Pause with a sugar containing drink
Three-minute long intraoperative pause, including a sugar-containing drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Salivary cortisol
Time Frame: 10 minutes
Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.
10 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Heart rate
Time Frame: 3 hours
Change in heart rate during surgery
3 hours
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.
10 minutes
Experience of the intraoperative pause.
Time Frame: 10 minutes
Questionnaire with self-experience questions - no scale
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahlgrenska University Hospital, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2019

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

September 1, 2020

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 6, 2020

First Posted (Actual)

November 12, 2020

Study Record Updates

Last Update Posted (Actual)

November 17, 2020

Last Update Submitted That Met QC Criteria

November 13, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • SAFT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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