Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

NCT04626648 | Completed

• 1 other identifier: SAFT
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• Salivary cortisol

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

  10 minutes

Secondary Outcomes (3)

• Heart rate

  3 hours

• self-perceived stress

  10 minutes

• Experience of the intraoperative pause.

  10 minutes

Study Arms (2)

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

Behavioral: Pause with a sugar containing drink

Interventions

Pause with a sugar containing drink BEHAVIORAL

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

Surgery with intraoperative pause

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgeon within five years of specialization with basic laparoscopic skills, able to perform an appendectomy

You may not qualify if:

• diabetes
• Addison's disease
• medication with steroids or medication that affect heart rate (beta-blockers, calcium antagonists, antiarrhythmics, and digitalis) Smoking

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, SE 416 85, Sweden

Location

Related Publications (1)

• 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.

  PMID: 34051829 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

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

Study Record Dates

• First Submitted: November 6, 2020
• First Posted: November 12, 2020
• Study Start: June 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: September 1, 2020
• Last Updated: November 17, 2020

Record last verified: 2020-11

Locations

SE (1)