Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Pause with a sugar containing drink

• Registration Number: NCT04626648
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Study Timeline

• Study Start: 2019-06-01
• Primary Completion: 2019-12-01
• Study Completion: 2020-09-01
• Status Verified: 2020-11
• Study First Submitted: 2020-11-06
• Study First Submitted QC: 2020-11-06
• Study First Posted: 2020-11-12
• Last Update Submitted: 2020-11-13
• Last Update Posted: 2020-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Surgery with intraoperative pause	Pause with a sugar containing drink	Three-minute long intraoperative pause, including a sugar-containing drink

Primary Outcome Measures

Name	Time	Method
Salivary cortisol	10 minutes	Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.

Secondary Outcome Measures

Name	Time	Method
Heart rate	3 hours	Change in heart rate during surgery
self-perceived stress	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.
Experience of the intraoperative pause.	10 minutes	Questionnaire with self-experience questions - no scale

Trial Locations

Locations (1)

Dept. of Surgery, Sahlgrenska University Hospital/Ostra; 🇸🇪 Gothenburg, Sweden