Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

Stress Clinical Trial

— SAFT  

Official title:

Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04626648
• Other study ID #: SAFT
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: September 1, 2020

Study information

• Verified date: November 2020
• Source: Sahlgrenska University Hospital, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: September 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Pause with a sugar containing drink
Three-minute long intraoperative pause, including a sugar-containing drink

Locations

Country	Name	City	State
Sweden	Dept. of Surgery, Sahlgrenska University Hospital/Ostra	Gothenburg

Sponsors (1)

Lead Sponsor	Collaborator
Sahlgrenska University Hospital, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Salivary cortisol	Intra-individual change in salivary cortisol between simulations with or without a pause including a sugar containing drink.	10 minutes
Secondary	Heart rate	Change in heart rate during surgery	3 hours
Secondary	self-perceived stress	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
Secondary	Experience of the intraoperative pause.	Questionnaire with self-experience questions - no scale	10 minutes