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Intraoperative Pauses in Relation to Stress Assessment Among Surgeons

NCT ID: NCT04626648

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2020-09-01

Brief Summary

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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

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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.

Conditions

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Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomized controlled cross-over trial was conducted in a simulator environment
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Surgery without intraoperative pause

Surgical procedure without pause

Group Type NO_INTERVENTION

No interventions assigned to this group

Surgery with intraoperative pause

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

Group Type EXPERIMENTAL

Pause with a sugar containing drink

Intervention Type BEHAVIORAL

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

Interventions

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Pause with a sugar containing drink

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sahlgrenska University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eva Angenete

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dept. of Surgery, Sahlgrenska University Hospital/Ostra

Gothenburg, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 34051829 (View on PubMed)

Other Identifiers

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SAFT

Identifier Type: -

Identifier Source: org_study_id