Sleep and Performance in Surgeons

NCT ID: NCT06213246

Last Updated: 2024-01-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-23
• Study Completion Date: 2024-12-23

Brief Summary

The primary aim of this study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes in actigraphic sleep parameters, salivary cortisol levels, cognitive performance, and subjective perception levels of effort and drowsiness.

Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (week 2 vs week 3).

Detailed Description

Currently, there are few scientific studies that have assessed the relationship between sleep quality, strength expression, and cognitive performance among orthopedic surgeons. Furthermore, no previous study has ever evaluated the effect of a behavioral sleep hygiene strategy on actigraphic sleep parameters in orthopedic surgeons.

Therefore, the primary aim of the study is to assess the changes in strength expression resulting from the performance of a surgical operation among orthopedic surgeons at the IRCCS Galeazzi-Sant'Ambrogio Hospital. To achieve this goal, the assessment of strength expression will be conducted using handgrip measurements before (pre) and after (post) the surgical operation. Additionally, both pre- and post-surgery, there will also be evaluations of changes on lower limbs strength (maximal isometric strength of extensors of knee by digital dynamometer), salivary cortisol levels, cognitive performance (Stroop test and Bomb Risk Elicitation Task), and subjective perception levels of effort and drowsiness (Borg CR-10 and Karolinska Sleepiness Scale).

Te second aim is to assess differences in strength expression, cognitive performance, salivary cortisol levels, perceived effort, and drowsiness levels among surgeons in response to sleep hygiene strategies (control week vs Sleep hygiene strategies week).

The study involves 3 weeks of assessment (Week 1, 2, and 3), not necessarily consecutive.

Assessments within Week 1:

• Sleep monitoring using actigraphy and a sleep diary for the entire week, along with completing the Morningness-Eveningness Questionnaire and Pittsburgh Sleep Quality Index.

Assessments within Week 2 and Week 3:

• Sleep monitoring using actigraphy and a sleep diary for the entire week.
• Pre and post-surgical operation evaluations:

• Measurement of strength using dynamometers.
• Cognitive assessment using Stroop test and Bomb Risk Elicitation Task.
• Evaluation of salivary cortisol levels using "Salivette".
• Assessment of perceived exertion using the Borg CR10 scale.
• Evaluation of drowsiness levels using the Karolinska Sleepiness Scale.

Note: In Week 3, sleep hygiene strategies will be implemented.

Conditions

Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Sleep Hygiene Strategies (SHS)

In Week 3, the study participants will implement sleep hygiene strategies. Specifically, these sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the guidelines recommended by the National Sleep Foundation.

Group Type: EXPERIMENTAL

Sleep Hygiene Strategies

Intervention Type: BEHAVIORAL

The sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the following guidelines recommended by the National Sleep Foundation

• Maintain a consistent wake-up and bedtime schedule during workdays.
• Do not delay/advance excessively (no more than 2 hours) the wake-up and bedtime - schedule during weekends.
• Keep the bedroom temperature below 22°C.
• Avoid sources of light and noise in the bedroom.
• Use the bed only for sleeping, avoiding other activities before bedtime.
• Avoid daytime naps during workdays.
• Refrain from using electronic devices (PC, laptop, cellphone, television) at least 30 minutes before bedtime.
• Expose yourself to natural light in the morning and reduce artificial lights in the evening.
• Avoid consuming alcoholic beverages and caffeine in the afternoon.
• Have a moderately sized dinner at least 3 hours before bedtime.

Interventions

Sleep Hygiene Strategies

The sleep hygiene strategies will be applied for all seven days of Week 3 and will involve the following guidelines recommended by the National Sleep Foundation

• Maintain a consistent wake-up and bedtime schedule during workdays.
• Do not delay/advance excessively (no more than 2 hours) the wake-up and bedtime - schedule during weekends.
• Keep the bedroom temperature below 22°C.
• Avoid sources of light and noise in the bedroom.
• Use the bed only for sleeping, avoiding other activities before bedtime.
• Avoid daytime naps during workdays.
• Refrain from using electronic devices (PC, laptop, cellphone, television) at least 30 minutes before bedtime.
• Expose yourself to natural light in the morning and reduce artificial lights in the evening.
• Avoid consuming alcoholic beverages and caffeine in the afternoon.
• Have a moderately sized dinner at least 3 hours before bedtime.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Male or female, of any ethnicity;
• Age between 23 and 70 years old;
• Cognitively intact;
• Orthopedic surgeons or medical residents specializing in Orthopedics.
• Signature and acceptance of informed consent to collaborate in all procedures necessary for the study.

Exclusion Criteria

• Individuals younger than 23 years old or older than 70 years old;
• Any clinical condition that prevents the subject from participating in operating room activities (e.g., muscle injury, COVID-19 positivity, feverish or flu-like states, etc.).
• Non-participation, for any reason, in surgical activities in daily clinical practice.
• Clinically diagnosed sleep disorders.
• Women who have been pregnant or breastfeeding within 12 months before signing the informed consent or during the recruitment and observation period. [self-declaration]
• Non-acceptance of the informed consent.
• Physical impossibility to undergo the evaluations required by the study using the devices specified in the protocol.

• Minimum Eligible Age: 23 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stefano Borghi

Role: CONTACT

stefano.borghi@grupposandonato.it

0283502246

Facility Contacts

Stefano Borghi, Md

Role: primary

Other Identifiers

Sleep&Surgeons (L4157)

Identifier Type: -

Identifier Source: org_study_id