Sleep and Performance in Surgeons

NCT06213246 | Unknown

• 1 other identifier: Sleep&Surgeons (L4157)
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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).

Conditions

Sleep

Keywords

surgery; sleep; surgeon; strength; cognitive performance

Outcome Measures

Primary Outcomes (1)

• Handgrip Test

  Handgrip is a measure of the maximal isometric force that a hand can squeeze, and it is widely used because very easy and inexpensive. The handgrip strength is performed three-times for each hand alternatively, starting with the dominant hand, using a digital dynamometer to the nearest 0.1kg. Participants perform the test in a sitting position with the shoulder adducted, elbow flexed at 90-degree angle, forearm in neutral position. Participants rest 30 seconds among each repetition. The peak of the three repetitions is calculated and use for statistical analysis.

  The handgrip test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 4 minutes to complete. The test is performed both before and after the surgery.

Secondary Outcomes (9)

• Lower limbs isometric strength

  The maximal isometric strength test of extensors of knee is conducted on the seventh day of both Week 2 and Week 3, taking approximately 5 minutes to complete. The test is performed both before and after the surgery.

• Sleep monitoring

  Seven days for each timepoint period (week 1, week 2 and week 3. 21 days in total)

• Stroop Test

  The Stroop test is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.

• Bomb Risk Elicitation Task

  The Bomb Risk Elicitation Task is conducted on the seventh day of both Week 2 and Week 3, taking approximately 2 minutes to complete. The test is performed both before and after the surgery.

• Salivary cortisol

  The assessment of salivary cortisol using "Salivette" is conducted on the seventh day of both Week 2 and Week 3, taking approximately 3 minutes to complete. The assessment is performed both before and after the surgery.

Study Arms (1)

Sleep Hygiene Strategies (SHS)

EXPERIMENTAL

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.

Behavioral: Sleep Hygiene Strategies

Interventions

Sleep Hygiene Strategies 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.

Sleep Hygiene Strategies (SHS)

Eligibility Criteria

• Age: 23 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio: lead

Study Sites (1)

IRCCS Ospedale Galeazzi-Sant'Ambrogio

Milan, Italy

RECRUITING

Central Study Contacts

Stefano Borghi

CONTACT

0283502246; stefano.borghi@grupposandonato.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study is monocentric, prospective, and observational.

Study Record Dates

• First Submitted: December 22, 2023
• First Posted: January 19, 2024
• Study Start: October 23, 2023
• Primary Completion: December 23, 2024
• Study Completion: December 23, 2024
• Last Updated: January 19, 2024

Record last verified: 2024-01

Locations

IT (1)