Clinical trial NCT06213246: Sleep and Performance in Surgeons
Official title: Effect of Surgery and Sleep Hygiene Strategies on Strength, Sleep Parameters, and Cognitive Performance in Orthopedic Surgeons
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep
Keywords: surgery
sleep
surgeon
strength
cognitive performance
Lead sponsor: I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
Sponsor class: OTHER
First posted: 2024-01-19
Enrollment: 23
Sex: ALL
Minimum age (years): 23
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The study is monocentric, prospective, and observational.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Handgrip Test
timeFrame: 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:
measure: Lower limbs isometric strength
timeFrame: 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.
measure: Sleep monitoring
timeFrame: Seven days for each timepoint period (week 1, week 2 and week 3. 21 days in total)
measure: Stroop Test
timeFrame: 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.
measure: Bomb Risk Elicitation Task
timeFrame: 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.
measure: Salivary cortisol
timeFrame: 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.
measure: Borg CR-10
timeFrame: The Borg CR-10 evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
measure: Karolinska Sleepiness Scale
timeFrame: The Karolinska Sleepiness Scale evaluation is conducted on the seventh day of both Week 2 and Week 3, taking approximately 1 minute to complete. The assessment is performed both before and after the surgery.
measure: Pittsburgh Sleep Quality Index
timeFrame: The Pittsburgh Sleep Quality Index evaluation is conducted at the end of Week 1, and taking approximately 4 minute to complete.
measure: Morningness-Eveningness Questionnaire
timeFrame: The Morningness-Eveningness Questionnaire is conducted at the end of Week 1, and taking approximately 4 minute to complete.
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Ospedale Galeazzi-Sant'Ambrogio
Study officials:
References: