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临床试验/NCT06213246
NCT06213246已完成不适用

Effect of Surgery and Sleep Hygiene Strategies on Strength, Sleep Parameters, and Cognitive Performance in Orthopedic Surgeons

I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2023年10月23日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
1
主要终点
Handgrip Test

研究概览

简要总结

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).

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
23 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

研究组 & 干预措施

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.

干预措施: Sleep Hygiene Strategies (Behavioral)

结局指标

主要结局

Handgrip Test

时间窗: 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.

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.

次要结局

  • 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.)
  • Karolinska Sleepiness Scale(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.)
  • 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.)
  • Pittsburgh Sleep Quality Index(The Pittsburgh Sleep Quality Index evaluation is conducted at the end of Week 1, and taking approximately 4 minute to complete.)
  • 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))
  • Borg CR-10(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.)
  • Morningness-Eveningness Questionnaire(The Morningness-Eveningness Questionnaire is conducted at the end of Week 1, and taking approximately 4 minute to complete.)

研究者

发起方
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
申办方类型
Other
责任方
Sponsor

研究点 (1)

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