This is an observational clinical study. It does not give new treatments to participants. Researchers want to learn how sleep gets better or worse after laparoscopic gallbladder removal surgery. Sleep problems are common after surgery. Some people may recover their sleep faster than others. Researchers will look at whether sleep recovery differs between women and men. They will also check how sex-related hormone levels connect with sleep changes.
About 58 participants will join this study.
Key requirements to take part:
* Aged 18 to 65 years old * Scheduled for laparoscopic gallbladder removal under general anesthesia * Able to give informed consent and finish all study tasks * Can tolerate repeated blood draws * No long-term sleep-affecting medicine use in the past one month * Major organs work normally
People cannot join if they:
* Are younger than 18 years or older than 65 years * Are pregnant or breastfeeding * Have mental health or cognitive conditions that stop study participation * Have problems that make repeated blood collection unsafe * Have severe organ diseases or recent major injury or surgery * Have alcohol or drug dependence
What happens for each participant:
1. Before surgery: Participants sign consent forms. Staff collect basic health information. Participants wear a sleep-recording device called polysomnography (PSG) overnight. Participants fill out a short sleep diary each morning. Fasting blood samples are collected the next morning to measure hormone levels. 2. On surgery day: Standard hospital care goes forward. Staff record surgery-related information. PSG sleep recording, sleep diary, and morning blood draw are repeated. 3. First and second days after surgery: The same sleep recording, sleep diary, and morning fasting blood collection continue for two more nights.
Researchers compare sleep measurements across four nights. These measurements come from both PSG machine readings and participants' self-reported sleep diaries. Researchers also compare hormone level changes between female and male participants.
Possible benefits: Participants receive objective feedback on their own sleep and hormone results. If test values show clear concerns, researchers share these findings with their clinical care team. No direct treatment benefit is guaranteed.
Possible risks: This is a low-risk study. Small risks may include mild pain, bruising at blood draw sites, or temporary light-headedness from blood collection. Filling out short diaries may bring minor tiredness. All personal data will be kept private. Participants can leave the study at any time with no penalty.
Aged 18-65 years of both genders. Alert and capable of normal communication. Voluntarily sign informed consent, complete the whole experimental procedure, and meet ethical and compliance requirements.
Patients scheduled to undergo laparoscopic cholecystectomy under general anesthesia.
No history of severe needle or blood phobia, and able to tolerate repeated venous blood sampling during the perioperative period.
No long-term use of sedative-hypnotics, anxiolytics, antidepressants, or glucocorticoids within the past month, except for short-term use for acute illness for no more than 3 days; no other interventions that may affect sleep, such as transcranial magnetic stimulation or cognitive behavioral therapy.
1: Aged <18 years or >65 years; pregnant or breastfeeding women; patients with psychiatric disorders, such as schizophrenia, mania, or depression, cognitive impairment, or inability to cooperate with the study, in order to avoid missing data or study bias due to poor cooperation.
This study is a prospective observational study designed to compare the recovery trajectories of perioperative stress-related sleep disturbances between male and female patients undergoing laparoscopic cholecystectomy. All enrolled participants will be naturally assigned to either the female group or the male group according to sex, without any study-related intervention.
Case-control
Retrospective
No study intervention
Other interventionThis is a retrospective observational study based on existing medical records. No intervention, treatment, or procedure is assigned or administered by the study investigators. All data are collected retrospectively from routine clinical care.
Wake After Sleep Onset (WASO), measured in minutes by polysomnography
Wake after sleep onset (WASO) is defined as the total amount of time spent awake after initial sleep onset and before final awakening during the monitoring period. WASO will be measured in minutes using polysomnography (PSG). A higher WASO indicates a greater amount of wakefulness during the sleep period.
Proportions of Rapid Eye Movement (REM) Sleep, Non-Rapid Eye Movement (NREM) Sleep, and Wakefulness measured by polysomnography
Sleep and wake states will be determined using polysomnography (PSG). The proportions of rapid eye movement (REM) sleep, non-rapid eye movement (NREM) sleep, and wakefulness will be calculated as the percentage of the total recording time spent in each state. Values will be reported as percentages (%), with higher values indicating a greater proportion of the recording period spent in the corresponding state.
Proportions of N1, N2, and N3 stages of non-rapid eye movement (NREM) sleep measured by polysomnography
Sleep stages will be determined using polysomnography (PSG). The proportions of N1, N2, and N3 sleep will be calculated as the percentage of total sleep time (TST) spent in each respective NREM sleep stage. Values will be reported as percentages (%). Higher values indicate a greater proportion of total sleep time spent in the corresponding sleep stage.
Sleep Onset Latency (SOL), measured in minutes by polysomnography
Sleep onset latency (SOL) is defined as the time from the beginning of the sleep opportunity to the onset of sleep, as determined by polysomnography (PSG). SOL will be reported in minutes. A higher value indicates a longer time required to initiate sleep.
Sleep satisfaction (rated on a scale of 1-10, with 1 indicating very dissatisfied and 10 indicating very satisfied)
number of nighttime awakenings (subjectively perceived)
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Li Juan
Lead sponsor
Anhui Provincial Hospital
Sponsor institution
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