Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective O… (NCT06008873) | Clinical Trial Compass
CompletedNot Applicable
Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study
China198 participantsStarted 2023-02-15
Plain-language summary
Although patients with cancers are prone to insomnia, especially waiting for surgery during hospitalization, and insomnia promotes acute respiratory infections (ARI) and is not conducive to the postoperative quality of recovery (QoR), evidence that preoperative insomnia delays postoperative recovery is still lacking. In this prospective observational study, we enroll 175 non-elderly subjects with abdominal cancer who will undergo non-emergency cancer resection surgery. Insomnia Severity Index scale (ISI) is used to assess the insomnia severity during hospitalization while awaiting surgery. The Quality of Recovery-15 (QoR-15) is used to evaluate the overall recovery after surgery. Meanwhile, wrist watch and sleep diary are used to record sleep. The aim of the study is to investigate the association between preoperative insomnia and postoperative QoR, the association between preoperative insomnia and postoperative ARI,and to describe preoperative sleep traits.
Who can participate
Age range
18 Years – 64 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 1.Voluntarily execute informed consent;
* 2.Effective linguistic communication and collaboration;
* 3.No history of mental disorders;
* 4.Age of 18-64 years old, male or female;
* 5.BMI 18-30kg/m2;
* 6.American Society of anesthesiology (ASA) grade 1-2, New York Heart Association(NYHA) grade Ⅰ or Ⅱ;
* 7.Initial diagnosis of abdominal cancers and the diagnosis has been disclosed to subjects;
* 8.Non-emergency cancer resection surgery is planned;
* 9.The planned anesthesia is general anesthesia with endotracheal intubation.
Exclusion Criteria:
* 1.Obstructive apnea syndrome, narcolepsy, restless leg/periodic limb movement disorder, sleepwalking disorder, nightmare disorder;
* 2.Not suitable to participate in the study.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Total scores of the questionnaire of Insomnia Severity Scale (ISI) on the day before surgery or the day of surgery
Timeframe: on the day before surgery or the day of surgery
2
Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
Timeframe: on postoperative day 1
Trial details
NCT IDNCT06008873
SponsorSixth Affiliated Hospital, Sun Yat-sen University