Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06008873
Status:
RECRUITING
Last Update Posted:
2023-08-24
First Post:
2023-08-13
Brief Title:
Association Between Preoperative Insomnia and Postoperative Quality of Recovery A Prospective Observational Study
Sponsor:
Sixth Affiliated Hospital Sun Yat-sen University
Organization:
Sixth Affiliated Hospital Sun Yat-sen University
Study Overview
Official Title:
Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery A Prospective Observational Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIPQoR
Brief 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 ARIand to describe preoperative sleep traits
Detailed Description:
In the single-center prospective observational study ISI is used to investigate the perceptive sleep during hospitalization waiting for surgeryand QoR-15 is used to investigate the overall quality of functional recovery at postoperative 1 3 7 14 and 30 days POD1371430 At the same time both of ARI within POD30 and neutrophil to lymphocyte ratioNLR in peripheral blood perioperation are recorded The study is divided into four phases 1 Screening on the first day of admission the subjects are screened according to the inclusion and exclusion criteria and the basic data are collected including ISI QoR-15 and depressionanxiety questionnaires et al 2 Enrollment sleep survey during hospitalization waiting for surgery ISI is performed in the day of surgery to perceive the severity of insomnia during the whole period of hospitalization waiting for surgery and objective and subjective sleep are investigated by wrist watch and sleep diary 3 Surgical and anesthesia period the key medical data related to surgery anesthesia and nursing occurred during the operation are recorded 4 Follow-up QoR-15 is investigated POD1371430 Meanwhile both of ARI and NLR are investigated
The planned enrollment is 175 subjects No randomized or any protocol-driven treatment is administered to the subjects during the study The effect size f2 of the independent variable ISI scores of hospitalization waiting for surgery on the dependent variable QoR-15 on POD1 is expected to be 01 The number of covariates is predicted to be 46 α is set as two-sided 005 and the power is 09 The sample size calculated by PASS software is 157 cases Considering 10 dropout a sample size of 175 will be required Data will be presented as meanstandard deviation median and number Logistic multivariate or multivariable models will be both performed by statisticians
The planned enrollment is 175 subjects No randomized or any protocol-driven treatment is administered to the subjects during the study The effect size f2 of the independent variable ISI scores of hospitalization waiting for surgery on the dependent variable QoR-15 on POD1 is expected to be 01 The number of covariates is predicted to be 46 α is set as two-sided 005 and the power is 09 The sample size calculated by PASS software is 157 cases Considering 10 dropout a sample size of 175 will be required Data will be presented as meanstandard deviation median and number Logistic multivariate or multivariable models will be both performed by statisticians
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None