Clinical trial · Observational
Association Between Preoperative Insomnia and Postoperative Quality of Recovery : A Prospective Observational Study
Association Between Preoperative Insomnia and Postoperative Quality of Recovery in Non-elderly Patients Undergoing Non-emergency Cancer Resection Surgery: A Prospective Observational Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Sleep Disorder | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- One group only
- description
- No intervention.
Primary outcomes (2)
- measure
- 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
- description
- ISI is used to assess insomnia during the time when waiting for surgery in hospital from the day of admission to the day of surgery. ISI is used to assess how satisfied with sleep patterns and psychological distress or impairments in daytime functioning associated with sleep difficulties. ISI is filled in by subjects on the day before surgery or the day of surgery. ISI contents 7 items, which item is measured by an 0-4 point rating scale (0="very satisfaction"; 4="very dissatisfaction"). ISI total scores range from 0 to 28, with higher scores indicating higher severity of insomnia.
- measure
- Total scores of the questionnaire of 15-item Quality of Recovery scale (QoR-15）on postoperative day 1
- timeFrame
- on postoperative day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 64 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available